Status:
COMPLETED
Evaluation of Alternative Antimalarial Drugs for Malaria in Pregnancy
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Barcelona Centre for International Health Research
Institute of Tropical Medicine, University of Tuebingen
Conditions:
Pregnancy
Malaria
Eligibility:
FEMALE
Phase:
NA
Brief Summary
The study aims at comparing the safety, tolerability and efficacy of Mefloquine (MQ) to Sulfadoxine-Pyrimethamine (SP) as Interment Preventive Treatment in pregnancy (IPTp) for the prevention of malar...
Detailed Description
The current recommendation by the World Health Organization (WHO) to prevent malaria infection in pregnancy in areas of stable malaria transmission relies on: * Prompt and effective case management o...
Eligibility Criteria
Inclusion
- Trial 1:
- Permanent resident in the area
- Gestational age at the first antenatal visit ≤ 28 weeks
- Signed informed consent
- Agreement to deliver in the study site's maternity(ies) wards
- Trial 2:
- Permanent resident in the area.
- Gestational age at the first antenatal visit ≤ 28 weeks
- HIV seropositive (after voluntary counseling and testing)
- Indication to receive CTX prophylaxis (according to the national guidelines)
- Signed informed consent
- Agreement to deliver in the study site's maternity(ies) wards.
Exclusion
- Trial 1:
- Residence outside the study area or planning to move out in the following 18 months from enrollment
- Gestational age at the first antenatal visit \> 28 weeks of pregnancy
- Known history of allergy to sulfa drugs or mefloquine
- Known history of severe renal, hepatic, psychiatric or neurological disease
- MQ or halofantrine treatment in the preceding 4 weeks
- HIV infection
- Participating in other studies
- Trial 2:
- Residence outside the study area or planning to move out in the following 10 months from enrollment
- Gestational age at the first antenatal visit \> 28 weeks of pregnancy
- Known history of allergy to CTX or MQ
- Known history of severe renal, hepatic, psychiatric or neurological disease
- MQ or halofantrine treatment in the preceding 4 weeks
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
5820 Patients enrolled
Trial Details
Trial ID
NCT00811421
Start Date
September 1 2009
End Date
December 1 2013
Last Update
March 20 2014
Active Locations (5)
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1
Faculté des Sciences de la Santé (FSS), Université d'Abomey Calavi
Allada, Benin
2
Medical Rsearch Unit (MRU), Albert Schweitzer Hospital
Lambaréné, Gabon
3
Kenya Medical Research Institute (KEMRI)/ CDC
Kisumu, Kenya
4
Centro de Investigaçao em Saúde da Manhiça (CISM)
Manhiça, Maputo Province, Mozambique