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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02163447 |
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Date of registration:
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05/06/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Reducing the Burden of Malaria in HIV-uninfected Pregnant Women and Infants
PROMOTE-BC1 |
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Scientific title:
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Reducing the Burden of Malaria in HIV-uninfected Pregnant Women and Infants (PROMOTE Birth Cohort 1) |
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Date of first enrolment:
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June 23, 2014 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02163447 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Uganda
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Contacts
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Name:
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Moses Kamya, MBChB, MMed, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Makerere University; Infectious Diseases Research Collaboration |
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Name:
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Diane V Havlir, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Francisco |
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Name:
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Grant Dorsey, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Francisco |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Pregnancy confirmed by positive urine pregnancy test or intrauterine pregnancy by
ultrasound
2. Estimated gestational age between 12-20 weeks
3. Confirmed to be HIV uninfected by rapid test
4. 16 years of age or older
5. Residency within 30km of the study clinic
6. Provision of informed consent by the pregnant woman for herself and her unborn child
7. Agreement to come to the study clinic for any febrile episode or other illness and
avoid medications given outside the study protocol
8. Plan to deliver in the hospital
Exclusion Criteria:
1. History of serious adverse event to SP or DP
2. Active medical problem requiring inpatient evaluation at the time of screening
3. Intention of moving more than 30km from the study clinic
4. Chronic medical condition requiring frequent medical attention
5. Prior SP preventive therapy or any other antimalarial therapy during this pregnancy
6. Early or active labor (documented by cervical change with uterine contractions)
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Malaria
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Intervention(s)
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Drug: 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy
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Drug: 3-monthly dihydroartemisinin-piperaquine (DP) for infants
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Drug: 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy
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Drug: Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy
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Drug: Monthly dihydroartemisinin-piperaquine (DP) for infants
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Primary Outcome(s)
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Incidence of Malaria in Infants
[Time Frame: Time at risk will begin at 24 months of age and will end when study participants reaches 36 months of age or termination]
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Incidence of Malaria in Infants
[Time Frame: 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)]
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Incidence of Malaria in Pregnant Women
[Time Frame: Time at risk will begin after first dose of study drug and will end when study participants deliver or early study termination]
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Prevalence of Placental Malaria
[Time Frame: Delivery]
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Secondary Outcome(s)
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Number of Participants With One or More Birth Outcomes: Congenital Malformations, Spontaneous Abortion, LBW (<2500g), Still Birth, Pre-term Delivery
[Time Frame: Delivery]
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Prevalence of Gametocytemia in Pregnant Women
[Time Frame: Gestational age between 12-20 weeks (at study entry) up to delivery]
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Incidence of Hospital Admissions in Infants
[Time Frame: Birth up to 24 months of age or early study termination]
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Prevalence of Gametocytemia in Infants
[Time Frame: Birth up to 24 months of age or early study termination]
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Prevalence of Parasitemia in Infants
[Time Frame: Birth up to 24 months of age or early study termination]
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Incidence of Complicated Malaria in Infants
[Time Frame: Birth up to 24 months of age or early study termination]
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Number of Participants With Blood Samples Positive for Parasites by Microscopy or LAMP
[Time Frame: Delivery]
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Prevalence of Anemia in Pregnant Women
[Time Frame: After first dose of study drugs up to delivery or early termination]
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Number of Participants With Maternal Blood Samples Positive for Parasites by Microscopy and LAMP at Delivery
[Time Frame: At delivery]
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Prevalence of Parasitemia at the Time of Monthly Routine Visits During Pregnancy
[Time Frame: After first dose of study drug through delivery or early termination]
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Secondary ID(s)
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PROMOTE-BC1
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P01HD059454
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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