Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P01HD059454 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This will be a double-blinded randomized controlled phase III trial of 300 HIV uninfected pregnant women and the children born to them. The study interventions will be divided into two phases. In the first phase, HIV uninfected women at 12-20 weeks gestation will be randomized in equal proportions to one of three intermittent preventive therapy in pregnancy (IPTp) treatment arms: 1) 3 doses of sulfadoxine-pyrimethamine (SP), 2) 3 doses of dihydroartemisinin-piperaquine (DP), or 3) monthly DP. All three interventions arms will have either SP or DP placebo to ensure adequate blinding is achieved. Follow-up for the pregnant women will end approximately 6 weeks after giving birth. In the second phase of the study, all children born to mothers enrolled in the study will be followed from birth until they reach 36 months of age. Children born to mothers randomized to receive 3 doses of SP during pregnancy will receive DP every 3 months between 2-24 months of age. Children born to mothers randomized to receive 3 doses of DP or monthly DP during pregnancy will receive either DP every 3 months or monthly DP between 2-24 months of age. To ensure adequate blinding, children who will receive DP every 3 months will be given DP placebo during the months they will not be taking DP. Children will then be followed an additional year between 24-36 months of age following the interventions. We will test the hypothesis that IPT with DP will significantly reduce the burden of malaria in pregnancy and infancy and improve the development of naturally acquired antimalarial immunity.
Pregnant women will be scheduled to be seen in the clinic every 4 weeks during their pregnancy 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 every 4 weeks and parents /guardians of children will be instructed to bring their child 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.
Each time a study participant is seen in the clinic a standardized history and physical exam will be performed. Patients who are febrile (tympanic temperature > 3 8.0ËšC) or report history of fever in the past 24 hours will have blood obtained by finger prick for a thick blood smear. If the thick blood smear is positive, the patient will be diagnosed with 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.
Routine assessments will be done in the clinic every 4 weeks for both pregnant women and children. Pregnant women and children will receive standards of care as designated in the Uganda MOH guidelines. Routine care in children will use 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 also 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, collection of plasma for PK studies, and filter paper samples. Phlebotomy for routine laboratory tests (CBC and ALT) to monitor for potential adverse events from study medications and for immunology studies will be performed every 8 weeks in pregnant women and every 16 weeks in children. Non malaria screening will also include stool ova and parasite examination, circulating filarial antigens (by ICT card for Wucheria), and blood smear for microfilaremia (including Mansonella perstans) using Knott's technique. For pregnant women and children 2-24 months of age, study drugs will be administered at the time of each routine visit.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 dose SP pregnancy / 3 monthly DP infancy | Active Comparator | Women will be given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. |
|
| 3 dose DP pregnancy / 3 monthly DP infancy | Active Comparator | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. |
|
| 3 dose DP pregnancy / monthly DP infancy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Placental Malaria | Prevalence of placental malaria based on placental histopathology dichotomized into any evidence of placental infection (parasites or pigment) vs. no evidence and by histopathology as a categorical variable based on Rogerson et al criteria. | Delivery |
