Evidence map›Paper›PMID 19948038›Full record

Trial reportMalaria journal2009

Safety and tolerability of artemether-lumefantrine versus dihydroartemisinin-piperaquine for malaria in young HIV-infected and uninfected children.

Shereen Katrak, Anne Gasasira, Emmanuel Arinaitwe, Abel Kakuru, Humphrey Wanzira, Victor Bigira, Taylor G Sandison, Jaco Homsy, Jordan W Tappero, Moses R Kamya and 1 more

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Malaria journal, 2009. 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 20 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 4 pooled it
3.6field-weighted citation impact, top 8% 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.

NCT00527800 phase3completednot on this map

Interactions Between HIV and Malaria in African Children

TypeinterventionalSponsorUniversity of California, San FranciscoRan2007 to 2013Enrolled351ConditionsMalaria, HIV InfectionsArmsDihydroartemisinin-piperaquine, Artemether-lumefantrine, Trimethoprim-sulfamethoxazole
NCT02610400 phase3completednot on this mapstarted 2016, after this paper: background citation

Targeted Parasite Elimination in the Human and Mosquito to Reduce Malaria Transmission: A Cluster Randomised Controlled Factorial Design Trial of Reactive Focal Drug Administration (rfMDA) Versus Reactive Case Detection (RACD), With and Without Reactive Vector Control (RAVC), From the Low Endemic Setting of Namibia

TypeinterventionalSponsorUniversity of California, San FranciscoRan2016 to 2017Enrolled9,845ConditionsMalariaArmsRACD, RAVC, rfMDA
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 4 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
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  8. Artemisinin-based combination therapies are efficacious and safe for treatment of uncomplicated malaria in HIV-infected Ugandan children.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2014
    Trial
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  11. Trial
  12. Trial
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. In vitro metabolism of piperaquine is primarily mediated by CYP3A4.Xenobiotica; the fate of foreign compounds in biological systems · 2012
    Article
  19. PEPFAR scale-up of pediatric HIV services: innovations, achievements, and challenges.Journal of acquired immune deficiency syndromes (1999) · 2012
    Review
  20. Unresolved antiretroviral treatment management issues in HIV-infected children.Journal of acquired immune deficiency syndromes (1999) · 2012
    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

11 authors at 7 institutions in 2 countries.

Shereen KatrakOregon Health and Science University, Portland, USA. katraks@ohsu.edu
Anne Gasasira
Emmanuel Arinaitwe
Abel Kakuru
Humphrey Wanzira
Victor Bigira
Taylor G Sandison
Jaco Homsy
Jordan W Tappero
Moses R Kamya
Grant Dorsey
University of California, San Francisco · USCenters for Disease Control and Prevention · USMakerere University · UGMUJHU Research Collaboration · UGOregon Health & Science University · USUniversity of San Francisco · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundArtemisinin combination therapy has become the standard of care for uncomplicated malaria in most of Africa. However, there is limited data on the safety and tolerability of these drugs, especially in young children and patients co-infected with HIV.

methodsA longitudinal, randomized controlled trial was conducted in a cohort of HIV-infected and uninfected children aged 4-22 months in Tororo, Uganda. Participants were randomized to treatment with artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DP) upon diagnosis of their first episode of uncomplicated malaria and received the same regimen for all subsequent episodes. Participants were actively monitored for adverse events for 28 days and then passively for up to 63 days after treatment. This study was registered in ClinicalTrials.gov (registration # NCT00527800).

resultsA total of 122 children were randomized to AL and 124 to DP, resulting in 412 and 425 treatments, respectively. Most adverse events were rare, with only cough, diarrhoea, vomiting, and anaemia occurring in more than 1% of treatments. There were no differences in the risk of these events between treatment groups. Younger age was associated with an increased risk of diarrhoea in both the AL and DP treatment arms. Retreatment for malaria within 17-28 days was associated with an increased risk of vomiting in the DP treatment arm (HR = 6.47, 95% CI 2.31-18.1, p < 0.001). There was no increase in the risk of diarrhoea or vomiting for children who were HIV-infected or on concomitant therapy with antiretrovirals or trimethoprim-sulphamethoxazole prophylaxis.

conclusionBoth AL and DP were safe and well tolerated for the treatment of uncomplicated malaria in young HIV-infected and uninfected children.

trial registrationClinicalTrials.gov: NCT00527800; http://clinicaltrials.gov/ct2/show/NCT00527800.

Indexed as

AntimalarialsArtemetherArtemether, Lumefantrine Drug CombinationArtemisininsDrug CombinationsDrug Therapy, CombinationEthanolaminesFemaleFluorenesFollow-Up StudiesHIV InfectionsHumansInfantLongitudinal StudiesMalaria, FalciparumMaleAntimalarialsArtemetherArtemether, Lumefantrine Drug CombinationArtemisininsartenimolDrug CombinationsEthanolaminesFluorenespiperaquinePiperazinesQuinolines

Identifiers

PMID19948038
PMCPMC2789094
OpenAlexW2097922420

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.