Evidence map›Paper›PMID 32046718›Full record

Trial reportMalaria journal2020

Usefulness of day 7 lumefantrine plasma concentration as a predictor of malaria treatment outcome in under-fives children treated with artemether-lumefantrine in Tanzania.

Manase Kilonzi, Omary Minzi, Ritah Mutagonda, Vito Baraka, Philip Sasi, Eleni Aklillu, Appolinary Kamuhabwa

Open access · goldAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Malaria journal, 2020. 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
0.5field-weighted citation impact, top 30% 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, 5 citations in OpenAlex.

  1. Article
  2. Review
  3. 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

7 authors at 3 institutions in 2 countries.

Manase KilonziDepartment of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. BOX 65013, Dar es Salaam, Tanzania. manasekilonzi@yahoo.com.ORCID http://orcid.org/0000-0002-5355-8353
Omary MinziDepartment of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. BOX 65013, Dar es Salaam, Tanzania.
Ritah MutagondaDepartment of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. BOX 65013, Dar es Salaam, Tanzania.
Vito BarakaDepartment of Research, National Institute of Medical Research, Tanga Centre, P O Box 5004, Tanga, Tanzania.
Philip SasiDepartment of Clinical Pharmacology, School of Medicine, Muhimbili University of Health and Allied Sciences, P. O. BOX 6515, Dar es Salaam, Tanzania.
Eleni AklilluDivision of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital-Huddinge, C1:68, SE-141 86, Stockholm, Sweden.
Appolinary KamuhabwaDepartment of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. BOX 65013, Dar es Salaam, Tanzania.
Muhimbili University of Health and Allied Sciences · TZKarolinska University Hospital · SENational Institute for Medical Research · TZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDay 7 plasma lumefantrine concentration is suggested as a predictor for malaria treatment outcomes and a cut-off of ≥ 200 ng/ml is associated with day 28 cure rate in the general population. However, day 7 lumefantrine plasma concentration can be affected by age, the extent of fever, baseline parasitaemia, and bodyweight. Therefore, this study assessed the usefulness of day 7 lumefantrine plasma concentration as a predictor of malaria treatment outcome in under-fives children treated with generic or innovator drug-containing artemether-lumefantrine (ALu) in Tanzania.

methodsThis study was nested in an equivalence prospective study that aimed at determining the effectiveness of a generic ALu (Artefan

resultsThe PCR corrected cure rates were 98.7% for children treated with generic and 98.6% for those treated with the innovator product (p = 1.00). The geometric mean (± SD) of day 7 plasma lumefantrine concentration was 159.3 (± 2.4) ng/ml for the generic and 164 (± 2.5) ng/ml for the innovator groups, p = 0.87. Geometric mean (± SD) day 7 lumefantrine plasma concentration between cured and recurrent malaria was not statistically different in both treatment arms [158.5 (± 2.4) vs 100.0 (± 1.5) ng/ml, (p = 0.28) for generic arm and 158.5 (± 2.3) vs 251.2 (± 4.2) ng/ml, (p = 0.24) for innovator arm]. Nutritional status was found to be a determinant of recurrent malaria (adjusted hazardous ratio (95% confidence interval) = 3(1.1-8.2), p = 0.029.

conclusionUsing the recommended cut-off point of ≥ 200 ng/ml, day 7 plasma lumefantrine concentration failed to predict malaria treatment outcome in children treated with ALu in Tanzania. Further studies are recommended to establish the day 7 plasma lumefantrine concentration cut-off point to predict malaria treatment outcome in children.

Indexed as

Age FactorsAntimalarialsArtemether, Lumefantrine Drug CombinationBody WeightChild, PreschoolFemaleHemoglobinsHumansInfantLinear ModelsLumefantrineMalariaMaleNutritional StatusParasitemiaPolymerase Chain ReactionAntimalarialsArtemether, Lumefantrine Drug CombinationHemoglobinsLumefantrineArtemether-lumefantrineDay 7 plasma lumefantrine concentrationGenericInnovatorUncomplicated Plasmodium falciparum

Identifiers

PMID32046718
PMCPMC7014606
OpenAlexW3012824360

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.