Malaria in Pregnancy Clinical Trial
— PREGACTOfficial title:
Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria
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 excluded from clinical trials; thus, the investigators lack sufficient information on the safety and efficacy of most antimalarials in pregnancy. The recommendation of the World Health Organization to use artemisinin combination therapy (ACT) in the 2nd and 3rd trimester is already implemented in several African countries, however documentation of their efficacy and safety in pregnancy is still limited. Thus, the investigators propose to evaluate the efficacy and safety of 4 ACT(artemether-lumefantrine, amodiaquine-artesunate, mefloquine-artesunate and dihydroartemisinin-piperaquine), when used to treat pregnant women with P. falciparum malaria; the results will help to recommend the optimal therapy for this high-risk group in Africa.
Status | Completed |
Enrollment | 3428 |
Est. completion date | April 2015 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 15 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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.) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Burkina Faso | ISSR/Centre Muraz | Nanoro | |
Burkina Faso | ISSR/Centre Muraz | Nazoanga | |
Ghana | Effiduase Government Hospital | Effiduase | |
Ghana | Kwame Nkrumah University of Science & Technology, Kumasi | Ejisu Sekyere East | Ashanti Region |
Ghana | Kwame Nrumah University of Science and Technology, Kumasi | Juaben Government Hospital | Ashanti Region |
Malawi | College of Medicine, University of Malawi | Chikwawa District Hospital | Blantyre |
Zambia | St Paul Hospital | Nchelenge | Nchelenge District |
Lead Sponsor | Collaborator |
---|---|
Institute of Tropical Medicine, Belgium | Centre Muraz, Institute of Tropical Medicine(KIT), Amsterdam, Kwame Nkrumah University of Science and Technology, Liverpool School of Tropical Medicine, National Institute for Medical Research, Tanzania, Tropical Diseases Research Centre, Zambia, University of Malawi College of Medicine |
Burkina Faso, Ghana, Malawi, Zambia,
PREGACT Study Group. Four Artemisinin-Based Treatments in African Pregnant Women with Malaria. N Engl J Med. 2016 Mar 10;374(10):913-927. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment Failure (PCR adjusted) | Day 63 | No | |
Primary | Safety profiles including significant changes in relevant laboratory values | Until delivery | Yes | |
Secondary | Time to failure | Case by case | No | |
Secondary | PCR unadjusted treatment failure | Day 63 | No | |
Secondary | Gametocyte carriage (gametocyte-weeks) | Case by case | No | |
Secondary | Asexual parasite clearance time | Days to 2 consecutive negative blood slides. | No | |
Secondary | Gametocytaemia (prevalence and density) | Day 7, 14, 21, 28 and 63 after treatment | No | |
Secondary | Haemoglobin changes | Days 14, 28, 42 and 63 | Yes | |
Secondary | The presence of acute, chronic or past infection of the placenta (prevalence) | Delivery | Yes | |
Secondary | Mean birth weight and prevalence of low birth weight newborns | Delivery | Yes | |
Secondary | In vitro vitro and search of molecular markers related to drug resistance | At the time of recurrent infection | Yes | |
Secondary | Determination of the PK profile of MQ, AQ and PQ (on 120 women/treatment) | Case by case | No |
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