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See termination reason in detailed description.
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| Name | Class |
|---|---|
| London School of Hygiene and Tropical Medicine | OTHER |
| Medicines for Malaria Venture | OTHER |
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The primary objective is to establish superiority of AZCQ over SP in protective efficacy for IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.
After interim analysis of efficacy data by an External Data Monitoring Committee, this study was terminated. Investigators were notified on 22 Aug 2013. There were no safety concerns that led to this termination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZCQ | Experimental | Azithromycin/chloroquine |
|
| SP | Active Comparator | sulfadoxine-pyrimethamine (Fansidar) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin plus chloroquine | Drug | combination tablet of 250mg azithromycin/155 chloroquine, Once daily PO for three days per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population | Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with low birth weight (LBW) (<2,500 g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates. | Approximately 40 weeks of gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population | Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with LBW (<2,500g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Santé d'AHOUANSORI-AGUE | Cotonou | Benin | Benin | |||
| Hôpital Bethesda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29566732 | Derived | Mtove G, Kimani J, Kisinza W, Makenga G, Mangesho P, Duparc S, Nakalembe M, Phiri KS, Orrico R, Rojo R, Vandenbroucke P. Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings. Trials. 2018 Mar 22;19(1):190. doi: 10.1186/s13063-018-2563-1. | |
| 27326859 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pregnant women (all gravidae) with ≥14 and ≤26 weeks of gestational age were to be enrolled in this study. Approximately half of the participants were to be primigravidae and secundigravidae pregnant women since they had a higher risk for suboptimal pregnancy outcomes due to malaria.
This Phase 3, open label, randomized, parallel group study screened a total of 3259 participants in 6 sites. A total of 2891 were treated either with azithromycin+chloroquine or sulfadoxine+pyrimethamine.
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| ID | Title | Description |
|---|---|---|
| FG000 | Azithromycin + Chloroquine | The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| sulfadoxine-pyrimethamine | Drug | Fansidar tablet (500 mg sulfadoxine /25 mg pyrimethamine), once daily, PO, single dose per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation. |
|
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| Approximately 40 weeks of gestational age |
| Percentage of Neonates With LBW (<2500 g) in ITT Population | LBW was defined as live birth weight <2500 g (up to and including 2499 g). | Approximately 40 weeks of gestational age |
| Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population | LBW was defined as live birth weight <2500 g (up to and including 2499 g). | Approximately 40 weeks of gestational age |
| Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation | Severe maternal anemia was defined as Hb <8 g/dL. | At 36-38 weeks of gestation. |
| Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation | Anemia was defined as Hb <11 g/dL. | At 36-38 weeks of gestation. |
| Percentage of Participants With Placental Parasitemia at Delivery | Participants with placental parasitemia at delivery were diagnosed using Placental blood smear at birth from participants who deliver at hospital. | Approximately 40 weeks of gestational age |
| Percentage of Participants With Placental Malaria at Delivery Based on Histology | Participants positive for placental malaria at delivery were evaluated based on placental histology. | Approximately 40 weeks of gestational age |
| Sexually Transmitted Infection (STI) Episodes Per Participant | Number of episodes of sexually transmitted infection episodes per participant were noted. The STI's including Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis, from first dose to delivery (diagnosis was based on clinical presentation and lab results). | Approximately 40 weeks of gestational age . |
| Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation | Sub-optimal pregnancy outcome including neonatal deaths and congenital malformations, defined as any of the following: live-borne neonate (singleton) with low birth-weight (or LBW for short, defined as live birth weight <2,500g), premature birth (<37 weeks), abortion (≤28 weeks), still birth (>28 weeks), neonatal death, congenital malformation, lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates. | Approximately 40 weeks of gestational age. |
| Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration. | Change from Baseline to 36-38 weeks of gestation in Hb concentration was noted. | Baseline, at 36-38 weeks of gestation. |
| Percentage of Neonates With Congenital Abnormalities at Birth | Neonates with congenital abnormalities at birth were noted. | Approximately 40 weeks of gestational age. |
| Percentage of Perinatal or Neonatal Deaths | Percentage of perinatal or neonatal deaths were noted. | Day 28 after delivery. |
| Birth Weight of Live Borne Neonate | Birth weight of live borne neonates were calculated in grams. | Approximately 40 weeks of gestational age. |
| Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery | This outcome measure determined if an episode of malaria started within the time period of first dose to delivery. Clinical episode of malaria was determined if the participant presented with clinical symptoms of malaria (fever >37.5°C, oral) and diagnosed (either by rapid diagnostic tests or microscopy) with malaria. | Approximately 40 weeks of gestational age |
| Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery | This outcome measure evaluated the participants requiring additional treatments for malaria during the study period following the first dose (diagnosed based on clinical presentation and/or lab test results). | Approximately 40 weeks of gestational age |
| Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation | This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at 36-38 weeks of gestation. A participant was positive for parasitemia if the number of asexual parasites per μL was >0. | At 36-38 weeks of gestation |
| Percentage of Participants With Peripheral Parasitemia at Delivery | This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0. | Approximately 40 weeks of gestational age |
| Percentage of Participants With Cord Blood Parasitemia at Delivery | This outcome measure evaluated the percentage of participants positive for cord blood parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0. | Approximately 40 weeks of gestational age |
| Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation | Sexual transmitted disease included Treponema pallidum, Neisseria gonorrhoeae, and Chlamydia trachomatis infections. This was diagnosed based on clinical presentation prior to Week 36-38 and/or lab test results between Week 36-38. | Upto 36-38 weeks of gestation |
| Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation | Participants positive for Chlamydia trachomatis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis. | At 36-38 weeks of gestation |
| Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation | Participants positive for Neisseria gonorrhoeae infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis. | At 36-38 weeks of gestation |
| Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation | Participants positive for Treponema pallidum infection was diagnosed based on laboratory result at 36-38 weeks of gestation. Treponema Pallidum particle Agglutination Assay was used. | At 36-38 weeks of gestation |
| Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation | Participants positive for Trichomonas vaginalis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the laboratory test. | At 36-38 weeks of gestation |
| Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation. | Bacterial vaginosis was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the Gram staining. | At 36-38 weeks of gestation |
| Percentage of Neonates With Ophthalmia Neonatorum at Birth Period | Ophthalmia neonatorum was diagnosed at birth. The laboratory diagnosis was performed among neonates with purulent discharge. | Approximately 40 weeks of gestational age |
| Percentage of Participants With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery | Participants positive for bacterial infections including other lower respiratory tract infections were measured anytime from first dose administration to delivery. | Up to approximately 40 weeks of gestational age |
| Percentage of Participants With Pre-eclampsia From Week 20 to Delivery | Pre-eclampsia was diagnosed as systolic blood pressure of at least 140 mmHg and/or diastolic blood pressure of at least 90 mmHg on two separate readings taken at least 4 hours apart and proteinuria at least 300 mg protein in a 24 hour urine collection. | From Week 20 to approximately 40 weeks of gestational age |
| Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae | This outcome measure evaluated the Streptococcus pneumoniae sensitivity against macrolide antibiotics. | Visits 6 and 7 |
| Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae | This outcome measure evaluated the Streptococcus pneumoniae sensitivity against penicillin antibiotics. | Visits 6 and 7 |
| Cotonou |
| Benin |
| Siaya District Hospital | Siaya | Siaya County | Kenya |
| Zomba Central Hospital | Zomba | Malawi |
| Teule Hospital | Muheza | Tanga | Tanzania |
| Nyamagana District Hospital | Mwanza | Tanzania | Tanzania |
| Bugando Medical Centre | Mwanza | 1903 | Tanzania |
| Nyamagana District Hospital, c/o National Institute for Medical Research, Mwanza Centre | Mwanza | Tanzania |
| Mulago Hospital Complex | Kampala | Uganda |
| Kimani J, Phiri K, Kamiza S, Duparc S, Ayoub A, Rojo R, Robbins J, Orrico R, Vandenbroucke P. Efficacy and Safety of Azithromycin-Chloroquine versus Sulfadoxine-Pyrimethamine for Intermittent Preventive Treatment of Plasmodium falciparum Malaria Infection in Pregnant Women in Africa: An Open-Label, Randomized Trial. PLoS One. 2016 Jun 21;11(6):e0157045. doi: 10.1371/journal.pone.0157045. eCollection 2016. |
| Sulfadoxine + Pyrimethamine |
The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Azithromycin + Chloroquine | The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals. |
| BG001 | Sulfadoxine + Pyrimethamine | The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population | Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with low birth weight (LBW) (<2,500 g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. | Posted | Number | 95% Confidence Interval | Percentage of participants | Approximately 40 weeks of gestational age |
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| Secondary | Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population | Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with LBW (<2,500g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates. | Subset of ITT participants: outcome or withdrawal occurred on or before 8/27/2013 (date of study termination), compliant with study medication, birth weight measured on or before 7 days after birth if not already a failure, and did not switch to standard of care. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Approximately 40 weeks of gestational age |
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| Secondary | Percentage of Neonates With LBW (<2500 g) in ITT Population | LBW was defined as live birth weight <2500 g (up to and including 2499 g). | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Total live births. | Posted | Number | 95% Confidence Interval | Percentage of neonates | Approximately 40 weeks of gestational age |
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| Secondary | Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population | LBW was defined as live birth weight <2500 g (up to and including 2499 g). | Subset of ITT participants: outcome or withdrawal occurred on or before 8/27/2013 (date of study termination), compliant with study medication, birth weight measured on or before 7 days after birth if not already a failure, and did not switch to standard of care. N=Total Live Births. | Posted | Number | 95% Confidence Interval | Percentage of neonates | Approximately 40 weeks of gestational age |
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| Secondary | Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation | Severe maternal anemia was defined as Hb <8 g/dL. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with Hb measurement at 36-38 weeks gestation. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 36-38 weeks of gestation. |
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| Secondary | Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation | Anemia was defined as Hb <11 g/dL. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with Hb measurement at 36-38 weeks gestation. | Posted | Number | 95% Confidence Interval | Percentage of Participants | At 36-38 weeks of gestation. |
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| Secondary | Percentage of Participants With Placental Parasitemia at Delivery | Participants with placental parasitemia at delivery were diagnosed using Placental blood smear at birth from participants who deliver at hospital. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with placental parasite counts at delivery. | Posted | Number | 95% Confidence Interval | Percentage of participants | Approximately 40 weeks of gestational age |
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| Secondary | Percentage of Participants With Placental Malaria at Delivery Based on Histology | Participants positive for placental malaria at delivery were evaluated based on placental histology. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with a histology parasite evaluation at delivery. | Posted | Number | 95% Confidence Interval | Percentage of participants | Approximately 40 weeks of gestational age |
