Evidence map›Paper›PMID 37721964›Full record

Trial reportPLoS neglected tropical diseases2023

Safety and tolerability of moxidectin and ivermectin combination treatments for lymphatic filariasis in Côte d'Ivoire: A randomized controlled superiority study.

Catherine M Bjerum, Benjamin G Koudou, Allassane F Ouattara, Daphne Lew, Charles W Goss, Pascal T Gabo, Christopher L King, Peter U Fischer, Gary J Weil, Philip J Budge

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in PLoS neglected tropical diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04410406 (A Clinical Trial to Assess the Safety and Efficacy of Moxidectin Combination Treatments vs. Ivermectin Combination Treatments for Bancroftian Filariasis), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 14% 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.

NCT04410406 phase3completednot on this map

A Clinical Trial to Assess the Safety and Efficacy of Moxidectin Combination Treatments vs. Ivermectin Combination Treatments for Bancroftian Filariasis

TypeinterventionalSponsorWashington University School of MedicineRan2020 to 2024Enrolled164ConditionsLymphatic FilariasisArmsIvermectin, Diethylcarbamazine, Albendazole, Moxidectin
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Review
  6. 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 4 institutions in 2 countries.

Catherine M BjerumCenter for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio, United States of America.ORCID 0000-0002-1008-1866
Benjamin G KoudouUniversité Nangui Abrogoua, Abidjan, Côte d'Ivoire.
Allassane F OuattaraUniversité Nangui Abrogoua, Abidjan, Côte d'Ivoire.
Daphne LewDivision of Biostatistics, Washington University School of Medicine, St. Louis, Missouri, United States of America.
Charles W GossDivision of Biostatistics, Washington University School of Medicine, St. Louis, Missouri, United States of America.
Pascal T GaboCentre Hospitalier Régional d'Agboville, Agboville, Côte d'Ivoire.
Christopher L KingCenter for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio, United States of America.
Peter U FischerInfectious Diseases Division, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, United States of America.
Gary J WeilInfectious Diseases Division, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, United States of America.
Philip J BudgeInfectious Diseases Division, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, United States of America.
Washington University in St. Louis · USUniversité Nangui Abrogoua · CICenter for Global Health · USVeterans Health Administration · US

Funding

IMPROVED ANTIGEN DETECTION TESTS FOR FILARIAL INFECTIONSK08AI121422 · NIAID · WASHINGTON UNIVERSITY · PI BUDGE, PHILIP · 2016 to 2020
$856k
NIAID NIH HHS K08 AI121422
6 · The paper itself

Abstract

backgroundMoxidectin is a macrocyclic lactone registered for the treatment of human onchocerciasis. The drug has a good safety profile, large volume of distribution and a long elimination half-life. This paper reports tolerability data from the first use of moxidectin in persons with Wuchereria bancrofti infection.

methodsIn this randomized, open-label, masked-observer superiority trial, adults with Wuchereria bancrofti microfilaremia in Côte d'Ivoire were randomized to 1 of 4 treatment arms: ivermectin + albendazole (IA), moxidectin + albendazole (MoxA), ivermectin + diethylcarbamazine (DEC) + albendazole (IDA), or moxidectin + DEC + albendazole (MoxDA). As part of a larger efficacy trial, all participants were closely monitored for 7 days after treatment.

resultsOne hundred sixty-four individuals were treated, and monitored for treatment emergent adverse events (TEAE). Eighty-seven participants (53%) experienced one or more mild (grade 1) or moderate (grade 2) TEAE. Four participants had transient Grade 3 hematuria after treatment (3 after IDA and 1 after IA). There were no serious adverse events. There were no significant differences in frequency or types of TEAE between treatment groups (IA = 22/41 (53%), MoxA = 24/40 (60%), IDA = 18/41 (44%), MoxDA = 15/42 (36%), p = 0.530). Fifty-nine participants (36%) had multiple TEAE, and 8.5% had a one or more grade 2 (moderate) TEAE. Grade 2 TEAE were more frequent after triple drug treatments (IDA, 14.6%; MoxDA, 9.5%) than after two-drug treatments (IA, 7.3%; MoxA, 2.5%). There was no difference in TEAEs based on baseline Mf counts (OR 0.69 (0.33, 1.43), p-value 0.319).

conclusionAll treatment regimens were well tolerated. We observed no difference in safety parameters between regimens that contained ivermectin or moxidectin.

trial registrationClinicaltrials.gov, NCT04410406.

Indexed as

Elephantiasis, FilarialFilaricidesAdultAlbendazoleAnimalsCote d'IvoireDiethylcarbamazineDrug Therapy, CombinationHumansIvermectinMacrolidesWuchereria bancroftiAlbendazoleDiethylcarbamazineFilaricidesIvermectinMacrolidesmoxidectin

Identifiers

PMID37721964
PMCPMC10538700
OpenAlexW4386825715

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.