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: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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

Criteria

Inclusion Criteria:

• >14 weeks and <30 weeks gestation

• No signs of severe malaria by World Health Organisation criteria

• No significant concomitant disease (such as TB)

• No prior history of an adverse reaction to AZI or PQP

• No prior treatment with these drugs in the past 4 weeks

• Can attend all follow-up visits

• Provide informed consent

Exclusion Criteria:

• Have signs of severe malaria by WHO criteria

• Significant concomitant disease such as TB as assessed by the attending clinician

• A history/family history of sudden death or of congenital prolongation of the QTc interval

• Any clinical condition known to prolong the QTc interval

• A history of complicated pregnancies/deliveries

• A prior history of an adverse reaction to AZI or PQP

• Have taken these drugs in the past 4 weeks

• Cannot attend any of the follow-up visits

• Do not provide informed consent