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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Bill and Melinda Gates Foundation | OTHER |
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This will be a double-blinded randomized controlled phase III trial of 782 HIV uninfected pregnant women and the children born to them. HIV uninfected women at 12-20 weeks gestation will be randomized in equal proportions to one of two intermittent preventive treatment in pregnancy (IPTp) treatment arms: 1) monthly sulfadoxine-pyrimethamine (SP), or 2) monthly dihydroartemisinin-piperaquine (DP). Both interventions arms will have either SP or DP placebo to ensure adequate blinding is achieved in the study. Follow-up for the pregnant women will end approximately 6 weeks after giving birth. All children born to mothers enrolled in the study will be followed from birth until they reach 12 months of age.
Pregnant women will be scheduled to be seen in the clinic every 4 weeks during their pregnancy and then 1 and 6 weeks following delivery. In addition, pregnant women will be instructed to come to the study clinic for all their medical care and avoid the use of any outside medications. Children will be scheduled to be seen in the clinic at 1, 4, 6, and 8 weeks of age and then every 4 weeks until they reach 52 weeks of age. Parents/guardians will be instructed to bring their children to the study clinic for all medical care and avoid the use of any outside medications. The study clinic will remain open 7 days a week from 8 a.m. to 5 p.m. Study participants not seen in the clinic for their every 4 week routine visits will be visited at home and requested to come to the study clinic as soon as possible. Pregnant women and children will receive standard of care as designated in the Uganda Ministry of Health guidelines. Routine antenatal care will include screening and treatment for sexually transmitted infections, blood pressure assessment, urine dipstick for proteinuria, prescription of iron, folate, multivitamins and mebendazole. Routine care in children will include immunizations, vitamin A supplementation, and management of anemia using Integrated Management of Childhood Illness (IMCI) guidelines. During routine assessments subjects will be asked about visits to outside health facilities and the use of any medications outside the study protocol. Standardized assessment of adherence will be done for study drugs administered at home and insecticide treated net use. A routine history and physical exam will be performed using a standardized clinical assessment form. Blood will be collected by finger prick for thick smear (in very young children, heel sticks may be substituted for finger pricks), capillary plasma (for routine visits where phlebotomy is not done in pregnant women only) and filter paper samples. If a pregnant woman or parent/guardian of a child reports a fever in the last 24 hours or the patient has a documented temperature > 38.0ËšC tympanic, the patient's thick blood smear will be read immediately and if positive the patient will be diagnosed and treated for malaria. If the thick blood smear is negative, the patient will be managed by study physicians for a non-malarial febrile illness. If the patient is afebrile and does not report a recent fever, a thick blood smear will not be obtained, except when following routine testing schedules. In pregnant mothers, thick blood smears other than those done when a mother has fever will not be used for clinical care of study participants. Phlebotomy for routine laboratory tests (CBC and ALT) to monitor for potential adverse events from study medications, storage of plasma and for immunology studies will be performed every 8 weeks in pregnant women. Phlebotomy for routine laboratory tests (CBC) and immunology studies will be performed at 12, 28, and 52 weeks of age in children. For pregnant women, study drugs will be administered at the time of each routine visit. ECGs will be performed to measure the QTc interval in all pregnant women just prior to the 1st dose of study drugs and 2-3 hours after their 3rd dose of study drugs at 20, 28 and 36 weeks of gestation. In addition a finger prick capillary plasma sample will be collected just prior to performing the ECGs after the 3rd dose of study drugs at 20, 28, and 36 weeks of gestation in pregnant women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy | Active Comparator | Women will be given SP (3 full strength tabs, 500 mg/25 mg) every four weeks times during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two drugs on day 1 (SP and placebo or DP and placebo) followed by one drug on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. |
