Evidence map›Paper›PMID 30400934›Full record

ArticleTrials2018

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.

Titus K Kwambai, Aggrey Dhabangi, Richard Idro, Robert Opoka, Simon Kariuki, Aaron M Samuels, Meghna Desai, Michael Boele van Hensbroek, Chandy C John, Bjarne Robberstad and 3 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.5field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02671175 phase3completednot on this map

Malaria Chemoprevention With Monthly Treatment With Dihydroartemisinin-piperaquine for the Post-discharge Management of Severe Anaemia in Children Aged Less Than 5 Years in Uganda and Kenya: A Two-arm Randomised Placebo Controlled Trial

TypeinterventionalSponsorLiverpool School of Tropical MedicineRan2016 to 2018Enrolled1,049ConditionsMalaria, Severe AnemiaArmsdihydroartemisinin-piperaquine, dihydroartemisinin-piperaquine placebo
NCT04844099 phase3completednot on this mapstarted 2021, after this paper: background citation

Dihydroartemisinin-Piperaquine or Sulphadoxine-Pyrimethamine for the Chemoprevention of Malaria in Children With Sickle Cell Anaemia in Eastern and Southern Africa: a Double Blind Randomised Trial (CHEMCHA)

TypeinterventionalSponsorLiverpool School of Tropical MedicineRan2021 to 2023Enrolled723ConditionsSickle Cell Anemia in Children, MalariaArmsDihydroartemisinin Piperaquine
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 21 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 7 countries.

Titus K KwambaiKenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR), PO Box 1578, Kisumu, 40100, Kenya. titus.kwambai@lstmed.ac.uk.ORCID http://orcid.org/0000-0003-1930-0911
Aggrey DhabangiMakerere University College of Health Sciences, Kampala, Uganda.
Richard IdroMakerere University College of Health Sciences, Kampala, Uganda.
Robert OpokaMakerere University College of Health Sciences, Kampala, Uganda.
Simon KariukiKenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR), PO Box 1578, Kisumu, 40100, Kenya.
Aaron M SamuelsMalaria Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA.
Meghna DesaiMalaria Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA.
Michael Boele van HensbroekDepartment of Global Child Health, Emma Children's Hospital Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
Chandy C JohnRyan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, Indianapolis, IN, USA.
Bjarne RobberstadCentre for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
Duolao WangDepartment of Clinical Sciences, Liverpool School of Tropical Medicine (LSTM), Liverpool, UK.
Kamija PhiriCollege of Medicine, University of Malawi, Blantyre, Malawi.
Feiko O Ter KuileKenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR), PO Box 1578, Kisumu, 40100, Kenya.
Liverpool School of Tropical Medicine · GBMakerere University · UGCenters for Disease Control and Prevention · USEmma Kinderziekenhuis · NLIndiana University School of MedicineKenya Medical Research Institute · KEUniversity of Bergen · NOUniversity of Malawi · MW

Funding

ACL HHS U01GH001646Malaria Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention 1U01GH001646Norges Forskningsråd 234487
6 · The paper itself

Abstract

backgroundChildren 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.

objectiveWe 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/

designThis 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).

resultsParticipant recruitment started in May 2016 and is ongoing.

trial registrationClinicalTrials.gov, NCT02671175 . Registered on 28 January 2016.

Indexed as

Randomized Controlled Trials as TopicAnemiaArtemisininsChemopreventionChild, PreschoolDouble-Blind MethodDrug CombinationsEquivalence Trials as TopicHumansInfantInfant, NewbornKenyaMalariaMulticenter Studies as TopicPiperazinesQuinolinesArtemisininsartenimolDrug CombinationspiperaquinePiperazinesQuinolinesChemopreventionCost-effectivenessDihydroartemisinin-piperaquineMalariaMortalityPost-dischargeProtocolReadmissionSevere anaemia

Identifiers

PMID30400934
PMCPMC6220494
OpenAlexW2900254938

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.