Evidence map›Paper›PMID 25652127›Full record

Trial reportMalaria journal2015

Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated malaria in the setting of three different chemopreventive regimens.

James Kapisi, Victor Bigira, Tamara Clark, Stephen Kinara, Florence Mwangwa, Jane Achan, Moses Kamya, Seyi Soremekun, Grant Dorsey

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Malaria journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00948896 (A Randomized Controlled Trial of Monthly Dihydroartemisinin-piperaquine Versus Monthly Sulfadoxine-pyrimethamine Versus Daily Trimethoprim-sulfamethoxazole Versus No Therapy for the Prevention of Malaria), which is not on this map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 23% 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.

NCT00948896 phase3completednot on this map

A Randomized Controlled Trial of Monthly Dihydroartemisinin-piperaquine Versus Monthly Sulfadoxine-pyrimethamine Versus Daily Trimethoprim-sulfamethoxazole Versus No Therapy for the Prevention of Malaria

TypeinterventionalSponsorUniversity of California, San FranciscoRan2010 to 2014Enrolled600ConditionsMalariaArmstrimethoprim-sulfamethoxazole (TS, TMP/SMX), sulfadoxine-pyrimethamine (SP), dihydroartemisinin-piperaquine (DP)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 6 citations in OpenAlex.

  1. Intermittent preventive treatment for malaria in infants.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Intermittent preventive treatment for malaria in infants.The Cochrane database of systematic reviews · 2019
    Pooled it
  3. Article
  4. Article
  5. Article
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

9 authors at 5 institutions in 3 countries.

James KapisiInfectious Diseases Research Collaboration, Mulago Hospital Complex, PO Box 7475, Kampala, Uganda. kapisij@gmail.com.
Victor BigiraInfectious Diseases Research Collaboration, Mulago Hospital Complex, PO Box 7475, Kampala, Uganda. vbigira@gmail.com.
Tamara ClarkDepartment of Medicine, San Francisco General Hospital, University of California, San Francisco, CA, USA. tclark@medsfgh.ucsf.edu.
Stephen KinaraInfectious Diseases Research Collaboration, Mulago Hospital Complex, PO Box 7475, Kampala, Uganda. stvobonyo@yahoo.com.
Florence MwangwaInfectious Diseases Research Collaboration, Mulago Hospital Complex, PO Box 7475, Kampala, Uganda. frita26@gmail.com.
Jane AchanDepartment of Pediatrics, Makerere University College of Health Sciences, Kampala, Uganda. achan.jane@gmail.com.
Moses KamyaDepartment of Medicine, Makerere University College of Health Sciences, Kampala, Uganda. mkamya@infocom.co.ug.
Seyi SoremekunFaculty of Epidemiology and Public Health, London School of Hygiene and Tropical Medicine, London, UK. seyi.soremekun@lshtm.ac.uk.
Grant DorseyDepartment of Medicine, San Francisco General Hospital, University of California, San Francisco, CA, USA. gdorsey@medsfgh.ucsf.edu.
Mulago Hospital · UGMakerere University · UGUniversity of California, San Francisco · USInfectious Diseases Research Collaboration · UGLondon School of Hygiene & Tropical Medicine · GB

Funding

The immunologic consequences of prenatal exposure to malariaP01HD059454 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI HAVLIR, DIANE V · 2008 to 2017
$22.6M
FIC NIH HHS D43-TW00807701A1NICHD NIH HHS HD059454NICHD NIH HHS P01 HD059454
6 · The paper itself

Abstract

backgroundThe burden of malaria remains high for children in parts of Africa despite the use of insecticide-treated bed nets (ITNs). Chemoprevention has the potential of reducing the malaria burden; however, limited data exist on the efficacy and safety of anti-malarial therapy in the setting of chemoprevention.

methods600 children 4-5 months of age were enrolled in Tororo, Uganda, an area of high transmission intensity. Participants were given ITNs, and caregivers instructed to bring their child to a study clinic whenever they were ill. Starting at six months of age, 579 were randomized to no chemoprevention, monthly sulphadoxine-pyrimethamine (SP), daily trimethoprim-sulphamethoxazole (TS), or monthly dihydroartemisinin-piperaquine (DP). Study drugs were administered unsupervised at home until 24 months of age. Episodes of uncomplicated malaria were treated with artemether-lumefantrine (AL) with active follow-up for 28 days. The cumulative risk of recurrent malaria within 84 days and the risk of adverse events within 28 days were compared across study arms using a Cox proportional hazards model and generalized estimating equations, respectively.

resultsA total of 1007, 919, 736, and 451 episodes of malaria were treated in the no chemoprevention, SP, TS, and DP arms, respectively. Only 19 (0.6%) treatments were for severe malaria. Early response to therapy with AL was excellent with 96.5% fever clearance and 99.4% parasite clearance by day 3. However, over 50% of AL treatments were followed by recurrent parasitaemia within 28 days. Compared to the no chemoprevention arm, the cumulative risk of recurrent malaria within 84 days following treatment of uncomplicated malaria with AL was significantly lower in the DP arm (HR = 0.77, 95% CI 0.63-0.95, p = 0.01) but not the SP or TS arms. Compared to the no chemoprevention arm, none of the chemopreventive regimens were associated with an increased risk of adverse events following treatment of malaria with AL.

conclusionsThe risk of severe malaria was very low in this cohort of young children living in a high transmission setting. In the setting of chemoprevention, treatment of uncomplicated malaria with AL was safe and efficacious, with moderate protection against recurrent malaria among children assigned monthly DP.

trial registrationClinicalTrials.gov NCT00948896 .

Indexed as

AntimalarialsArtemether, Lumefantrine Drug CombinationArtemisininsChemopreventionChild, PreschoolDrug CombinationsDrug-Related Side Effects and Adverse ReactionsEthanolaminesFemaleFluorenesHumansInfantMalariaMaleRecurrenceTreatment OutcomeAntimalarialsArtemether, Lumefantrine Drug CombinationArtemisininsDrug CombinationsEthanolaminesFluorenes

Identifiers

PMID25652127
PMCPMC4333162
OpenAlexW2131067205

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.