|
| Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy | Active Comparator | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two drugs on day 1 (SP and placebo or DP and placebo) followed by one drug on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Deliver With a Composite Adverse Birth Outcome | Composite adverse birth outcome defined as any one of the following: 1) Low birth weight (< 2500 gm); 2) Preterm delivery (< 37 weeks gestational age); 3) Small for gestational age (< 10th percentile relative to an external growth reference) | Delivery |
| Incidence of Malaria in Infants | episodes per person year | Time at risk will begin at birth and end when study participants reaches 12 months of age or early study termination |
| Mean Gestational Age in Weeks at Birth | Gestational age in weeks determined by ultrasound dating (gold standard) and by the metabolic profiling outcome from biological specimens including placental tissue and placental blood. | At the time of delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Placental Malaria by Histology | Any evidence of placental infection (parasites or pigment). Number of participants with placental tissue positive for malaria parasites or pigment. | Delivery |
| Prevalence of Placental Parasitemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grant Dorsey, MD PhD | University of California, San Francisco | Principal Investigator |
| Diane V Havlir, MD | University of California, San Francisco | Principal Investigator |
| Moses Kamya, MBChB MMed PhD | Makarere Univeritys ; Infectious Disease Research Collaboration | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IDRC - Tororo Research Clinic | Tororo | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30910321 | Result | Kajubi R, Ochieng T, Kakuru A, Jagannathan P, Nakalembe M, Ruel T, Opira B, Ochokoru H, Ategeka J, Nayebare P, Clark TD, Havlir DV, Kamya MR, Dorsey G. Monthly sulfadoxine-pyrimethamine versus dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria in pregnancy: a double-blind, randomised, controlled, superiority trial. Lancet. 2019 Apr 6;393(10179):1428-1439. doi: 10.1016/S0140-6736(18)32224-4. Epub 2019 Mar 22. | |
| 30019470 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy | Women will be given SP (3 full strength tabs, 500 mg/25 mg) every four weeks times during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two drugs on day 1 (SP and placebo or DP and placebo) followed by one drug on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy |
| FG001 | Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two drugs on day 1 (SP and placebo or DP and placebo) followed by one drug on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy | Women will be given SP (3 full strength tabs, 500 mg/25 mg) every four weeks times during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two drugs on day 1 (SP and placebo or DP and placebo) followed by one drug on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Deliver With a Composite Adverse Birth Outcome | Composite adverse birth outcome defined as any one of the following: 1) Low birth weight (< 2500 gm); 2) Preterm delivery (< 37 weeks gestational age); 3) Small for gestational age (< 10th percentile relative to an external growth reference) | Number of livebirths reported here. SP: 338 women followed through delivery resulting in 348 infants (10 twin sets). 9 mothers/infants excluded (4 spontaneous abortions, 5 stillbirths). DP: 349 women followed through delivery resulting in 352 infants (3 twin sets). 12 mothers and 13 infants excluded (10 spontaneous abortions, 3 stillbirths). | Posted | Count of Participants | Participants | Delivery |
|
Adverse event data were collected following the initiation of study drugs through to 6 weeks postpartum.
Adverse events were assessed and graded according to standardized criteria (National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0) at every visit to the study clinic.
