Evidence map›Paper›PMID 34651190›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022

Safety and Efficacy of Levamisole in Loiasis: A Randomized, Placebo-controlled, Double-blind Clinical Trial.

Jérémy T Campillo, Paul Bikita, Marlhand Hemilembolo, Frédéric Louya, François Missamou, Sébastien D S Pion, Michel Boussinesq, CédricB Chesnais

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 13% 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

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 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

8 authors at 1 institution in 1 country.

Jérémy T CampilloUMI 233 TransVIHMI, Université de Montpellier, Institut de Recherche pour le Développement (IRD), INSERM Unité 1175, Montpellier, Franceand.ORCID 0000-0002-4400-5204
Paul BikitaProgramme National de Lutte contre l'Onchocercose, Direction de l'Épidémiologie et de la Lutte contre la Maladie, Ministère de la Santé et de la Population, Brazzaville, Republic of the Congo.
Marlhand HemilemboloProgramme National de Lutte contre l'Onchocercose, Direction de l'Épidémiologie et de la Lutte contre la Maladie, Ministère de la Santé et de la Population, Brazzaville, Republic of the Congo.
Frédéric LouyaProgramme National de Lutte contre l'Onchocercose, Direction de l'Épidémiologie et de la Lutte contre la Maladie, Ministère de la Santé et de la Population, Brazzaville, Republic of the Congo.
François MissamouProgramme National de Lutte contre l'Onchocercose, Direction de l'Épidémiologie et de la Lutte contre la Maladie, Ministère de la Santé et de la Population, Brazzaville, Republic of the Congo.
Sébastien D S PionUMI 233 TransVIHMI, Université de Montpellier, Institut de Recherche pour le Développement (IRD), INSERM Unité 1175, Montpellier, Franceand.
Michel BoussinesqUMI 233 TransVIHMI, Université de Montpellier, Institut de Recherche pour le Développement (IRD), INSERM Unité 1175, Montpellier, Franceand.
CédricB ChesnaisUMI 233 TransVIHMI, Université de Montpellier, Institut de Recherche pour le Développement (IRD), INSERM Unité 1175, Montpellier, Franceand.ORCID 0000-0002-8779-977X
Inserm · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIndividuals with high microfilarial densities (MFDs) of Loa loa are at risk of developing serious adverse events (SAEs) after ivermectin treatment. Pretreatment with drugs progressively reducing Loa MFDs below the risk threshold might help prevent these SAEs. We assessed the safety and efficacy of levamisole for this purpose.

methodsA double-blind, randomized, placebo-controlled, MFD-ascending trial was conducted in the Republic of the Congo. Participants were treated in 3 cohorts defined by pretreatment MFD and levamisole dose (cohort 1: 1.0kg and 1.5mg/kg; cohorts 2 and 3: 2.5mg/kg). Safety outcomes were occurrence of SAE and adverse event frequency during the first week. The efficacy outcomes were MFD reduction from baseline and proportions of individuals with at least 40% and 80% MFD reduction at day 2 (D2), D7, and D30.

resultsThe 2 lowest doses (1.0mg/kg and 1.5mg/kg) caused no SAEs but were ineffective. Compared with placebo, 2.5mg/kg levamisole caused more mild adverse events (10/85 vs. 3/85, P=.018), a higher median reduction from baseline to D2 (-12.9% vs. +15.5%, P<.001), D7 (-4.9% vs. +18.7%, P<.001), and D30 (-0.5% vs. +13.5%, P=.036) and a higher percentage of participants with >40% MFD reduction at D2 (17.5% vs. 1.2%, P<.001), D7 (11.8% vs. 6.3%, P=.269), and D30 (18.5% vs. 9.6%, P=.107).

conclusionsA single 2.5mg/kg levamisole dose induces a promising transient reduction in Loa loa MFDs and should encourage testing different regimens.

Indexed as

LoiasisAnimalsDouble-Blind MethodHumansIvermectinLevamisoleLoaMicrofilariaeIvermectinLevamisoleAfricaclinical trialfilariasislevamisoleloiasis

Identifiers

PMID34651190
PMCPMC9402607
OpenAlexW3205526109

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.