NCT03208179

Improving PRegnancy Outcomes With Intermittent preVEntive Treatment in Africa

IPTp With Dihydroartemisinin-piperaquine and Azithromycin for Malaria, Sexually Transmitted and Reproductive Tract Infections in Pregnancy in High Sulphadoxine-pyrimethamine Resistance Areas in Kenya, Malawi and Tanzania

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,680 (actual)
• Sponsor: Liverpool School of Tropical Medicine · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the efficacy and safety of monthly intermittent preventive treatment using dihydroartemisinin piperaquine (DP) alone or in combination with azithromycin (AZ) compared to sulphadoxine-pyrimethamine (SP) for the prevention of malaria in pregnant women in the second and third trimester.

Detailed description

Intermittent preventive treatment with sulphadoxine-pyrimethamine (IPTp-SP) is one of the pillars of malaria prevention in pregnancy in sub-Saharan Africa, in addition to prompt case management and use of long lasting insecticide treated bednets. However, mounting resistance to SP by Plasmodium falciparum increasing renders IPTP-SP ineffective. Two exploratory trials in Uganda and Kenya demonstrated that IPTp with DP was superior to IPTp-SP for the prevention of malaria infection in pregnancy. However, neither study was adequately powered to look at adverse birth outcomes. This study is a confirmatory efficacy trial in Malawi, Tanzania and Kenya to determine the efficacy and safety of IPTp with DP alone or in combination with AZ. This will be a 3-arm trial, superiority, partial blinded, placebo controlled, randomized trial comparing IPTp with SP, versus IPTp with DP alone, and IPTp with DP+AZ with the following hypotheses: * IPTp with DP is superior to IPTp with SP in preventing adverse pregnancy outcomes. * The combination of DP with AZ further reduces adverse pregnancy outcomes compared to IPTp with DP alone.

Conditions

• Pregnancy
• Malaria in Pregnancy
• Malaria

Interventions

Type	Name	Description
DRUG	dihydroartemisinin-piperaquine	Women randomised to this intervention will receive 3 day treatment dose of dihydroartemisinin-piperaquine by body weight plus azithromycin placebo
DRUG	sulphadoxine-pyrimethamine	Women randomised to this intervention will receive stat dose of 3 tablets of 500 mg sulphadoxine and 25 mg of pyrimethamine each (total dose of 1,500mg sulphadoxine and 75mg pyrimethamine) on a single day of clinic visit
DRUG	dihydroartemisinin-piperaquine plus azithromycin	Women randomised to this intervention will receive 3 day treatment dose of dihydroartemisinin-piperaquine by body weight plus azithromycin (500mg)

Timeline

• Start date: 2018-03-29
• Primary completion: 2020-03-15
• Completion: 2020-03-15
• First posted: 2017-07-05
• Last updated: 2022-06-27

Locations

7 sites across 3 countries: Kenya, Malawi, Tanzania