The number of participants at risk are all women that were enrolled, randomized, AND received at least 1 dose of study drugs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy | Women will be given SP (3 full strength tabs, 500 mg/25 mg) every four weeks times during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two drugs on day 1 (SP and placebo or DP and placebo) followed by one drug on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grant Dorsey, MD | University of California, San Francisco | 628-206-4680 | grant.dorsey@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 27, 2018 | Sep 2, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy | Drug |
|
|
Proportion of placental blood samples positive for parasites by Loop-mediated isothermal amplification (LAMP) or microscopy
| Delivery |
| Prevalence of Maternal Malaria | Maternal blood positive for malaria parasites by microscopy. | Gestational age between 12-20 weeks (at study entry) up to delivery |
| Number of Participants With Adverse Events | All grade 3 and 4 adverse events | Starting at the time of their first study drug administration, approximately gestational age between 12-20 weeks, up to one month post-delivery |
| Prevalence of Anemia in Pregnant Women | hemoglobin < 11 g/dL | Starting at the time of their first study drug administration, approximately gestational age between 12-20 weeks, up to one month post-delivery |
| Prevalence of Anemia in Infants | Defined as the proportion with hemoglobin < 10 g/dL measure routinely at 12, 28, and 52 weeks of age. Number of cases per person year (PPY). This is a prevalence measure but are repeated measures during infancy. In other words we measured this outcome up to 3 times for each participant during infancy (at 12, 28 and 52 weeks of age). | Birth up to 12 months of age or early termination |
| Prevalence of Asymptomatic Parasitemia in Pregnant Women | Proportion of routine monthly samples positive for parasites by microscopy and LAMP | Starting at the time of their first study drug administration, approximately gestational age between 12-20 weeks, up to one month post-delivery |
| Prevalence of Asymptomatic Parasitemia in Infants | Proportion of routine monthly samples positive for parasites by microscopy and LAMP | Birth up to 12 months of age or early termination |
| Incidence of Complicated Malaria in Infants | Complicated malaria defined as an episode of malaria with danger signs (any of the following: less than 3 convulsions over 24 h, inability to sit or stand, vomiting everything, unable to breastfeed or drink) or the meeting standardized criteria for severe malaria. | Birth up to 12 months of age or early termination |
| Incidence of Hospital Admissions in Infants | Admission to the pediatric ward for any cause | Birth up to 12 months of age or early termination |
| Infant Mortality Rate | Any deaths occurring after birth | Birth up to 12 months of age |
| Result |
| Harrington WE, Kakuru A, Jagannathan P. Malaria in pregnancy shapes the development of foetal and infant immunity. Parasite Immunol. 2019 Mar;41(3):e12573. doi: 10.1111/pim.12573. Epub 2018 Aug 28. |
| 30891605 | Result | Briggs J, Ategeka J, Kajubi R, Ochieng T, Kakuru A, Ssemanda C, Wasswa R, Jagannathan P, Greenhouse B, Rodriguez-Barraquer I, Kamya M, Dorsey G. Impact of Microscopic and Submicroscopic Parasitemia During Pregnancy on Placental Malaria in a High-Transmission Setting in Uganda. J Infect Dis. 2019 Jul 2;220(3):457-466. doi: 10.1093/infdis/jiz130. |
| 31014336 | Result | Okiring J, Olwoch P, Kakuru A, Okou J, Ochokoru H, Ochieng TA, Kajubi R, Kamya MR, Dorsey G, Tusting LS. Household and maternal risk factors for malaria in pregnancy in a highly endemic area of Uganda: a prospective cohort study. Malar J. 2019 Apr 23;18(1):144. doi: 10.1186/s12936-019-2779-x. |
| 32772921 | Result | Kakuru A, Jagannathan P, Kajubi R, Ochieng T, Ochokoru H, Nakalembe M, Clark TD, Ruel T, Staedke SG, Chandramohan D, Havlir DV, Kamya MR, Dorsey G. Impact of intermittent preventive treatment of malaria in pregnancy with dihydroartemisinin-piperaquine versus sulfadoxine-pyrimethamine on the incidence of malaria in infancy: a randomized controlled trial. BMC Med. 2020 Aug 10;18(1):207. doi: 10.1186/s12916-020-01675-x. |