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| Secondary | Sexually Transmitted Infection (STI) Episodes Per Participant | Number of episodes of sexually transmitted infection episodes per participant were noted. The STI's including Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis, from first dose to delivery (diagnosis was based on clinical presentation and lab results). | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with available data. | Posted | Least Squares Mean | 95% Confidence Interval | Number of episodes | Approximately 40 weeks of gestational age . |
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| Secondary | Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation | Sub-optimal pregnancy outcome including neonatal deaths and congenital malformations, defined as any of the following: live-borne neonate (singleton) with low birth-weight (or LBW for short, defined as live birth weight <2,500g), premature birth (<37 weeks), abortion (≤28 weeks), still birth (>28 weeks), neonatal death, congenital malformation, lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Total Outcomes. | Posted | Number | 95% Confidence Interval | Percentage of participants | Approximately 40 weeks of gestational age. |
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| Secondary | Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration. | Change from Baseline to 36-38 weeks of gestation in Hb concentration was noted. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with available data. | Posted | Least Squares Mean | 95% Confidence Interval | g/dL | Baseline, at 36-38 weeks of gestation. |
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| Secondary | Percentage of Neonates With Congenital Abnormalities at Birth | Neonates with congenital abnormalities at birth were noted. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of total live births. | Posted | Number | 95% Confidence Interval | Percentage of neonates | Approximately 40 weeks of gestational age. |
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| Secondary | Percentage of Perinatal or Neonatal Deaths | Percentage of perinatal or neonatal deaths were noted. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of total live births. | Posted | Number | 95% Confidence Interval | Percentage of neonates | Day 28 after delivery. |
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| Secondary | Birth Weight of Live Borne Neonate | Birth weight of live borne neonates were calculated in grams. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of live births with available data. | Posted | Least Squares Mean | 95% Confidence Interval | grams | Approximately 40 weeks of gestational age. |
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| Secondary | Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery | This outcome measure determined if an episode of malaria started within the time period of first dose to delivery. Clinical episode of malaria was determined if the participant presented with clinical symptoms of malaria (fever >37.5°C, oral) and diagnosed (either by rapid diagnostic tests or microscopy) with malaria. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. | Posted | Least Squares Mean | 95% Confidence Interval | Number of episodes | Approximately 40 weeks of gestational age |
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| Secondary | Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery | This outcome measure evaluated the participants requiring additional treatments for malaria during the study period following the first dose (diagnosed based on clinical presentation and/or lab test results). | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. | Posted | Number | 95% Confidence Interval | Percentage of participants | Approximately 40 weeks of gestational age |
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| Secondary | Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation | This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at 36-38 weeks of gestation. A participant was positive for parasitemia if the number of asexual parasites per μL was >0. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N = Number of participants with peripheral blood smear parasite counts at 36-38 weeks of gestation. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 36-38 weeks of gestation |
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| Secondary | Percentage of Participants With Peripheral Parasitemia at Delivery | This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N = Number of participants with peripheral blood smear parasite counts at delivery. | Posted | Number | 95% Confidence Interval | Percentage of participants | Approximately 40 weeks of gestational age |
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| Secondary | Percentage of Participants With Cord Blood Parasitemia at Delivery | This outcome measure evaluated the percentage of participants positive for cord blood parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N = Number of participants with cord blood smear parasite counts at delivery. | Posted | Number | 95% Confidence Interval | Percentage of participants | Approximately 40 weeks of gestational age |
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| Secondary | Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation | Sexual transmitted disease included Treponema pallidum, Neisseria gonorrhoeae, and Chlamydia trachomatis infections. This was diagnosed based on clinical presentation prior to Week 36-38 and/or lab test results between Week 36-38. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. | Posted | Number | 95% Confidence Interval | Percentage of participants | Upto 36-38 weeks of gestation |
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| Secondary | Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation | Participants positive for Chlamydia trachomatis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with lab test results at 36-38 weeks of gestation. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 36-38 weeks of gestation |
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| Secondary | Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation | Participants positive for Neisseria gonorrhoeae infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 36-38 weeks of gestation |
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| Secondary | Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation | Participants positive for Treponema pallidum infection was diagnosed based on laboratory result at 36-38 weeks of gestation. Treponema Pallidum particle Agglutination Assay was used. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 36-38 weeks of gestation |
