Evidence map›Paper›PMID 29996844›Full record

Trial reportMalaria journal2018

Effectiveness and safety of 3 and 5 day courses of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in an area of emerging artemisinin resistance in Myanmar.

Kyaw Myo Tun, Atthanee Jeeyapant, Aung Hpone Myint, Zwe Thiha Kyaw, Mehul Dhorda, Mavuto Mukaka, Phaik Yeong Cheah, Mallika Imwong, Thaung Hlaing, Thar Htun Kyaw and 5 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Malaria journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02020330 (An Open-label Randomized Controlled Trial to Evaluate the Effectiveness and Safety of a 3 Day Versus 5 Day Course of Artemether-lumefantrine for the Treatment of Uncomplicated Falciparum Malaria in Myanmar), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 6% 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.

NCT02020330 phase3completednot on this map

An Open-label Randomized Controlled Trial to Evaluate the Effectiveness and Safety of a 3 Day Versus 5 Day Course of Artemether-lumefantrine for the Treatment of Uncomplicated Falciparum Malaria in Myanmar

TypeinterventionalSponsorUniversity of OxfordRan2013 to 2015Enrolled150ConditionsPlasmodium Falciparum InfectionArmsArtemether-lumefantrine 3 days, Artemether-lumefantrine 5 days
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Review
  15. Review
  16. Observational
  17. Article
  18. Origin and Spread of Evolving Artemisinin-ResistantThe American journal of tropical medicine and hygiene · 2019
    Review
  19. 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

15 authors at 5 institutions in 3 countries.

Kyaw Myo TunDefence Services Medical Academy, Yangon, Myanmar. myo.kyaw.tun@gmail.com.
Atthanee JeeyapantCentre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.
Aung Hpone MyintMyanmar Oxford Clinical Research Unit, Yangon, Myanmar.
Zwe Thiha KyawMyanmar Oxford Clinical Research Unit, Yangon, Myanmar.
Mehul DhordaCentre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.
Mavuto MukakaCentre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.
Phaik Yeong CheahCentre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.
Mallika ImwongMahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Thaung HlaingDepartment of Health, Ministry of Health and Sports, Naypyidaw, Myanmar.
Thar Htun KyawDepartment of Health, Ministry of Health and Sports, Naypyidaw, Myanmar.
Elizabeth A AshleyMyanmar Oxford Clinical Research Unit, Yangon, Myanmar.
Arjen DondorpCentre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.
Nicholas J WhiteCentre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.
Nicholas P J DayCentre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.
Frank SmithuisMyanmar Oxford Clinical Research Unit, Yangon, Myanmar.
Myanmar Oxford Clinical Research Unit · MMMahidol Oxford Tropical Medicine Research Unit · THMahidol University · THUniversity of Oxford · GBMinistry of Health and Sports · MM

Funding

Wellcome Trust
6 · The paper itself

Abstract

backgroundArtemisinin resistance in Plasmodium falciparum has emerged and spread in Southeast Asia. In areas where resistance is established longer courses of artemisinin-based combination therapy have improved cure rates.

methodsThe standard 3-day course of artemether-lumefantrine (AL) was compared with an extended 5-day regimen for the treatment of uncomplicated falciparum malaria in Kayin state in South-East Myanmar, an area of emerging artemisinin resistance. Late parasite clearance dynamics were described by microscopy and quantitative ultra-sensitive PCR. Patients were followed up for 42 days.

resultsOf 154 patients recruited (105 adults and 49 children < 14 years) 78 were randomized to 3 days and 76 to 5 days AL. Mutations in the P. falciparum kelch13 propeller gene (k13) were found in 46% (70/152) of infections, with F446I the most prevalent propeller mutation (29%; 20/70). Both regimens were well-tolerated. Parasite clearance profiles were biphasic with a slower submicroscopic phase which was similar in k13 wild-type and mutant infections. The cure rates were 100% (70/70) and 97% (68/70) in the 3- and 5-day arms respectively. Genotyping of the two recurrences was unsuccessful.

conclusionDespite a high prevalence of k13 mutations, the current first-line treatment, AL, was still highly effective in this area of South-East Myanmar. The extended 5 day regimen was very well tolerated, and would be an option to prolong the useful therapeutic life of AL. Trial registration NCT02020330. Registered 24 December 2013, https://clinicaltrials.gov/NCT02020330.

Indexed as

AdolescentAdultAntimalarialsArtemether, Lumefantrine Drug CombinationChildChild, PreschoolDrug ResistanceFemaleHumansInfantMalaria, FalciparumMaleMiddle AgedMutationMyanmarPlasmodium falciparumAntimalarialsArtemether, Lumefantrine Drug CombinationProtozoan ProteinsArtemether–lumefantrineArtemisinin resistancekelch13 mutationMyanmarPlasmodium falciparum

Identifiers

PMID29996844
PMCPMC6042398
OpenAlexW2824999272

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.