Evidence map›Paper›PMID 26732683›Full record

Trial reportMalaria journal2016

Pharmacokinetics of mefloquine and its effect on sulfamethoxazole and trimethoprim steady-state blood levels in intermittent preventive treatment (IPTp) of pregnant HIV-infected women in Kenya.

Michael Green, Kephas Otieno, Abraham Katana, Laurence Slutsker, Simon Kariuki, Peter Ouma, Raquel González, Clara Menendez, Feiko ter Kuile, Meghna Desai

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Malaria journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.7field-weighted citation impact, top 17% 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

2 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. 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 5 institutions in 4 countries.

Michael GreenDivision of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Center for Global Health, Atlanta, GA, USA. MGreen@cdc.gov.
Kephas OtienoKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya. kotieno@kemricdc.org.
Abraham KatanaKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya. wvf0@cdc.gov.
Laurence SlutskerDivision of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Center for Global Health, Atlanta, GA, USA. lms5@cdc.gov.
Simon KariukiKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya. skariuki@kemricdc.org.
Peter OumaKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya. pouma@kemricdc.org.
Raquel GonzálezISGlobal, Barcelona Ctr Int Health Res. (CRESIB), Hospital Clínic, Universitat de Barcelona, Barcelona, Spain. raquel.gonzalez@cresbo.cat.
Clara MenendezISGlobal, Barcelona Ctr Int Health Res. (CRESIB), Hospital Clínic, Universitat de Barcelona, Barcelona, Spain. menendez@clinic.ub.es.
Feiko ter KuileLiverpool School of Tropical Medicine, Liverpool, UK. Feiko.terkuile@lstmed.ac.uk.
Meghna DesaiDivision of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Center for Global Health, Atlanta, GA, USA. mud8@cdc.gov.
Kenya Medical Research Institute · KECenters for Disease Control and Prevention · USUniversitat de Barcelona · ESCenter for Global Health · USLiverpool School of Tropical Medicine · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntermittent preventive treatment in pregnancy with sulfadoxine/pyrimethamine is contra-indicated in HIV-positive pregnant women receiving sulfamethoxazole/trimethoprim prophylaxis. Since mefloquine is being considered as a replacement for sulfadoxine/pyrimethamine in this vulnerable population, an investigation on the pharmacokinetic interactions of mefloquine, sulfamethoxazole and trimethoprim in pregnant, HIV-infected women was performed.

methodsA double-blinded, placebo-controlled study was conducted with 124 HIV-infected, pregnant women on a standard regimen of sulfamethoxazole/trimethoprim prophylaxis. Seventy-two subjects received three doses of mefloquine (15 mg/kg) at monthly intervals. Dried blood spots were collected from both placebo and mefloquine arms four to 672 h post-administration and on day 7 following a second monthly dose of mefloquine. A novel high-performance liquid chromatographic method was developed to simultaneously measure mefloquine, sulfamethoxazole and trimethoprim from each blood spot. Non-compartmental methods using a naïve-pooled data approach were used to determine mefloquine pharmacokinetic parameters.

resultsSulfamethoxazole/trimethoprim prophylaxis did not noticeably influence mefloquine pharmacokinetics relative to reported values. The mefloquine half-life, observed clearance (CL/f), and area-under-the-curve (AUC0→∞) were 12.0 days, 0.035 l/h/kg and 431 µg-h/ml, respectively. Although trimethoprim steady-state levels were not significantly different between arms, sulfamethoxazole levels showed a significant 53% decrease after mefloquine administration relative to the placebo group and returning to pre-dose levels at 28 days.

conclusionsAlthough a transient decrease in sulfamethoxazole levels was observed, there was no change in hospital admissions due to secondary bacterial infections, implying that mefloquine may have provided antimicrobial protection.

Indexed as

AdolescentAdultAntimalarialsDouble-Blind MethodFemaleHIV InfectionsHumansKenyaMalariaMaleMefloquinePregnancyPregnancy Complications, InfectiousPregnancy Complications, ParasiticSulfamethoxazoleTrimethoprimAntimalarialsMefloquineSulfamethoxazoleTrimethoprimTrimethoprim, Sulfamethoxazole Drug Combination

Identifiers

PMID26732683
PMCPMC4700759
OpenAlexW2224873763

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.