Evidence map›Paper›PMID 31795967›Full record

Trial reportBMC infectious diseases2019

Piperaquine concentration and malaria treatment outcomes in Ugandan children treated for severe malaria with intravenous Artesunate or quinine plus Dihydroartemisinin-Piperaquine.

Pauline Byakika-Kibwika, Ronald Ssenyonga, Mohammed Lamorde, Daniel Blessborn, Joel Tarning

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC infectious diseases, 2019. 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
1.1field-weighted citation impact, top 20% 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, 9 citations in OpenAlex.

  1. Review
  2. Review
  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

5 authors at 3 institutions in 3 countries.

Pauline Byakika-KibwikaDepartment of Medicine, Makerere University College of Health Sciences, Kampala, Uganda. pbyakika@gmail.com.ORCID http://orcid.org/0000-0003-0757-1968
Ronald SsenyongaClinical Trials Unit, Makerere University College of Health Sciences, Kampala, Uganda.
Mohammed LamordeInfectious Diseases Institute, Kampala, Uganda.
Daniel BlessbornMahidol-Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok, Thailand.
Joel TarningMahidol-Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok, Thailand.
Infectious Diseases Institute · UGMahidol University · THMakerere University · UG

Funding

European and Developing Countries Clinical Trials Partnership TA 2009.40200.020International Society for Infectious Diseases 077166/Z/05/Z
6 · The paper itself

Abstract

backgroundTreatment for severe malaria must be prompt with effective parenteral antimalarial drugs for at least 24 h to achieve fast parasite clearance, and when the patient can tolerate oral therapy, treatment should be completed with effective artemisinin based combination therapy (ACT) for complete parasite clearance and to prevent recrudescence. We evaluated piperaquine concentration and malaria treatment outcomes among Ugandan children treated for severe malaria with intravenous artesunate (AS) or quinine (QN) plus dihydroartemisinin-piperaquine (DP), in Tororo District Hospital in Eastern Uganda.

methodsCapillary blood piperaquine concentration data were obtained from a randomized clinical trial whose objective was to evaluate parasite clearance, 42-day parasitological treatment outcomes and safety, following treatment of severe malaria with intravenous AS or QN, plus artemether-lumefantrine or DP among children in Tororo District Hospital, in Eastern Uganda.

resultsPiperaquine concentration data from 150 participants who received DP were analyzed. Participants with unadjusted treatment failure had lower median day 7 capillary piperaquine concentration than those with treatment success (34.7 (IQR) (17.9-49.1) vs 66.7 (IQR) (41.8-81.9), p < 0.001), and lower than the recommended day 7 cut off level of 57 ng/mL. There was no difference in median capillary piperaquine concentrations among participants with re-infection and recrudescence (35.3 (IQR) (17.9-55.2) vs 34.8 (IQR) (18.1-45.1), p = 0.847). The risk of treatment failure was two times higher among children with low (< 57 ng/mL) day 7 capillary piperaquine concentration (relative risk: 2.1 CI 1.4-3.1), p < 0.001) compared to children with high day 7 capillary piperaquine concentrations (> 57 ng/mL).

conclusionConsidering the low day 7 concentrations of piperaquine reported in the patients studied here, we suggest to adopt the recently recommended higher dose of DP in young children or a prolonged 5-day dosing in children living in malaria endemic areas who have suffered an initial episode of severe malaria in order to achieve adequate drug exposures for effective post-treatment prophylactic effects.

trial registrationThe study was registered with the Pan African Clinical Trial Registry (PACTR201110000321348). Registered 7th October 2011.

Indexed as

Administration, IntravenousAntimalarialsArtemisininsArtesunateChild, PreschoolFemaleFollow-Up StudiesHumansInfantMalaria, FalciparumMaleOsmolar ConcentrationPiperazinesPlasmodium falciparumQuinineQuinolinesAntimalarialsArtemisininsartenimolArtesunatepiperaquinePiperazinesQuinineQuinolinesChildrenMalariaPharmacokineticsPiperaquine

Identifiers

PMID31795967
PMCPMC6889437
OpenAlexW2992601092

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.