| Incidence of Malaria in Pregnant Women | Incidence of malaria, defined as the number of incident episodes per time at risk. Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. | Time at risk will begin after first dose of study drug and will end when study participants deliver or early study termination |
| Incidence of Malaria in Infants | Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. The study investigators will test the hypotheses that A) infants born to mothers randomized to receive IPTp with 3 dose DP or monthly DP will have a lower incidence of malaria during the first 24 months of life compared to infants born to mothers who were randomized to receive IPTp with 3 doses of SP, and, B) infants randomized to receive monthly DP between 2-24 months of age will have a lower incidence of malaria between 24-36 months of age after the intervention is stopped compared to infants randomized q 3 monthly DP between 2-24 months of age. | Time at risk will begin at birth and will end when study participants reaches 24 months of age or early study termination (if prior to 24 months of age) |
| Incidence of Malaria in Infants | Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. The study investigators will test the hypotheses that A) infants born to mothers randomized to receive IPTp with 3 dose DP or monthly DP will have a lower incidence of malaria during the first 24 months of life compared to infants born to mothers who were randomized to receive IPTp with 3 doses of SP, and, B) infants randomized to receive monthly DP between 2-24 months of age will have a lower incidence of malaria between 24-36 months of age after the intervention is stopped compared to infants randomized q 3 monthly DP between 2-24 months of age. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Blood Samples Positive for Parasites by Microscopy or LAMP | Prevalence of placental blood samples positive for parasites by microscopy or LAMP | Delivery |
| Number of Participants With Maternal Blood Samples Positive for Parasites by Microscopy and LAMP at Delivery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Makerere University; Infectious Diseases Research Collaboration | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IDRC Research Clinic -Tororo District Hospital | Tororo | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26962728 | Result | Kakuru A, Jagannathan P, Muhindo MK, Natureeba P, Awori P, Nakalembe M, Opira B, Olwoch P, Ategeka J, Nayebare P, Clark TD, Feeney ME, Charlebois ED, Rizzuto G, Muehlenbachs A, Havlir DV, Kamya MR, Dorsey G. Dihydroartemisinin-Piperaquine for the Prevention of Malaria in Pregnancy. N Engl J Med. 2016 Mar 10;374(10):928-39. doi: 10.1056/NEJMoa1509150. | |
| 27566109 | Result | Muhindo MK, Kakuru A, Natureeba P, Awori P, Olwoch P, Ategeka J, Nayebare P, Clark TD, Muehlenbachs A, Roh M, Mpeka B, Greenhouse B, Havlir DV, Kamya MR, Dorsey G, Jagannathan P. Reductions in malaria in pregnancy and adverse birth outcomes following indoor residual spraying of insecticide in Uganda. Malar J. 2016 Aug 26;15(1):437. doi: 10.1186/s12936-016-1489-x. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mothers - 3 Dose SP | Sulfadoxine-Pyrimethamine 500mg/25mg |
| FG001 | Mothers - 3 Dose DP | Dihydrioartemisinin-Piperaquine 40mg/320mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 25, 2017 | Aug 16, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Active Comparator |
Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. |
|
| monthly DP pregnancy / 3 monthly DP infancy | 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 pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. |
|
| monthly DP pregnancy / monthly DP infancy | 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 pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. |
|
| 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy | Drug |
|
|
| 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy | Drug |
|
|
| Monthly dihydroartemisinin-piperaquine (DP) for infants | Drug |
|
|
| 3-monthly dihydroartemisinin-piperaquine (DP) for infants | Drug |
|
|
| Time at risk will begin at 24 months of age and will end when study participants reaches 36 months of age or termination |
Prevalence of maternal parasitemia at delivery by microscopy and LAMP |
| At delivery |