| 29547881 | Result | Savic RM, Jagannathan P, Kajubi R, Huang L, Zhang N, Were M, Kakuru A, Muhindo MK, Mwebaza N, Wallender E, Clark TD, Opira B, Kamya M, Havlir DV, Rosenthal PJ, Dorsey G, Aweeka FT. Intermittent Preventive Treatment for Malaria in Pregnancy: Optimization of Target Concentrations of Dihydroartemisinin-Piperaquine. Clin Infect Dis. 2018 Sep 14;67(7):1079-1088. doi: 10.1093/cid/ciy218. |
| 32249917 | Result | Ategeka J, Kakuru A, Kajubi R, Wasswa R, Ochokoru H, Arinaitwe E, Yeka A, Jagannathan P, Kamya MR, Muehlenbachs A, Chico RM, Dorsey G. Relationships Between Measures of Malaria at Delivery and Adverse Birth Outcomes in a High-Transmission Area of Uganda. J Infect Dis. 2020 Aug 4;222(5):863-870. doi: 10.1093/infdis/jiaa156. |
| 32562650 | Result | Roh ME, Kuile FOT, Rerolle F, Glymour MM, Shiboski S, Gosling R, Gutman J, Kakuru A, Desai M, Kajubi R, L'Ianziva A, Kamya MR, Dorsey G, Chico RM. Overall, anti-malarial, and non-malarial effect of intermittent preventive treatment during pregnancy with sulfadoxine-pyrimethamine on birthweight: a mediation analysis. Lancet Glob Health. 2020 Jul;8(7):e942-e953. doi: 10.1016/S2214-109X(20)30119-4. |
| 35876164 | Derived | Vaaben AV, Levan J, Nguyen CBT, Callaway PC, Prahl M, Warrier L, Nankya F, Musinguzi K, Kakuru A, Muhindo MK, Dorsey G, Kamya MR, Feeney ME. In Utero Activation of Natural Killer Cells in Congenital Cytomegalovirus Infection. J Infect Dis. 2022 Sep 4;226(4):566-575. doi: 10.1093/infdis/jiac307. |
| 34864925 | Derived | Hughes E, Wallender E, Kajubi R, Jagannathan P, Ochieng T, Kakuru A, Kamya MR, Clark TD, Rosenthal PJ, Dorsey G, Aweeka F, Savic RM. Piperaquine-Induced QTc Prolongation Decreases With Repeated Monthly Dihydroartemisinin-Piperaquine Dosing in Pregnant Ugandan Women. Clin Infect Dis. 2022 Aug 31;75(3):406-415. doi: 10.1093/cid/ciab965. |
| 33738485 | Derived | Zehner N, Adrama H, Kakuru A, Andra T, Kajubi R, Conrad M, Nankya F, Clark TD, Kamya M, Rodriguez-Barraquer I, Dorsey G, Jagannathan P. Age-Related Changes in Malaria Clinical Phenotypes During Infancy Are Modified by Sickle Cell Trait. Clin Infect Dis. 2021 Nov 16;73(10):1887-1895. doi: 10.1093/cid/ciab245. |
| 33272281 | Derived | Kakuru A, Roh ME, Kajubi R, Ochieng T, Ategeka J, Ochokoru H, Nakalembe M, Clark TD, Ruel T, Staedke SG, Chandramohan D, Havlir DV, Kamya MR, Dorsey G, Jagannathan P. Infant sex modifies associations between placental malaria and risk of malaria in infancy. Malar J. 2020 Dec 3;19(1):449. doi: 10.1186/s12936-020-03522-z. |
| Adverse Event |
|
| Protocol Violation |
|
| BG001 | Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two drugs on day 1 (SP and placebo or DP and placebo) followed by one drug on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gestational age category (weeks) | Count of Participants | Participants |
|
| Detection of malaria parasites by microscopy or qPCR | Count of Participants | Participants |
|
| OG001 | Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two drugs on day 1 (SP and placebo or DP and placebo) followed by one drug on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy |
|
|
| Primary | Incidence of Malaria in Infants | episodes per person year | 339 live births included in the analyses for both groups. | Posted | Number | episodes per person year | Time at risk will begin at birth and end when study participants reaches 12 months of age or early study termination |
|
|
|
| Primary | Mean Gestational Age in Weeks at Birth | Gestational age in weeks determined by ultrasound dating (gold standard) and by the metabolic profiling outcome from biological specimens including placental tissue and placental blood. | 339 live births included in the analyses for both groups. | Posted | Mean | Standard Deviation | weeks | At the time of delivery |
|
|
|
| Secondary | Prevalence of Placental Malaria by Histology | Any evidence of placental infection (parasites or pigment). Number of participants with placental tissue positive for malaria parasites or pigment. | analysis population is women who delivered and had histopathology results (i.e. some women who delivered did not have histopathology results) | Posted | Count of Participants | Participants | Delivery |
|
|
|
