Safety and efficacy of intermittent presumptive treatment with sulfadoxine-pyrimethamine using rapid diagnostic test screening and treatment with dihydroartemisinin-piperaquine at the first antenatal care visit (IPTp-SP+): study protocol for a randomized controlled trial

Trials

Modest Mulenga¹  Jean-Bertin Bukasa Kabuya¹  Jay Sikalima¹  Clifford Tende¹  Davies Champo¹  David Mwakazanga¹  Christine Manyando¹  Gershom Chongwe¹  Anna Marie P. Young²  Matthew M. Ippolito³ 

[1] Department of Clinical Sciences, Tropical Diseases Research Centre, P.O. Box 71769, Copperbelt Province, Ndola, Zambia;Johns Hopkins University School of Medicine, Baltimore, MD, USA;Johns Hopkins University School of Medicine, Baltimore, MD, USA;Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA;

关键词: Malaria in pregnancy;    Intermittent presumptive therapy;    Zambia;    Sulfadoxine-pyrimethamine;    Dihydroartemisinin-piperaquine;   

DOI  :  10.1186/s13063-021-05745-0

来源: Springer

【 摘 要 】

BackgroundIntermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended by the World Health Organization for the prevention of malaria in pregnancy (MIP)-associated adverse outcomes in high burden areas. However, the efficacy of IPTp-SP has decreased in step with increasing parasite drug resistance. Suitable alternative strategies are needed.MethodsThis is a protocol for a phase IIIb open-label, two-armed randomized controlled superiority trial to assess the safety and efficacy of a hybrid approach to IPTp combining screening and treatment with dihydroartemisinin-piperaquine (DP) to the current IPTp-SP regimen at the first antenatal care clinic visit. Pregnant women without HIV infection and without signs or symptoms of malaria will be randomized to either standard IPTp-SP or hybrid IPTp-SP plus screening and treatment (IPTp-SP+). In the IPTp-SP+ arm, participants who screen positive by rapid diagnostic test for P. falciparum will be treated with DP at the first antenatal visit while those who screen negative will receive SP per current guidelines. All participants will be administered SP on days 35 and 63 and will be actively followed biweekly up to day 63 and then monthly until delivery. Infants will be followed until 1 year after delivery. The primary endpoint is incident PCR-confirmed MIP at day 42. Secondary endpoints include incident MIP at other time points, placental malaria, congenital malaria, hemoglobin trends, birth outcomes, and incidence of adverse events in infants up to the first birthday.DiscussionA hybrid approach to IPTp that combines screening and treatment with an artemisinin-based combination therapy at the first visit with standard IPTp-SP is hypothesized to confer added benefit over IPTp-SP alone in a high malaria transmission area with prevalent SP resistant parasites.Trial registrationPan African Clinical Trials Registry 201905721140808. Registered retrospectively on 11 May 2019

【 授权许可】

CC BY