NCT02575755

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Papua New Guinea Institute of Medical Research · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pregnancy
• Infections, Plasmodia
• Drug Kinetics
• Clinical Efficacy

Interventions

Type	Name	Description
DRUG	Azithromycin plus piperaquine phosphate
DRUG	Sulfadoxine-pyrimethamine

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-07-01
• Completion: 2016-10-01
• First posted: 2015-10-15
• Last updated: 2015-10-15

Locations

1 site across 1 country: Papua New Guinea