Evaluation of Alternative Antimalarial Drugs for Malaria in Pregnancy

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

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 malaria effects on the mother and her infant.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital Clinic of Barcelona
• Collaborators: Albert Schweitzer Hospital; Barcelona Centre for International Health Research; Centers for Disease Control and Prevention; Centro de Investigacao em Saude de Manhica; Ifakara Health Institute; Institut de Recherche pour le Developpement; Institute of Tropical Medicine, University of Tuebingen; Kenya Medical Research Institute; Malaria in Pregnancy Consortium; Université d'Abomey-Calavi; Vienna School of Clinical Research (VSCR), Austria.
• Treatments: Fanasil, pyrimethamine drug combination; Mefloquine; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

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 Criteria:

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