Status:
COMPLETED
Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria
Lead Sponsor:
Institute of Tropical Medicine, Belgium
Collaborating Sponsors:
National Institute for Medical Research, Tanzania
Kwame Nkrumah University of Science and Technology
Conditions:
Malaria in Pregnancy
Eligibility:
FEMALE
15+ years
Phase:
PHASE3
Brief Summary
Malaria is the most important human parasitic disease and is responsible of high morbidity and mortality in resource-poor countries. Pregnant women, who are a high-risk group, are almost always exclud...
Detailed Description
Malaria is the most important human parasitic disease. Although pregnant women are a high-risk group, they are almost systematically excluded from clinical trials, for fear of teratogenicity and embry...
Eligibility Criteria
Inclusion
- Gestation of at least 16 weeks and \<37 weeks;
- P. falciparum monoinfection of any density, with or without symptoms
- Hb equal or higher than 7 g/dL;
- At least 15 years old;
- Residence within the health facility catchment's area;
- Willing to deliver at the health facility;
- Willing to adhere to study requirements (including in Zambia and Malawi, HIV VCT)
- Ability to provide written informed consent; if the woman is minor of age/not emancipated, the consent must be given by a parent or legal guardian according to national law (however, in this case, the investigator is responsible to check that the woman herself is also freely willing to take part in the study, and the woman will be asked to sign for "assent").
Exclusion
- History of allergic reactions to the study drugs;
- History of known pregnancy complications or bad obstetric history such as repeated stillbirths or eclampsia;
- History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis;
- Current cotrimoxazole prophylaxis or ARV treatment;
- Any significant illness at the time of screening that requires hospitalization, including severe malaria;
- Intent to move out of the study catchment area before delivery or deliver at relative's home out of the catchment area.
- Prior enrollment in the study or concurrent enrollment in another study.
- Unable to take oral medication
- Clear evidence of recent (1 week) treatment with antimalarials or antimicrobials with antimalarial activity (clindamycin; azythromycin; etc.)
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
3428 Patients enrolled
Trial Details
Trial ID
NCT00852423
Start Date
June 1 2010
End Date
April 1 2015
Last Update
March 14 2016
Active Locations (7)
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1
ISSR/Centre Muraz
Nanoro, Burkina Faso
2
ISSR/Centre Muraz
Nazoanga, Burkina Faso
3
Kwame Nkrumah University of Science & Technology, Kumasi
Ejisu Sekyere East, Ashanti Region, Ghana
4
Kwame Nrumah University of Science and Technology, Kumasi
Juaben Government Hospital, Ashanti Region, Ghana