| Secondary | Prevalence of Placental Parasitemia | Proportion of placental blood samples positive for parasites by Loop-mediated isothermal amplification (LAMP) or microscopy | LAMP and microscopy performed for the number of participants reported in each group. | Posted | Count of Participants | Participants | Delivery |
|
|
|
| Secondary | Prevalence of Maternal Malaria | Maternal blood positive for malaria parasites by microscopy. | Posted | Count of Participants | Participants | Gestational age between 12-20 weeks (at study entry) up to delivery |
|
|
|
| Secondary | Number of Participants With Adverse Events | All grade 3 and 4 adverse events | Posted | Count of Participants | Participants | Starting at the time of their first study drug administration, approximately gestational age between 12-20 weeks, up to one month post-delivery |
|
|
|
| Secondary | Prevalence of Anemia in Pregnant Women | hemoglobin < 11 g/dL | Number of women initiated on study drugs reported here. | Posted | Count of Participants | Participants | Starting at the time of their first study drug administration, approximately gestational age between 12-20 weeks, up to one month post-delivery |
|
|
|
| Secondary | Prevalence of Anemia in Infants | Defined as the proportion with hemoglobin < 10 g/dL measure routinely at 12, 28, and 52 weeks of age. Number of cases per person year (PPY). This is a prevalence measure but are repeated measures during infancy. In other words we measured this outcome up to 3 times for each participant during infancy (at 12, 28 and 52 weeks of age). | 339 live births included in the analyses for both groups. | Posted | Count of Units | routine hemoglobin measurement | Birth up to 12 months of age or early termination | routine hemoglobin measurement | routine hemoglobin measurement |
|
|
|
| Secondary | Prevalence of Asymptomatic Parasitemia in Pregnant Women | Proportion of routine monthly samples positive for parasites by microscopy and LAMP | Posted | Count of Units | blood smears | Starting at the time of their first study drug administration, approximately gestational age between 12-20 weeks, up to one month post-delivery | blood smears | blood smears |
|
|
|
| Secondary | Prevalence of Asymptomatic Parasitemia in Infants | Proportion of routine monthly samples positive for parasites by microscopy and LAMP | Posted | Count of Units | blood smears | Birth up to 12 months of age or early termination | blood smears | blood smears |
|
|
|
| Secondary | Incidence of Complicated Malaria in Infants | Complicated malaria defined as an episode of malaria with danger signs (any of the following: less than 3 convulsions over 24 h, inability to sit or stand, vomiting everything, unable to breastfeed or drink) or the meeting standardized criteria for severe malaria. | 339 live births included in the analyses for both groups. | Posted | Count of Participants | Participants | Birth up to 12 months of age or early termination |
|
|
|
| Secondary | Incidence of Hospital Admissions in Infants | Admission to the pediatric ward for any cause | 339 live births included in the analyses for both groups. | Posted | Count of Participants | Participants | Birth up to 12 months of age or early termination |
|
|
|
| Secondary | Infant Mortality Rate | Any deaths occurring after birth | 339 live births included in the analyses for both groups. | Posted | Count of Participants | Participants | Birth up to 12 months of age |
|
|
|
| 1 |
| 375 |
| 11 |
| 375 |
| 341 |
| 375 |
| EG001 | Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two drugs on day 1 (SP and placebo or DP and placebo) followed by one drug on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy | 3 | 373 | 19 | 373 | 341 | 373 |
| Congenital anomaly | Congenital, familial and genetic disorders | Systematic Assessment | Birthed infant with congenital anomaly |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Elevated Alanine Aminotransferase | Blood and lymphatic system disorders | Systematic Assessment |
|
| Altered mental status | Psychiatric disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Haemorrhage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Cough | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Pyuria | Renal and urinary disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D000079426 |
| Vector Borne Diseases |
| Microscopy |
|
|