Pregnancy Clinical Trial
Official title:
A Safety, Tolerability, Pharmacokinetic and Efficacy Study of Azithromycin Plus Piperaquine as Presumptive Treatment in Pregnant Papua New Guinean Women
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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