Evidence map›Paper›PMID 34296417›Full record

Trial reportClinical pharmacokinetics2022

Characterization of the Population Pharmacokinetics of Moxidectin in Adults Infected with Strongyloides Stercoralis: Support for a Fixed-Dose Treatment Regimen.

Cornelis Smit, Daniela Hofmann, Somphou Sayasone, Jennifer Keiser, Marc Pfister

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04056325 (Efficacy, Safety and Pharmacokinetics of Ascending Dosages of Moxidectin Alone and in Comparison to Ivermectin Against Strongyloides Stercoralis in Adults), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 24% 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.

NCT04056325 phase2 / phase3completednot on this map

Efficacy, Safety and Pharmacokinetics of Ascending Dosages of Moxidectin Alone and in Comparison to Ivermectin Against Strongyloides Stercoralis in Adults: a Randomized Controlled Trial

TypeinterventionalSponsorJennifer KeiserRan2019 to 2021Enrolled617ConditionsStrongyloides Stercoralis InfectionArmsMoxidectin, Ivermectin, Placebo oral tablet
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Strongyloidiasis.Nature reviews. Disease primers · 2024
    Review
  2. Review
  3. Review
  4. 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

5 authors at 2 institutions in 2 countries.

Cornelis Smit *Pediatric Pharmacology and Pharmacometrics Research, University of Basel Children's Hospital (UKBB), Spitalstrasse 33, 4056, Basel, Switzerland.ORCID 0000-0002-1357-9248
Daniela Hofmann *Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, University of Basel, Socinstrasse 57, 4051, Basel, Switzerland.
Somphou SayasoneDepartment of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, University of Basel, Socinstrasse 57, 4051, Basel, Switzerland.
Jennifer KeiserDepartment of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, University of Basel, Socinstrasse 57, 4051, Basel, Switzerland. jennifer.keiser@swisstph.ch.
Marc PfisterPediatric Pharmacology and Pharmacometrics Research, University of Basel Children's Hospital (UKBB), Spitalstrasse 33, 4056, Basel, Switzerland. marc.pfister@ukbb.ch.ORCID 0000-0003-2597-1228
Swiss Tropical and Public Health Institute · CHUniversity of Basel · CH

Funding

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung IZJFZ3_185646
6 · The paper itself

Abstract

backgroundMoxidectin has recently attracted attention as a novel candidate for the treatment of helminth infections, including Strongyloides stercoralis. This study aims to characterize the population pharmacokinetics (PPK) of moxidectin in S. stercoralis-infected adults using a pharmacometric approach, and to perform model-based simulations to explore different drug dosing strategies.

methodsA PPK study embedded in a dose-escalation phase IIa trial was conducted in NamBak, Laos. Eight micro blood samples were collected from each of 96 S. stercoralis-infected adults following a moxidectin dose-ranging study, from 2 to 12 mg. A PPK model was developed using nonlinear mixed-effects modeling, and dosing strategies were explored using simulations in S. stercoralis-infected subjects with varying age and body weight (n = 5000 per dosing strategy).

resultsA two-compartment model including delayed absorption with lag-time best described the available PK data. Allometric scaling was applied to account for the influence of body weight. High clearance was found in the infected adults (4.47 L/h [95% confidence interval 3.63-5.39] for a 70 kg individual) compared with that previously reported for healthy adults. Model-based simulations indicated similar variability in mean ± standard deviation area under the curve from time zero to infinity of 1907 ± 1552 and 2175 ± 1670 ng × h/mL in the 60-70 kg weight group, after 8 mg fixed- or weight-based dosing, respectively.

conclusionWe describe the first PPK model for moxidectin in adults with S. stercoralis infection. Equivalent exposures after fixed-dose and weight-dependent dosing strategies support the use of a simple fixed-dose approach, particularly in large-scale treatment programs.

trial registrationRegistered at ClinicalTrials.gov (NCT04056325).

Indexed as

Strongyloides stercoralisStrongyloidiasisAdultAnimalsHumansMacrolidesMacrolidesmoxidectin

Identifiers

PMID34296417
PMCPMC8761718
OpenAlexW3185658887

What OpenQuestion holds

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LicenceCC BY-NC
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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.