| Number of Participants With One or More Birth Outcomes: Congenital Malformations, Spontaneous Abortion, LBW (<2500g), Still Birth, Pre-term Delivery | Congenital malformations, spontaneous abortion, LBW (<2500g), still birth, pre-term delivery | Delivery |
| Prevalence of Anemia in Pregnant Women | Prevalence of routine hemoglobin measurements < 11 g/dL | After first dose of study drugs up to delivery or early termination |
| Incidence of Complicated Malaria in Infants | Any treatment for malaria meeting criteria for severe malaria or danger signs | Birth up to 24 months of age or early study termination |
| Incidence of Hospital Admissions in Infants | Admission to a hospital for pediatric inpatient care for any reason | Birth up to 24 months of age or early study termination |
| Prevalence of Gametocytemia in Pregnant Women | Proportion of urgent blood smears positive for gametocytes | Gestational age between 12-20 weeks (at study entry) up to delivery |
| Prevalence of Parasitemia in Infants | Proportion of routine monthly samples positive for parasites by LAMP. Proportion of routine samples (LAMP or blood smears) positive for asexual parasites. | Birth up to 24 months of age or early study termination |
| Prevalence of Parasitemia at the Time of Monthly Routine Visits During Pregnancy | Detection of malaria parasites by LAMP during pregnancy | After first dose of study drug through delivery or early termination |
| Prevalence of Gametocytemia in Infants | Proportion of routine blood smears positive for gametocytes | Birth up to 24 months of age or early study termination |
| 28968782 | Result | Conrad MD, Mota D, Foster M, Tukwasibwe S, Legac J, Tumwebaze P, Whalen M, Kakuru A, Nayebare P, Wallender E, Havlir DV, Jagannathan P, Huang L, Aweeka F, Kamya MR, Dorsey G, Rosenthal PJ. Impact of Intermittent Preventive Treatment During Pregnancy on Plasmodium falciparum Drug Resistance-Mediating Polymorphisms in Uganda. J Infect Dis. 2017 Nov 15;216(8):1008-1017. doi: 10.1093/infdis/jix421. |
| 28982374 | Result | Kapisi J, Kakuru A, Jagannathan P, Muhindo MK, Natureeba P, Awori P, Nakalembe M, Ssekitoleko R, Olwoch P, Ategeka J, Nayebare P, Clark TD, Rizzuto G, Muehlenbachs A, Havlir DV, Kamya MR, Dorsey G, Gaw SL. Relationships between infection with Plasmodium falciparum during pregnancy, measures of placental malaria, and adverse birth outcomes. Malar J. 2017 Oct 5;16(1):400. doi: 10.1186/s12936-017-2040-4. |
| 30016328 | Result | Jagannathan P, Kakuru A, Okiring J, Muhindo MK, Natureeba P, Nakalembe M, Opira B, Olwoch P, Nankya F, Ssewanyana I, Tetteh K, Drakeley C, Beeson J, Reiling L, Clark TD, Rodriguez-Barraquer I, Greenhouse B, Wallender E, Aweeka F, Prahl M, Charlebois ED, Feeney ME, Havlir DV, Kamya MR, Dorsey G. Dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria during pregnancy and risk of malaria in early childhood: A randomized controlled trial. PLoS Med. 2018 Jul 17;15(7):e1002606. doi: 10.1371/journal.pmed.1002606. eCollection 2018 Jul. |
| 31307883 | Result | Muhindo MK, Jagannathan P, Kakuru A, Opira B, Olwoch P, Okiring J, Nalugo N, Clark TD, Ruel T, Charlebois E, Feeney ME, Havlir DV, Dorsey G, Kamya MR. Intermittent preventive treatment with dihydroartemisinin-piperaquine and risk of malaria following cessation in young Ugandan children: a double-blind, randomised, controlled trial. Lancet Infect Dis. 2019 Sep;19(9):962-972. doi: 10.1016/S1473-3099(19)30299-3. Epub 2019 Jul 12. |
| 30628574 | Result | Conroy AL, Bangirana P, Muhindo MK, Kakuru A, Jagannathan P, Opoka RO, Liechty EA, Nakalembe M, Kamya MR, Dorsey G, John CC. Case Report: Birth Outcome and Neurodevelopment in Placental Malaria Discordant Twins. Am J Trop Med Hyg. 2019 Mar;100(3):552-555. doi: 10.4269/ajtmh.18-0659. |
| 34795281 | Derived | Wallender E, Ali AM, Hughes E, Kakuru A, Jagannathan P, Muhindo MK, Opira B, Whalen M, Huang L, Duvalsaint M, Legac J, Kamya MR, Dorsey G, Aweeka F, Rosenthal PJ, Savic RM. Identifying an optimal dihydroartemisinin-piperaquine dosing regimen for malaria prevention in young Ugandan children. Nat Commun. 2021 Nov 18;12(1):6714. doi: 10.1038/s41467-021-27051-8. |
