Improving PRegnancy Outcomes With Intermittent preVEntive Treatment in Africa

Summary

This study evaluates the efficacy and safety of monthly intermittent preventive treatment using dihydroartemisinin piperaquine (DP) alone or in combination with azithromycin (AZ) compared to sulphadoxine-pyrimethamine (SP) for the prevention of malaria in pregnant women in the second and third trimester.

Conditions

• Pregnancy
• Malaria in Pregnancy
• Malaria

Interventions

DRUG

dihydroartemisinin-piperaquine

Women randomised to this intervention will receive 3 day treatment dose of dihydroartemisinin-piperaquine by body weight plus azithromycin placebo

DRUG

sulphadoxine-pyrimethamine

Women randomised to this intervention will receive stat dose of 3 tablets of 500 mg sulphadoxine and 25 mg of pyrimethamine each (total dose of 1,500mg sulphadoxine and 75mg pyrimethamine) on a single day of clinic visit

DRUG

dihydroartemisinin-piperaquine plus azithromycin

Women randomised to this intervention will receive 3 day treatment dose of dihydroartemisinin-piperaquine by body weight plus azithromycin (500mg)

Sponsors & Collaborators

• Kamuzu University of Health Sciences

  collaborator OTHER

• Kenya Medical Research Institute

  collaborator OTHER

• Malawi-Liverpool-Wellcome Trust Clinical Research Programme

  collaborator OTHER

• National Institute for Medical Research, Tanzania

  collaborator OTHER_GOV

• Kilimanjaro Christian Medical Centre, Tanzania

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• Centers for Disease Control and Prevention

  collaborator FED

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• University College, London

  collaborator OTHER

• Tampere University

  collaborator OTHER

• University of Bergen

  collaborator OTHER

• University of Massachusetts, Worcester

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• University of Melbourne

  collaborator OTHER

• Foundation for Innovative New Diagnostics, Switzerland

  collaborator OTHER

• Liverpool School of Tropical Medicine

  lead OTHER

Principal Investigators

• Simon K Kariuki, PhD · Kenya Medical Research Institute

• Frank Mosha, PhD · Kilimanjaro Christian Medical University College

• John Lusingu, PhD · National Institute for Medical Research

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-03-29

Primary Completion

2020-03-15

Completion

2020-03-15

Countries

• Kenya
• Malawi
• Tanzania

Study Locations