Evidence map›Paper›PMID 35109841›Full record

Trial reportMalaria journal2022

Efficacy of 3-day low dose quinine plus clindamycin versus artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children (CLINDAQUINE): an open-label randomized trial.

Charles O Obonyo, Elizabeth A Juma, Vincent O Were, Bernhards R Ogutu

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Malaria journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.2field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
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

4 authors at 1 institution in 1 country.

Charles O ObonyoCentre for Global Health Research, Kenya Medical Research Institute, P.O. Box 1578, Kisumu, Kenya. cobonyo65@yahoo.com.ORCID http://orcid.org/0000-0003-0741-8533
Elizabeth A JumaCentre for Clinical Research, Kenya Medical Research Institute, P.O. Box 20778, Nairobi, Kenya.
Vincent O WereCentre for Global Health Research, Kenya Medical Research Institute, P.O. Box 1578, Kisumu, Kenya.
Bernhards R OgutuCentre for Clinical Research, Kenya Medical Research Institute, P.O. Box 20778, Nairobi, Kenya.
Kenya Medical Research Institute · KE

Funding

European and Developing Countries Clinical Trials Partnership TA.2011.40200.059
6 · The paper itself

Abstract

backgroundThe World Health Organization recommends quinine plus clindamycin as first-line treatment of malaria in the first trimester of pregnancy and as a second-line treatment for uncomplicated falciparum malaria when artemisinin-based drug combinations are not available. The efficacy of quinine plus clindamycin was compared with that of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in children below 5 years of age.

methodsAn open-label, phase 3, randomized trial was conducted in western Kenya. Children aged 6-59 months with uncomplicated falciparum malaria were randomly assigned (1:1) via a computer-generated randomization list to receive 3 days of twice a day treatment with either oral quinine (20 mg/kg/day) plus clindamycin (20 mg/kg/day) or artemether-lumefantrine (artemether 20 mg, lumefantrine 120 mg) as one (for those weighing 5-14 kg) or two (for those weighing 15-24 kg) tablets per dose. The primary outcome was a PCR-corrected rate of adequate clinical and parasitological response (ACPR) on day 28 in the per-protocol population.

resultsOf the 384 children enrolled, 182/192 (94.8%) receiving quinine plus clindamycin and 171/192 (89.1%) receiving artemether-lumefantrine completed the study. The PCR-corrected ACPR rate was 44.0% (80 children) in the quinine plus clindamycin group and 97.1% (166 children) in the artemether-lumefantrine group (treatment difference - 53.1%, 95% CI - 43.5% to - 62.7%). At 72 h after starting treatment, 50.3% (94 children) in the quinine plus clindamycin group were still parasitaemic compared with 0.5% (1 child) in the artemether-lumefantrine group. Three cases of severe malaria were recorded as serious adverse events in the quinine plus clindamycin group.

conclusionsThe study found no evidence to support the use of a 3-day low dose course of quinine plus clindamycin in the treatment of uncomplicated falciparum malaria in children under 5 years of age in Kenya, where artemether-lumefantrine is still effective.

trial registrationThis trial is registered with the Pan-African Clinical Trials Registry, PACTR20129000419241.

Indexed as

Artemether, Lumefantrine Drug CombinationChild, PreschoolClindamycinDrug Therapy, CombinationFemaleHumansInfantKenyaMalaria, FalciparumMaleQuinineArtemether, Lumefantrine Drug CombinationClindamycinQuinineArtemether-lumefantrineChildrenClindamycinKenyaMalariaQuinine

Identifiers

PMID35109841
PMCPMC8809037
OpenAlexW4210519236

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.