Status:
COMPLETED
Pharmacokinetic of Mefloquine-Artesunate in Plasmodium Falciparum Malaria Infection in Pregnancy
Lead Sponsor:
Institute of Tropical Medicine, Belgium
Collaborating Sponsors:
Centre Muraz
Liverpool School of Tropical Medicine
Conditions:
Plasmodium Falciparum Malaria
Eligibility:
FEMALE
18-49 years
Phase:
PHASE2
PHASE3
Brief Summary
Malaria in pregnancy is a major public health problem in Sub-Saharan Africa. Over the past decades, P. falciparum has shown increasing resistance to chloroquine and Sulphadoxine-Pyrimethamine, which h...
Detailed Description
Malaria during pregnancy constitutes a major public health problem in Sub-Saharan Africa, where it increases the risk of low birth weight (\<2500g), infant mortality, infant morbidity during the first...
Eligibility Criteria
Inclusion
- Plasmodium falciparum monoinfection (any density)
- At least 18 years old;
- Haemoglobin at leats 7 g/dL;
- Residence within the health facility catchment's area;
- Willing to adhere to the study requirements
- Willing to deliver in health facility
- Ability to provide written informed consent
- EITHER pregnant women in the 2nd or 3rd trimester (cases)or non-pregnant women between the ages of 18 and 49 years (controls).
Exclusion
- Pregnancy 1st trimester
- History of known pregnancy complications or bad obstetric history such as repeated stillbirths or eclampsia;
- Known 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 presenting illness 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 treatment with antimicrobials with antimalarial activity (erythromycin or other macrolides, co-trimoxazole or other sulfonamides, any tetracycline including doxycycline, quinolones and clindamycin) or exposure to antimalarial drugs within the week prior enrollment.
- History of allergy or hypersensivity to interventional drugs
- Patients taking drugs with possible interaction with study drugs (i.e. digoxin or warfarin)
- History or family history of epilepsy or psychiatric disorder
- Presence of signs and symptoms of severe malaria
- Inability to tolerate oral medication (repeated vomiting, impairment of consciousness). Vomiting of any of the treatment doses will lead to exclusion from the pharmacokinetic sampling.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00701961
Start Date
October 1 2008
End Date
July 1 2009
Last Update
September 14 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Muraz
Nanoro, Burkina Faso