Evidence map›Paper›PMID 25133389›Full record

Trial reportPloS one2014

Efficacy and day 7 plasma piperaquine concentrations in African children treated for uncomplicated malaria with dihydroartemisinin-piperaquine.

Issaka Zongo, Fabrice A Somé, Serge A M Somda, Sunil Parikh, Noel Rouamba, Philip J Rosenthal, Joel Tarning, Niklas Lindegardh, François Nosten, Jean Bosco Ouédraogo

Open access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
1.9field-weighted citation impact, top 13% 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

17 citing papers in PubMed, 22 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Antimicrobial agents and chemotherapy · 2024
    Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Observational
  17. 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 6 institutions in 4 countries.

Issaka ZongoDirection Régionale de l'Ouest, Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.
Fabrice A SoméDirection Régionale de l'Ouest, Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.
Serge A M SomdaNon Transmissible disease department, Centre Muraz Bobo-Dioulasso, Bobo-Dioulasso, Burkina Faso.
Sunil ParikhDepartment of Medicine, Yale University School of Public Health, New Haven, Connecticut, United States of America.
Noel RouambaDirection Régionale de l'Ouest, Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.
Philip J RosenthalDepartment of Medicine, University of California San Francisco, San Francisco, California, United States of America.
Joel TarningMahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.
Niklas LindegardhMahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.
François NostenMahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand; Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.
Jean Bosco OuédraogoDirection Régionale de l'Ouest, Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso; Non Transmissible disease department, Centre Muraz Bobo-Dioulasso, Bobo-Dioulasso, Burkina Faso.
Institut de Recherche en Sciences de la Santé · BFUniversity of Oxford · GBCentre Muraz · BFMahidol University · THUniversity of California, San Francisco · USYale University · US

Funding

Wellcome Trust
6 · The paper itself

Abstract

backgroundOne promising new Artemisinin-based combination therapies (ACTs) is dihydroartemisinin-piperaquine (DHA-PQ). However, the pharmacokinetics of piperaquine and the relationship between drug levels and clinical efficacy are incompletely characterized, particularly in children.

methodsWe performed a single-arm open-label trial in Bobo-Dioulasso, Burkina Faso. A total of 379 participants aged 6 months or more with uncomplicated falciparum malaria were enrolled. Each participant received daily dose of DHA-PQ for three days and followed for 42 days. Parasitological efficacy was analyzed, considering rates of recrudescence and overall recurrence. PK was an exploratory endpoint and a priori, no sample size had been determined. Day 7 capillary and venous plasma concentrations of piperaquine were measured in children aged 2-10 years.

resultsOf the 379 participants, 365 (96.3%) completed 42 days of follow-up. The median daily dose of PQ was 18.5 mg/kg [6.5-24]. Treatment with DHA-PQ was well tolerated with fever and parasitemia resolution within 48 hours in nearly all children. Recurrent malaria within 42 days of follow-up occurred in 31.3% (10/34) of children less than 2 years old, 16.0% (16/106) of those aged 2-5 years, 9.4% (15/160) of those aged 5-10 years, and none (0/68) of those over 10 years old. After genotyping, 3 of 41 recurrent episodes were recrudescence. An exploratory analysis shows that children with successful treatment outcomes had significantly higher median plasma concentrations of PQ compared to those with recurrent malaria within 42 days after therapy, considering either capillary samples (68 ng/ml [50-85] compared to 48 ng/ml [36-55], p<0.001) or venous samples (42 ng/ml [29-59] compared to 25 ng/ml [19-44], p<0.001).

conclusionDHA-PQ was effective for uncomplicated P. falciparum malaria treatment and offers an alternative to other ACTs. Recurrent malaria was mainly due to new infections after treatment and was correlated with low day 7 PQ concentration in the youngest patients.

trial registrationControlled-Trials.com ISRCTN59761234.

Indexed as

AntimalarialsArtemisininsBurkina FasoChildChild, PreschoolDrug Administration ScheduleDrug CombinationsFemaleHumansInfantMalaria, FalciparumMalePiperazinesQuinolinesTreatment FailureAntimalarialsartemisininArtemisininsDrug CombinationspiperaquinePiperazinesQuinolines

Identifiers

PMID25133389
PMCPMC4136730
OpenAlexW2108216869

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.