Evidence map›Paper›PMID 29281988›Full record

Trial reportBMC infectious diseases2017

Intravenous artesunate plus Artemisnin based Combination Therapy (ACT) or intravenous quinine plus ACT for treatment of severe malaria in Ugandan children: a randomized controlled clinical trial.

Pauline Byakika-Kibwika, Jane Achan, Mohammed Lamorde, Carine Karera-Gonahasa, Agnes N Kiragga, Harriet Mayanja-Kizza, Noah Kiwanuka, Sam Nsobya, Ambrose O Talisuna, Concepta Merry

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC infectious diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 17% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. 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

10 authors at 5 institutions in 4 countries.

Pauline Byakika-KibwikaDepartment of Medicine, College of Health Sciences, Makerere University, P. O. Box, 7072, Kampala, Uganda. pbyakika@gmail.com.ORCID 0000-0003-0757-1968
Jane AchanMedical Research Council Unit, Serekunda, The Gambia.
Mohammed LamordeInfectious Diseases Institute, Kampala, Uganda.
Carine Karera-GonahasaInfectious Diseases Institute, Kampala, Uganda.
Agnes N KiraggaInfectious Diseases Institute, Kampala, Uganda.
Harriet Mayanja-KizzaDepartment of Medicine, College of Health Sciences, Makerere University, P. O. Box, 7072, Kampala, Uganda.
Noah KiwanukaSchool of Public Health, Makerere University, Kampala, Uganda.
Sam NsobyaDepartment of Pathology, Makerere University, Kampala, Uganda.
Ambrose O TalisunaUniversity of Oxford-KEMRI-Wellcome Trust Programme, Nairobi, Kenya.
Concepta MerryInfectious Diseases Institute, Kampala, Uganda.
Infectious Diseases Institute · UGMakerere University · UGKenya Medical Research Institute · KEMRC Unit the Gambia · GMTrinity College Dublin · IE

Funding

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

Abstract

backgroundSevere malaria is a medical emergency associated with high mortality. Adequate treatment requires initial parenteral therapy for fast parasite clearance followed by longer acting oral antimalarial drugs for cure and prevention of recrudescence.

methodsIn a randomized controlled clinical trial, we evaluated the 42-day parasitological outcomes of severe malaria treatment with intravenous artesunate (AS) or intravenous quinine (QNN) followed by oral artemisinin based combination therapy (ACT) in children living in a high malaria transmission setting in Eastern Uganda.

resultsWe enrolled 300 participants and all were included in the intention to treat analysis. Baseline characteristics were similar across treatment arms. The median and interquartile range for number of days from baseline to parasite clearance was significantly lower among participants who received intravenous AS (2 (1-2) vs 3 (2-3), P < 0.001). Overall, 63.3% (178/281) of the participants had unadjusted parasitological treatment failure over the 42-day follow-up period. Molecular genotyping to distinguish re-infection from recrudescence was performed in a sample of 127 of the 178 participants, of whom majority 93 (73.2%) had re-infection and 34 (26.8%) had recrudescence. The 42 day risk of recrudescence did not differ with ACT administered. Adverse events were of mild to moderate severity and consistent with malaria symptoms.

conclusionIn this high transmission setting, we observed adequate initial treatment outcomes followed by very high rates of malaria re-infection post severe malaria treatment. The impact of recurrent antimalarial treatment on the long term efficacy of antimalarial regimens needs to be investigated and surveillance mechanisms for resistance markers established since recurrent malaria infections are likely to be exposed to sub-therapeutic drug concentrations. More strategies for prevention of recurrent malaria infections in the most at risk populations are needed.

trial registrationThe study was registered with the Pan African Clinical Trial Registry ( PACTR201110000321348 ).

Indexed as

Administration, IntravenousAntimalarialsArtemisininsArtesunateChild, PreschoolDrug Therapy, CombinationFemaleHumansInfantKaplan-Meier EstimateMalariaMaleQuinineRisk FactorsTreatment OutcomeUgandaAntimalarialsartemisininArtemisininsArtesunateQuinineArtemisinin combination therapyArtesunateQuinineRe-infectionSevere malaria

Identifiers

PMID29281988
PMCPMC5745850
OpenAlexW2775916874

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.