Last Updated

11 Oct 2019

Evaluation of azithromycin plus piperaquine as intermittent presumptive treatment in pregnant Papua New Guinean women

Objectives

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:

  1. A safety, tolerability and pharmacokinetic study of AZI-PQ in pregnancy. 
  2. A safety, tolerability and preliminary efficacy study of AZI-PQ in pregnancy.
Principal Investigator
Rationale and Abstract

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.

Study Design

ClinicalTrials.gov Identifier: NCT02575755
Study Phase: Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Date

2012 Oct - 2016 Oct

Total Project Funding

$345,684

Funding Details

Project Site