| 33020153 | Derived | Hughes E, Imperial M, Wallender E, Kajubi R, Huang L, Jagannathan P, Zhang N, Kakuru A, Natureeba P, Mwima MW, Muhindo M, Mwebaza N, Clark TD, Opira B, Nakalembe M, Havlir D, Kamya M, Rosenthal PJ, Dorsey G, Aweeka F, Savic RM. Piperaquine Exposure Is Altered by Pregnancy, HIV, and Nutritional Status in Ugandan Women. Antimicrob Agents Chemother. 2020 Nov 17;64(12):e01013-20. doi: 10.1128/AAC.01013-20. Print 2020 Nov 17. |
| 31173649 | Derived | Whalen ME, Kajubi R, Chamankhah N, Huang L, Orukan F, Wallender E, Kamya MR, Dorsey G, Jagannathan P, Rosenthal PJ, Mwebaza N, Aweeka FT. Reduced Exposure to Piperaquine, Compared to Adults, in Young Children Receiving Dihydroartemisinin-Piperaquine as Malaria Chemoprevention. Clin Pharmacol Ther. 2019 Dec;106(6):1310-1318. doi: 10.1002/cpt.1534. Epub 2019 Jul 22. |
| 29547881 | Derived | 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. |
| FG002 | Mothers - Monthly DP | Dihydroartemisinin-Piperaquine 20mg/160mg |
| Infants Born |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mothers - 3 Dose SP | Sulfadoxine-Pyrimethamine 500mg/25mg |
| BG001 | Mothers - 3 Dose DP | Dihydrioartemisinin-Piperaquine 40mg/320mg |
| BG002 | Mothers - Monthly DP | Dihydroartemisinin-Piperaquine 20mg/160mg |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Gestation (weeks) | Count of Participants | Participants |
| ||||||||||||||||
| Gravidity | Count of Participants | Participants |
| ||||||||||||||||
| Bed-net ownership | Count of Participants | Participants |
| ||||||||||||||||
| Household wealth index | Count of Participants | Participants |
| ||||||||||||||||
| Weight (kg) | Mean | Standard Deviation | kg |
| |||||||||||||||
| Height (cm) | Mean | Standard Deviation | cm |
| |||||||||||||||
| White blood cells per mm^3 | Mean | Standard Deviation | cells per mm^3 |
| |||||||||||||||
| Neutrophil cells per mm^3 | Mean | Standard Deviation | cells per mm^3 |
| |||||||||||||||
| Platelet cells per mm^3 | Mean | Standard Deviation | cells per mm^3 |
| |||||||||||||||
| Hemoglobin level g/dL | Mean | Standard Deviation | g/DL |
| |||||||||||||||
| Alanine aminotransferase level IU/L | Mean | Standard Deviation | IU/L |
| |||||||||||||||
| Detection of malaria parasites by LAMP | Count of Participants | Participants |
|
| 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 | Prevalence of Placental Malaria | Prevalence of placental malaria based on placental histopathology dichotomized into any evidence of placental infection (parasites or pigment) vs. no evidence and by histopathology as a categorical variable based on Rogerson et al criteria. | Only women who delivered and had histopathology results were analyzed. 2 women in 3 Dose SP and 1 woman in monthly DP arms completed the study but did not have histopathology results. | Posted | Count of Participants | Participants | Delivery |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Incidence of Malaria in Pregnant Women | Incidence of malaria, defined as the number of incident episodes per time at risk. Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. | Posted | Number | events per person years | Time at risk will begin after first dose of study drug and will end when study participants deliver or early study termination |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Incidence of Malaria in Infants | Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. The study investigators will test the hypotheses that A) infants born to mothers randomized to receive IPTp with 3 dose DP or monthly DP will have a lower incidence of malaria during the first 24 months of life compared to infants born to mothers who were randomized to receive IPTp with 3 doses of SP, and, B) infants randomized to receive monthly DP between 2-24 months of age will have a lower incidence of malaria between 24-36 months of age after the intervention is stopped compared to infants randomized q 3 monthly DP between 2-24 months of age. | All live births | Posted | Number | Events per person years | Time at risk will begin at birth and will end when study participants reaches 24 months of age or early study termination (if prior to 24 months of age) |
