Overview

A Safety, Tolerability, Pharmacokinetic and Efficacy Study of Azithromycin Plus Piperaquine as Presumptive Treatment in Pregnant PNG Women

Status:
Unknown status

Trial end date:
2016-10-01

Target enrollment:

Participant gender:

Summary

Plasmodium falciparum parasitaemia in pregnancy is associated with maternal anaemia, low birth-weight and increased perinatal mortality. Whilst continuous prophylaxis is difficult to implement, intermittent presumptive treatment in pregnancy (IPTp) has proved to be practical and effective. In PNG, pregnant women currently receive IPTp using sulfadoxine-pyrimethamine, however, this therapy has the potential to be compromised by parasite resistance. The aim of the present trial is to assess the safety, tolerability, pharmacokinetics and efficacy of azithromycin (AZI) plus piperaquine (PQ) given as IPTp to pregnant Papua New Guinea women. The study will comprise of two sub-studies: (i) A safety, tolerability and pharmacokinetic study of AZI-PQ in pregnancy. (ii) A safety, tolerability and preliminary efficacy study of AZI-PQ in pregnancy.

Phase:

Phase 4

Details

Lead Sponsor:

Papua New Guinea Institute of Medical Research

Collaborators:

Malaria in Pregnancy Consortium
The University of Western Australia
University of Melbourne

Treatments:

Azithromycin
Fanasil, pyrimethamine drug combination
Piperaquine
Pyrimethamine
Sulfadoxine