NCT00811421

Evaluation of Alternative Antimalarial Drugs for Malaria in Pregnancy

Evaluation of the Safety and Efficacy of Mefloquine as Intermittent Preventive Treatment of Malaria in Pregnancy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,820 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

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 of malaria illness * The use of intermittent preventive treatment (IPTp) with at least 2 treatment doses of sulfadoxine-pyrimethamine (SP) and * The use of insecticide treated nets (ITNs) However, the spread of parasite resistance to SP, particularly in eastern Africa, and the significant overlap in some regions of malaria transmission and high prevalence of HIV infection, have raised concerns about the medium and long-term use of SP for IPTp. HIV infection increases susceptibility to malaria and may reduce the efficacy of interventions. The evaluation of alternative antimalarials for IPTp is thus urgently needed also involving HIV infected women. Of all the current available alternative antimalarial drugs, mefloquine (MQ) is the one that offers the most comparative advantages to SP. A randomized multicenter trial will be conducted in 4 sites in Africa (Benin, Gabon, Tanzania and Mozambique) in order to compare the safety and efficacy of SP versus MQ as IPTp in the context of ITNs. In addition, MQ tolerability will be also evaluated by comparing the administration of MQ as a single intake with its administration as split dose in two days. In total 4716 pregnant women will be enrolled at the antenatal clinic (ANC) and will be followed until the infant is one year old. Besides, in those countries where HIV prevalence in pregnant women is \> 10%, MQ-IPTp will be compared to Placebo-IPTp in HIV infected pregnant women receiving cotrimoxazole (CTX) prophylaxis. This trial will be double blinded and will be carried out in Kenya, Tanzania and Mozambique. It will involve 1070 pregnant women that will be followed until the infant is 2 months old.

Conditions

• Pregnancy
• Malaria
• HIV Infections

Interventions

Type	Name	Description
DRUG	Sulphadoxine-pyrimethamine	SP oral administration (500mg sulphadoxine and 25mg pyrimethamine) as IPTp at the 1st and 2nd Antenatal Clinic visit
DRUG	Mefloquine (full dose)	MQ oral administration (15 mg/Kg) on 1 day at the 1st and 2nd Antenatal Clinic visit as IPTp
DRUG	Mefloquine (split dose)	MQ oral administration (15 mg/kg) split dose over 2 days at the 1st and 2nd ANC visit as IPTp
DRUG	placebo	MQ-placebo oral administration at the 1st, 2nd and 3rd Antenatal Clinic visit as IPTp
DRUG	mefloquine	MQ oral administration (15 mg/Kg) at the 1st and 2nd Antenatal Clinic visit as IPTp

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-12-01
• Completion: 2013-12-01
• First posted: 2008-12-19
• Last updated: 2014-03-20

Locations

5 sites across 5 countries: Benin, Gabon, Kenya, Mozambique, Tanzania