Format

Send to

Choose Destination
Trials. 2018 Nov 6;19(1):610. doi: 10.1186/s13063-018-2972-1.

Malaria chemoprevention with monthly dihydroartemisinin-piperaquine for the post-discharge management of severe anaemia in children aged less than 5 years in Uganda and Kenya: study protocol for a multi-centre, two-arm, randomised, placebo-controlled, superiority trial.

Author information

1
Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR), PO Box 1578, Kisumu, 40100, Kenya. titus.kwambai@lstmed.ac.uk.
2
Kisumu County Department of Health, Kenya Ministry of Health, Kisumu, Kenya. titus.kwambai@lstmed.ac.uk.
3
Department of Clinical Sciences, Liverpool School of Tropical Medicine (LSTM), Liverpool, UK. titus.kwambai@lstmed.ac.uk.
4
Makerere University College of Health Sciences, Kampala, Uganda.
5
Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR), PO Box 1578, Kisumu, 40100, Kenya.
6
Malaria Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA.
7
Department of Global Child Health, Emma Children's Hospital Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
8
Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, Indianapolis, IN, USA.
9
Centre for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
10
Department of Clinical Sciences, Liverpool School of Tropical Medicine (LSTM), Liverpool, UK.
11
College of Medicine, University of Malawi, Blantyre, Malawi.

Abstract

BACKGROUND:

Children hospitalised with severe anaemia in malaria endemic areas in Africa are at high risk of readmission or death within 6 months post-discharge. Currently, no strategy specifically addresses this period. In Malawi, 3 months of post-discharge malaria chemoprevention (PMC) with monthly treatment courses of artemether-lumefantrine given at discharge and at 1 and 2 months prevented 30% of all-cause readmissions by 6 months post-discharge. Another efficacy trial is needed before a policy of malaria chemoprevention can be considered for the post-discharge management of severe anaemia in children under 5 years of age living in malaria endemic areas.

OBJECTIVE:

We aim to determine if 3 months of PMC with monthly 3-day treatment courses of dihydroartemisinin-piperaquine is safe and superior to a single 3-day treatment course with artemether-lumefantrine provided as part of standard in-hospital care in reducing all-cause readmissions and deaths (composite primary endpoint) by 6 months in the post-discharge management of children less than 5 years of age admitted with severe anaemia of any or undetermined cause.

METHODS/DESIGN:

This is a multi-centre, two-arm, placebo-controlled, individually randomised trial in children under 5 years of age recently discharged following management for severe anaemia. Children in both arms will receive standard in-hospital care for severe anaemia and a 3-day course of artemether-lumefantrine at discharge. At 2 weeks after discharge, surviving children will be randomised to receive either 3-day courses of dihydroartemisinin-piperaquine at 2, 6 and 10 weeks or an identical placebo and followed for 26 weeks through passive case detection. The trial will be conducted in hospitals in malaria endemic areas in Kenya and Uganda. The study is designed to detect a 25% reduction in the incidence of all-cause readmissions or death (composite primary outcome) from 1152 to 864 per 1000 child years (power 80%, α = 0.05) and requires 520 children per arm (1040 total children).

RESULTS:

Participant recruitment started in May 2016 and is ongoing.

TRIAL REGISTRATION:

ClinicalTrials.gov, NCT02671175 . Registered on 28 January 2016.

KEYWORDS:

Chemoprevention; Cost-effectiveness; Dihydroartemisinin-piperaquine; Malaria; Mortality; Post-discharge; Protocol; Readmission; Severe anaemia

Supplemental Content

Full text links

Icon for BioMed Central Icon for PubMed Central
Loading ...
Support Center