| ||||||||||||||||||||||||||||||||||
| Primary | Incidence of Malaria in Infants | Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. The study investigators will test the hypotheses that A) infants born to mothers randomized to receive IPTp with 3 dose DP or monthly DP will have a lower incidence of malaria during the first 24 months of life compared to infants born to mothers who were randomized to receive IPTp with 3 doses of SP, and, B) infants randomized to receive monthly DP between 2-24 months of age will have a lower incidence of malaria between 24-36 months of age after the intervention is stopped compared to infants randomized q 3 monthly DP between 2-24 months of age. | All live births | Posted | Number | Events per person years | Time at risk will begin at 24 months of age and will end when study participants reaches 36 months of age or termination |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Blood Samples Positive for Parasites by Microscopy or LAMP | Prevalence of placental blood samples positive for parasites by microscopy or LAMP | Posted | Count of Participants | Participants | Delivery |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Maternal Blood Samples Positive for Parasites by Microscopy and LAMP at Delivery | Prevalence of maternal parasitemia at delivery by microscopy and LAMP | One observation in the monthly DP arm did not have results for microscopy; this outcome measure tests blood taken from the mother's arm (different from outcome measure 4 which tests blood taken from the placenta) | Posted | Number | participants | At delivery |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With One or More Birth Outcomes: Congenital Malformations, Spontaneous Abortion, LBW (<2500g), Still Birth, Pre-term Delivery | Congenital malformations, spontaneous abortion, LBW (<2500g), still birth, pre-term delivery | Posted | Count of Participants | Participants | Delivery |
| |||||||||||||||||||||||||||||||||||
| Secondary | Prevalence of Anemia in Pregnant Women | Prevalence of routine hemoglobin measurements < 11 g/dL | Posted | Number | hemoglobin measurements taken every 12wk | After first dose of study drugs up to delivery or early termination | hemoglobin measurements taken every 12wk | hemoglobin measurements taken every 12wk |
| |||||||||||||||||||||||||||||||||
| Secondary | Incidence of Complicated Malaria in Infants | Any treatment for malaria meeting criteria for severe malaria or danger signs | All live births | Posted | Number | Events per person years | Birth up to 24 months of age or early study termination |
| ||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Hospital Admissions in Infants | Admission to a hospital for pediatric inpatient care for any reason | Posted | Number | Events per person years | Birth up to 24 months of age or early study termination |
| |||||||||||||||||||||||||||||||||||
| Secondary | Prevalence of Gametocytemia in Pregnant Women | Proportion of urgent blood smears positive for gametocytes | Posted | Number | Positive blood smears | Gestational age between 12-20 weeks (at study entry) up to delivery | Blood smears | Blood smears |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Prevalence of Parasitemia in Infants | Proportion of routine monthly samples positive for parasites by LAMP. Proportion of routine samples (LAMP or blood smears) positive for asexual parasites. | Posted | Number | Positive blood smears | Birth up to 24 months of age or early study termination | Blood smears | Blood smears |
| |||||||||||||||||||||||||||||||||
| Secondary | Prevalence of Parasitemia at the Time of Monthly Routine Visits During Pregnancy | Detection of malaria parasites by LAMP during pregnancy | Posted | Number | Positive specimens | After first dose of study drug through delivery or early termination | Specimens | Specimens |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Prevalence of Gametocytemia in Infants | Proportion of routine blood smears positive for gametocytes | Posted | Number | Positive blood smears | Birth up to 24 months of age or early study termination | Blood smears | Blood smears |
|
For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs.
