Evidence map›Paper›PMID 26666942›Full record

Trial reportAntimicrobial agents and chemotherapy2015

Artemether-Lumefantrine Pharmacokinetics and Clinical Response Are Minimally Altered in Pregnant Ugandan Women Treated for Uncomplicated Falciparum Malaria.

Myaing M Nyunt, Vy K Nguyen, Richard Kajubi, Liusheng Huang, Joshua Ssebuliba, Sylvia Kiconco, Moses W Mwima, Jane Achan, Francesca Aweeka, Sunil Parikh and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01717885 (Antimalarial Pharmacology in HIV Infected and Uninfected Children and Pregnant Women in Uganda), which is not on this map. Cited by 21 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 5 pooled it
4.0field-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.

NCT01717885 completednot on this map

Antimalarial Pharmacology in HIV Infected and Uninfected Children and Pregnant Women in Uganda

TypeobservationalSponsorUniversity of California, San FranciscoRan2012 to 2016Enrolled473ConditionsMalaria, HIV
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 5 syntheses or guidelines pooled it, 30 citations in OpenAlex.

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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 3 institutions in 2 countries.

Myaing M NyuntInstitute for Global Health, University of Maryland Baltimore School of Medicine, Baltimore, Maryland, USA.
Vy K NguyenDepartment of Clinical Pharmacy, University of California, San Francisco, San Francisco, California, USA.
Richard KajubiInfectious Disease Research Collaboration, Makerere University, Kampala, Uganda.
Liusheng HuangDepartment of Clinical Pharmacy, University of California, San Francisco, San Francisco, California, USA.
Joshua SsebulibaInfectious Disease Research Collaboration, Makerere University, Kampala, Uganda.
Sylvia KiconcoInfectious Disease Research Collaboration, Makerere University, Kampala, Uganda.
Moses W MwimaInfectious Disease Research Collaboration, Makerere University, Kampala, Uganda.
Jane AchanInfectious Disease Research Collaboration, Makerere University, Kampala, Uganda.
Francesca AweekaDepartment of Clinical Pharmacy, University of California, San Francisco, San Francisco, California, USA.
Sunil ParikhYale School of Public Health, New Haven, Connecticut, USA sunil.parikh@yale.edu mwebno@yahoo.com.
Norah MwebazaInfectious Disease Research Collaboration, Makerere University, Kampala, Uganda sunil.parikh@yale.edu mwebno@yahoo.com.
Makerere University · UGUniversity of California, San Francisco · USUniversity of Maryland, Baltimore · US

Funding

Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI STEVEN Grant DEEKS · 1988 to 2026
$93.6M
The immunologic consequences of prenatal exposure to malariaP01HD059454 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI HAVLIR, DIANE V · 2008 to 2017
$22.6M
Optimizing HIV-malaria treatment in a shifting treatment and resistance landscape in AfricaR01HD068174 · NICHD · YALE UNIVERSITY · PI FRANCESCA T. AWEEKA, SUNIL PARIKH · 2011 to 2026
$8.1M
Clinical and Transtional Science InstituteTL1TR000144 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANDIS, JENNIFER RUBIN · 2012 to 2015
$643k
NCATS NIH HHS TL1 TR000144NIAID NIH HHS P30 AI022763NIAID NIH HHS P30 AI027763NICHD NIH HHS P01 HD059454NICHD NIH HHS R01HD068174
6 · The paper itself

Abstract

Artemether-lumefantrine is a first-line regimen for the treatment of uncomplicated malaria during the second and third trimesters of pregnancy. Previous studies have reported changes in the pharmacokinetics and clinical outcomes following treatment with artemether-lumefantrine in pregnant women compared to nonpregnant adults; however, the results are inconclusive. We conducted a study in rural Uganda to compare the pharmacokinetics of artemether-lumefantrine and the treatment responses between 30 pregnant women and 30 nonpregnant adults with uncomplicated Plasmodium falciparum malaria. All participants were uninfected with HIV, treated with a six-dose regimen of artemether-lumefantrine, and monitored clinically for 42 days. The pharmacokinetics of artemether, its metabolite dihydroartemisinin, and lumefantrine were evaluated for 21 days following treatment. We found no significant differences in the overall pharmacokinetics of artemether, dihydroartemisinin, or lumefantrine in a direct comparison of pregnant women to nonpregnant adults, except for a statistically significant but small difference in the terminal elimination half-lives of both dihydroartemisinin and lumefantrine. There were seven PCR-confirmed reinfections (5 pregnant and 2 nonpregnant participants). The observation of a shorter terminal half-life for lumefantrine may have contributed to a higher frequency of reinfection or a shorter posttreatment prophylactic period in pregnant women than in nonpregnant adults. While the comparable overall pharmacokinetic exposure is reassuring, studies are needed to further optimize antimalarial efficacy in pregnant women, particularly in high-transmission settings and because of emerging drug resistance. (This study is registered at ClinicalTrials.gov under registration no. NCT01717885.).

Indexed as

AdolescentAdultAntimalarialsArtemetherArtemisininsCohort StudiesDrug Therapy, CombinationEthanolaminesFemaleFluorenesHumansLumefantrineMalaria, FalciparumMiddle AgedPregnancyPregnancy Complications, ParasiticAntimalarialsArtemetherArtemisininsartenimolEthanolaminesFluorenesLumefantrine

Identifiers

PMID26666942
PMCPMC4775973
OpenAlexW2286471707

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.