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| Secondary | Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation | Participants positive for Trichomonas vaginalis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the laboratory test. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 36-38 weeks of gestation |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation. | Bacterial vaginosis was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the Gram staining. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 36-38 weeks of gestation |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Neonates With Ophthalmia Neonatorum at Birth Period | Ophthalmia neonatorum was diagnosed at birth. The laboratory diagnosis was performed among neonates with purulent discharge. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Total live births. | Posted | Number | 95% Confidence Interval | Percentage of neonates | Approximately 40 weeks of gestational age |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery | Participants positive for bacterial infections including other lower respiratory tract infections were measured anytime from first dose administration to delivery. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with available data. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 40 weeks of gestational age |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Pre-eclampsia From Week 20 to Delivery | Pre-eclampsia was diagnosed as systolic blood pressure of at least 140 mmHg and/or diastolic blood pressure of at least 90 mmHg on two separate readings taken at least 4 hours apart and proteinuria at least 300 mg protein in a 24 hour urine collection. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N= Number of participants with available data. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Week 20 to approximately 40 weeks of gestational age |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae | This outcome measure evaluated the Streptococcus pneumoniae sensitivity against macrolide antibiotics. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participant with nasopharyngeal swabs isolating Streptococcus pneumoniae at the specified visit. | Posted | Number | Percentage of participants | Visits 6 and 7 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae | This outcome measure evaluated the Streptococcus pneumoniae sensitivity against penicillin antibiotics. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participant with nasopharyngeal swabs isolating Streptococcus pneumoniae at the specified visit. | Posted | Number | Percentage of participants | Visits 6 and 7 |
|
Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Some events are seen only in neonates (e.g neonatal malformation/anomalies, LBW etc.) and are not expected in mothers and vice versa. Such events are designated as 'zero' in the respective 'familial status- neonate/mother' in the below table.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mother (Azithromycin + Chloroquine) | The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals. | 65 | 1,446 | 1,177 | 1,446 | ||
| EG001 | Mother (Sulfadoxine + Pyrimethamine) | The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals. | 42 | 1,445 | 888 | 1,445 | ||
| EG002 | Neonate (Azithromycin + Chloroquine) | Live births of participants who received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals. | 101 | 1,149 | 301 | 1,149 | ||
| EG003 | Neonate (Sulfadoxine + Pyrimethamine) | Live births of participants who received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals. | 104 | 1,196 | 326 | 1,196 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Haemorrhagic disease of newborn | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Tricuspid valve disease | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anal atresia | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cerebellar hypoplasia | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Congenital hand malformation | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Congenital malaria | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Congenital umbilical hernia | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cystic lymphangioma | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dysmorphism | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Exomphalos | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Heart disease congenital | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypospadias | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Microgenia | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Polydactyly | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Talipes | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Necrotising colitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Rectourethral fistula | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Death neonatal | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Bartholin's abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Neonatal infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sepsis neonatal | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Uterine rupture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Apgar score low | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| HIV test positive | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Metabolic disorder | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Abortion spontaneous complete | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Foetal distress syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| HELLP syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Haemorrhage in pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Imminent abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Low birth weight baby | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Neonatal disorder | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Obstructed labour | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Placental disorder | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Placental infarction | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Premature delivery | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Preterm premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Threatened labour | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Umbilical cord around neck | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Renal vessel disorder | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Acquired phimosis | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neonatal asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neonatal aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Infection parasitic | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sepsis neonatal | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Trichomoniasis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Perineal injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Low birth weight baby | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
This program was terminated by Pfizer based on the results of the pre-planned interim analysis for this pivotal study. The interim analysis showed no benefit of the study drug (AZCQ) compared to standard of care (SP).
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D002738 | Chloroquine |
| C001205 | fanasil, pyrimethamine drug combination |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
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