Evaluation of Alternative Antimalarial Drugs for Malaria in Pregnancy

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.

Conditions

• Pregnancy
• Malaria
• HIV Infections

Interventions

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

Sponsors & Collaborators

• Barcelona Centre for International Health Research

  collaborator OTHER

• Institute of Tropical Medicine, University of Tuebingen

  collaborator OTHER

• Institut de Recherche pour le Developpement

  collaborator OTHER_GOV

• Université d'Abomey-Calavi

  collaborator OTHER

• Albert Schweitzer Hospital

  collaborator OTHER

• Kenya Medical Research Institute

  collaborator OTHER

• Ifakara Health Institute

  collaborator OTHER

• Centro de Investigacao em Saude de Manhica

  collaborator OTHER

• Vienna School of Clinical Research (VSCR), Austria.

  collaborator UNKNOWN

• Centers for Disease Control and Prevention

  collaborator FED

• Malaria in Pregnancy Consortium

  collaborator OTHER

• Hospital Clinic of Barcelona

  lead OTHER

Principal Investigators

• Clara Menendez, MD, PhD · Barcelona Centre for International Health Research

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-09-30

Primary Completion

2012-12-31

Completion

2013-12-31

Countries

• Benin
• Gabon
• Kenya
• Mozambique
• Tanzania

Study Locations