Evaluation of azithromycin plus piperaquine as intermittent presumptive treatment in pregnant Papua New Guinean women
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:
- A safety, tolerability and pharmacokinetic study of AZI-PQ in pregnancy.
- A safety, tolerability and preliminary efficacy study of AZI-PQ in pregnancy.
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.
ClinicalTrials.gov Identifier: NCT02575755
Study Phase: Phase 4
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention