CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5,820 enrolled
Drug / intervention
Sulphadoxine-pyrimethamine +4 moredrug
Likely dose
Sulphadoxine-pyrimethamine 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00811421
NCT00811421N/ACompleted
CompareCT.gov

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

Hospital Clinic of Barcelona·interventional·Posted Dec 19, 2008·Updated Mar 20, 2014

In Brief

A clinical study evaluating Sulphadoxine-pyrimethamine, Mefloquine (full dose), and 3 other interventions for Pregnancy and 2 related conditions. Completed, enrolled 5,820 participants across 5 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy, Malaria, HIV Infections
CountriesBenin, Gabon, Kenya, Mozambique, Tanzania
CollaboratorsBarcelona Centre for International Health Research, Institute of Tropical Medicine, University of Tuebingen, Institut de Recherche pour le Developpement, Université d'Abomey-Calavi, Albert Schweitzer Hospital, Kenya Medical Research Institute, Ifakara Health Institute, Centro de Investigacao em Saude de Manhica, Vienna School of Clinical Research (VSCR), Austria., Centers for Disease Control and Prevention, Malaria in Pregnancy Consortium

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 19, 2008
Enrollment StartSep 1, 2009
Primary CompletionDec 1, 2012
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.5 years ago

Interventions

Sulphadoxine-pyrimethaminedrug

SP oral administration (500mg sulphadoxine and 25mg pyrimethamine) as IPTp at the 1st and 2nd Antenatal Clinic visit

Mefloquine (full dose)drug

MQ oral administration (15 mg/Kg) on 1 day at the 1st and 2nd Antenatal Clinic visit as IPTp

Mefloquine (split dose)drug

MQ oral administration (15 mg/kg) split dose over 2 days at the 1st and 2nd ANC visit as IPTp

placebodrug

MQ-placebo oral administration at the 1st, 2nd and 3rd Antenatal Clinic visit as IPTp

mefloquinedrug

MQ oral administration (15 mg/Kg) at the 1st and 2nd Antenatal Clinic visit as IPTp