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

Autor: Christine Manyando, Modest Mulenga, Jay Sikalima, Gershom Chongwe, Clifford Tende, Matthew M. Ippolito, D. Champo, David Mwakazanga, Jean-Bertin Bukasa Kabuya, Anna Marie P. Young
Rok vydání: 2021
Předmět:
Medicine (General)
Pediatrics
medicine.medical_specialty
Malaria in pregnancy
Placenta
Zambia
Medicine (miscellaneous)
HIV Infections
Intermittent presumptive therapy
Congenital malaria
law.invention
Study Protocol
Antimalarials
R5-920
Dihydroartemisinin/piperaquine
Randomized controlled trial
Pregnancy
law
Sulfadoxine
parasitic diseases
medicine
Humans
Pharmacology (medical)
Randomized Controlled Trials as Topic
Retrospective Studies
Rapid diagnostic test
Diagnostic Tests
Routine
business.industry
Infant
Prenatal Care
medicine.disease
Artemisinins
Sulfadoxine/pyrimethamine
Clinical trial
Drug Combinations
Regimen
Pyrimethamine
Clinical Trials
Phase III as Topic
Pregnancy Complications
Parasitic
Sulfadoxine-pyrimethamine
Quinolines
Female
medicine.symptom
business
Malaria
Dihydroartemisinin-piperaquine
medicine.drug
Zdroj: Trials
Trials, Vol 22, Iss 1, Pp 1-12 (2021)
Popis: Background Intermittent 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. Methods This 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. Discussion A 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 registration Pan African Clinical Trials Registry 201905721140808. Registered retrospectively on 11 May 2019
Databáze: OpenAIRE
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