Status:
TERMINATED
Chlorproguanil-Dapsone in Pregnant Women
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
Malaria Research and Training Center, Bamako, Mali
Liverpool School of Tropical Medicine
Conditions:
Malaria
Eligibility:
FEMALE
15-49 years
Phase:
PHASE1
Brief Summary
Controlling malaria during pregnancy is a vital strategy in decreasing maternal and child mortality in Africa. There are data from clinical trials and program evaluations in stable transmission areas ...
Detailed Description
Malaria infection during pregnancy poses substantial risk to the mother, her fetus, and the neonate. In areas of stable transmission where adult women have considerable acquired immunity, Plasmodium f...
Eligibility Criteria
Inclusion
- For the pregnancy part of the study, a subject will be considered eligible for inclusion in this study only if all of the following criteria apply: She
- Is pregnant and presents at the antenatal clinic (ANC) facilities of the study hospital.
- Has uncomplicated malaria (either symptomatic or not) with pure (on microscopic grounds) P falciparum parasitemia.
- Has a gestational age of \>= 20 and \< 36 weeks (defined by fundal height).
- Is willing and able to participate and comply with the study protocol, attend the ANCs regularly and agrees to supervised drug delivery.
- Has no history of antimalarial intake in the previous 4 weeks, with the exception of chloroquine or quinine.
- Has given written or witnessed verbal consent.
- For the 66 non-pregnant women, the following inclusion criteria will apply:
- Has uncomplicated malaria (either symptomatic or not) with pure (on microscopic grounds) P falciparum parasitemia.
- Negative urine pregnancy test.
- Is willing and able to participate and comply with the study protocol, attend the ANCs regularly and agrees to supervised drug delivery.
- Has no history of antimalarial intake in the previous 4 weeks, with the exception of chloroquine or quinine.
- Has given written or witnessed verbal consent.
Exclusion
- Any feature of severe malaria.
- A history of convulsions during the present illness.
- Known history of G6PD deficiency or sickle cell disease.
- Other conditions requiring hospitalization or evidence of severe concomitant infection at time of presentation.
- Women on daily cotrimoxazole prophylaxis
- Use of any antimalarial (other than chloroquine or quinine) in the past 4 weeks.
- Known chronic disease (cardiac, renal, hepatic, hemoglobinopathy), or known hepatic or renal impairment.
- Inability to follow the ANC consultation.
- Hemoglobin \< 7 g/dL (will be measured before enrollment)
- Inability to tolerate oral treatment reflected by persistent vomiting of the study drugs.
- Known allergy to either the study drugs, or to any sulfa-containing medications.
- Age \<15 years.
- Age \>49 years.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00126971
Start Date
July 1 2005
Last Update
April 20 2025
Active Locations (1)
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1
Faladje Missionary Dispensary
Faladié, Mali