National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
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 | Mothers - 3 Dose SP | Women were given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, DP placebo was used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and DP placebo) followed by one pill on days 2 and 3 (DP placebo). | 0 | 106 | 6 | 106 | 90 | 106 |
| EG001 | Mothers - 3 Dose DP | Women were given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, SP and DP placebos were used to mimic the identical dosing strategy as other arms such that every 4 weeks women will receive two pills on day 1 (DP and SP placebo) followed by one pill on days 2 and 3 (DP placebo). | 0 | 94 | 9 | 94 | 78 | 94 |
| EG002 | Mothers - Monthly DP | Women were given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) monthly. In addition, SP placebo to mimic the identical dosing strategy as other arms such that every 4 weeks women will receive two pills on day 1 (DP and SP placebo) followed by one pill on days 2 and 3 (DP). | 0 | 100 | 3 | 100 | 89 | 100 |
| EG003 | Infants - Monthly DP | DP half-strength tablets given once a day for 3 consecutive days according to weight based guidelines. | 4 | 100 | 9 | 100 | 94 | 100 |
| EG004 | Infants - 3 Monthly DP | DP half-strength tablets given once a day for 3 consecutive days according to weight based guidelines. Infants received placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. | 3 | 191 | 15 | 191 | 183 | 191 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Congenital Anomaly | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Stillbirth | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Threatened Abortion | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Retained products of conception | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Preeclampsia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pyelonephritis | Renal and urinary disorders | Systematic Assessment |
| ||
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Elevated temperature | General disorders | Systematic Assessment |
| ||
| Elevated Alanine Aminotransferase | Renal and urinary disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Intestinal Obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Altered Mental State | Psychiatric disorders | Systematic Assessment |
| ||
| Burns | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Neutropenia | Immune system disorders | Systematic Assessment |
| ||
| Malnutrition | General disorders | Systematic Assessment |
| ||
| Dehydration | General disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | Systematic Assessment |
| ||
| Cough | General disorders | Systematic Assessment |
| ||
| Headache | General disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Malaise | General disorders | Systematic Assessment |
| ||
| Dysphagia | General disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
| ||
| Anorexia | General disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hypotension | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grant Dorsey | UCSF | 415-206-4680 | grant.dorsey@ucsf.edu |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 8, 2015 | Aug 16, 2018 | SAP_000.pdf |
| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C001205 | fanasil, pyrimethamine drug combination |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| > 16 to 20 wk |
|
| 2 |
|
| >= 3 |
|
| Untreated Net |
|
| Long lasting insecticide- treated net |
|
| Middle third |
|
| Highest third |
|
| No |
|
| No sample collected |
|
|
| OG001 | 3 Dose DP Pregnancy / 3 Monthly DP Infancy | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants |
| OG002 | 3 Dose DP Pregnancy / Monthly DP Infancy | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants |
| OG003 | Monthly DP Pregnancy / 3 Monthly DP Infancy | 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 pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants |
| OG004 | Monthly DP Pregnancy / Monthly DP Infancy | 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 pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants |
|
|
| OG001 | 3 Dose DP Pregnancy / 3 Monthly DP Infancy | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants |
| OG002 | 3 Dose DP Pregnancy / Monthly DP Infancy | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants |
| OG003 | Monthly DP Pregnancy / 3 Monthly DP Infancy | 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 pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants |
| OG004 | Monthly DP Pregnancy / Monthly DP Infancy | 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 pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants |
|
|
| OG002 | Mothers - Monthly DP | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants |
|
|
|
| OG002 | Mothers - Monthly DP | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants |
|
|
| OG002 | Mothers - Monthly DP | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants |
|
|
| OG002 | 3 Dose DP Pregnancy / Monthly DP Infancy | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants |
| OG003 | Monthly DP Pregnancy / 3 Monthly DP Infancy | 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 pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants |
| OG004 | Monthly DP Pregnancy / Monthly DP Infancy | 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 pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants |
|
|
| OG002 | 3 Dose DP Pregnancy / Monthly DP Infancy | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants |
| OG003 | Monthly DP Pregnancy / 3 Monthly DP Infancy | 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 pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants |
| OG004 | Monthly DP Pregnancy / Monthly DP Infancy | 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 pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants |
|
|
| Blood smears |
|
|
| OG002 | 3 Dose DP Pregnancy / Monthly DP Infancy | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants |
| OG003 | Monthly DP Pregnancy / 3 Monthly DP Infancy | 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 pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants |
| OG004 | Monthly DP Pregnancy / Monthly DP Infancy | 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 pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants |
|
|
| Specimens |
|
|
| OG002 | 3 Dose DP Pregnancy / Monthly DP Infancy | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants |
| OG003 | Monthly DP Pregnancy / 3 Monthly DP Infancy | 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 pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants |
| OG004 | Monthly DP Pregnancy / Monthly DP Infancy | 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 pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill 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. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants |
|
|