Evidence map›Paper›PMID 31107869›Full record

Trial reportPLoS neglected tropical diseases2019

Pharmacokinetics, safety, and efficacy of a single co-administered dose of diethylcarbamazine, albendazole and ivermectin in adults with and without Wuchereria bancrofti infection in Côte d'Ivoire.

Constant Edi, Catherine M Bjerum, Allassane F Ouattara, Yashpal S Chhonker, Louis K Penali, Aboulaye Méité, Benjamin G Koudou, Gary J Weil, Christopher L King, Daryl J Murry

3 registry-linked trialsOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in PLoS neglected tropical diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
3.8field-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.

NCT02845713 phase1completednot on this map

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Single Dose Treatment With Diethylcarbamazine, Albendazole and Ivermectin in Humans With and Without Wuchereria Bancrofti Infection in Côte d'Ivoire

TypeinterventionalSponsorUniversity Hospitals Cleveland Medical CenterRan2016 to 2016Enrolled66ConditionsWuchereria Bancrofti InfectionArmsIvermectin, Diethylcarbamazine Albendazole (IDA)
NCT04410406 phase3completednot on this mapstarted 2020, after this paper: background citation

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
NCT06070116 phase2active not recruitingnot on this mapstarted 2024, after this paper: background citation

Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis

TypeinterventionalSponsorWashington University School of MedicineRan2024 to 2026Enrolled300ConditionsOnchocercal Subcutaneous Nodule, Onchocerciasis, Onchocerciasis, Ocular, Onchocerca InfectionArmsIvermectin w/ Albendazole, Ivermectin + Diethylcarbamazine + Albendazole, Moxidectin + Albendazole, Moxidectin + Diethylcarbamazine + Albendazole
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 43 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

10 authors at 7 institutions in 3 countries.

Constant EdiCentre Suisse de Recherche Scientifique en Côte d'Ivoire, Côte d'Ivoire.
Catherine M BjerumCenter for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, OH, United States of America.
Allassane F OuattaraCentre Suisse de Recherche Scientifique en Côte d'Ivoire, Côte d'Ivoire.ORCID 0000-0002-3856-8406
Yashpal S ChhonkerDept of Pharmacy Practice, University of Nebraska Medical Center, Omaha, NE, United States of America.
Louis K PenaliInstitut Pasteur de Côte d'Ivoire, Côte d'Ivoire.
Aboulaye MéitéProgramme National de la Lutte Contre la Schistosomiase, les Geohelminthiases et la Filariose Lymphatique, Abidjan, Côte d'Ivoire.
Benjamin G KoudouCentre Suisse de Recherche Scientifique en Côte d'Ivoire, Côte d'Ivoire.
Gary J WeilInfectious Diseases Division, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, United States of America.
Christopher L KingCenter for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, OH, United States of America.ORCID 0000-0003-3873-7860
Daryl J MurryFred and Pamela Buffett Cancer Center, University of Nebraska Medical Center, Omaha, NE, United States of America.
Université Nangui Abrogoua · CIUniversity of Nebraska Medical Center · USCenter for Global Health · USInstitut Pasteur de Côte d'Ivoire · CISwiss Centre for Scientific Research · CIVeterans Health Administration · USWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA single co-administered dose of ivermectin (IVM) plus diethylcarbamazine (DEC) plus albendazole (ALB), or triple-drug therapy, was recently found to be more effective for clearing microfilariae (Mf) than standard DEC plus ALB currently used for mass drug administration programs for lymphatic filariasis (LF) outside of sub-Saharan Africa. Triple-drug therapy has not been previously tested in LF-uninfected individuals from Africa. This study evaluated the pharmacokinetics (PK), safety, and efficacy of triple-drug therapy in people with and without Wuchereria bancrofti infection in West Africa.

methodsIn this open-label cohort study, treatment-naïve microfilaremic (>50 mf/mL, n = 32) and uninfected (circulating filarial antigen negative, n = 24) adults residing in Agboville district, Côte d'Ivoire, were treated with a single dose of IVM plus DEC plus ALB, and evaluated for adverse events (AEs) until 7 days post treatment. Drug levels were assessed by liquid chromatography and mass spectrometry. Persons responsible for assessing AEs were blinded to participants' infection status.

findingsThere was no difference in AUC0-inf or Cmax between LF-infected and uninfected participants (P>0.05 for all comparisons). All subjects experienced mild AEs; 28% and 25% of infected and uninfected participants experienced grade 2 AEs, respectively. There were no severe or serious adverse events. Only fever (16 of 32 versus 4 of 24, P<0.001) and scrotal pain/swelling in males (6 of 20 versus 0 of 12, P = 0.025) were more frequent in infected than uninfected participants. All LF positive participants were amicrofilaremic at 7 days post-treatment and 27 of 31 (87%) remained amicrofilaremic 12 months after treatment.

conclusionsModerate to heavy W. bancrofti infection did not affect PK parameters for IVM, DEC or ALB following a single co-administered dose of these drugs compared to uninfected individuals. The drugs were well tolerated. This study confirmed the efficacy of the triple-drug therapy for clearing W. bancrofti Mf and has added important information to support the use of this regimen in LF elimination programs in areas of Africa without co-endemic onchocerciasis or loiasis.

trial registrationClinicalTrials.gov NCT02845713.

Indexed as

AdolescentAdultAgedAlbendazoleAnimalsCohort StudiesCote d'IvoireDiethylcarbamazineDrug CombinationsElephantiasis, FilarialFemaleFilaricidesHumansIvermectinMaleMiddle AgedAlbendazoleDiethylcarbamazineDrug CombinationsFilaricidesIvermectin

Identifiers

PMID31107869
PMCPMC6550417
OpenAlexW2946771710

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.