Evidence map›Paper›PMID 30885157›Full record

ArticleBMC infectious diseases2019

Efficacy and safety of ivermectin and albendazole co-administration in school-aged children and adults infected with Trichuris trichiura: study protocol for a multi-country randomized controlled double-blind trial.

Chandni Patel, Eveline Hürlimann, Ladina Keller, Jan Hattendorf, Somphou Sayasone, Said M Ali, Shaali M Ame, Jean T Coulibaly, Jennifer Keiser

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03527732 (Efficacy and Safety of Ivermectin and Albendazole Co-administration in School-aged Children and Adults Infected With Trichuris Trichiura), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
3.8field-weighted citation impact, top 7% 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.

NCT03527732 phase2 / phase3completednot on this map

Efficacy and Safety of Ivermectin and Albendazole Co-administration in School-aged Children and Adults Infected With Trichuris Trichiura: a Multi-country Randomized Controlled Trial

TypeinterventionalSponsorJennifer KeiserRan2018 to 2020Enrolled1,673ConditionsTrichuriasisArmsAlbendazole, Albendazole and Ivermectin
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 32 citations in OpenAlex.

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  15. Whipworm and roundworm infections.Nature reviews. Disease primers · 2020
    Review
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

9 authors at 2 institutions in 3 countries.

Chandni PatelSwiss Tropical and Public Health Institute, Basel, Switzerland.
Eveline HürlimannSwiss Tropical and Public Health Institute, Basel, Switzerland.
Ladina KellerSwiss Tropical and Public Health Institute, Basel, Switzerland.
Jan HattendorfSwiss Tropical and Public Health Institute, Basel, Switzerland.
Somphou SayasoneSwiss Tropical and Public Health Institute, Basel, Switzerland.
Said M AliPublic Health Laboratory Ivo de Carneri, Chake Chake, Zanzibar, Pemba, Tanzania.
Shaali M AmePublic Health Laboratory Ivo de Carneri, Chake Chake, Zanzibar, Pemba, Tanzania.
Jean T CoulibalySwiss Tropical and Public Health Institute, Basel, Switzerland.
Jennifer KeiserSwiss Tropical and Public Health Institute, Basel, Switzerland. jennifer.keiser@swisstph.ch.ORCID http://orcid.org/0000-0003-0290-3521
Swiss Tropical and Public Health Institute · CHPublic Health Laboratory Ivo de Carneri · TZ

Funding

Bill and Melinda Gates Foundation OPP1153928
6 · The paper itself

Abstract

backgroundSoil-transmitted helminthiasis affects almost 2 billion people worldwide in tropical climates. Preventive chemotherapy, using the benzimidazoles (albendazole and mebendazole) is the current main recommended control strategy. Nevertheless, there is limited efficacy of these drugs against hookworm infection and, to a greater extent, against trichuriasis. We describe a protocol for a trial investigating the efficacy and safety of the co-administration of ivermectin and albendazole against trichuriasis.

methodsA double-blind, placebo-controlled randomized controlled trial will be conducted in three countries (Côte d'Ivoire, Tanzania and Lao PDR) with the aim to determine the efficacy, safety and extended effects of co-administered ivermectin and albendazole compared to standard albendazole monotherapy. We will enroll 600 participants aged 6-60 years in each setting. The primary outcome is cure rate (CR) against Trichuris trichiura infection as assessed by Kato-Katz 14-21 days after treatment. Secondary outcomes include CRs against concomitant soil-transmitted helminth (STH) infections (Ascaris lumbricoides, hookworm and Strongyloides stercoralis) and egg reduction rates (ERRs) against STH at 14-21 days, 180 days and 360 days. Tolerability of treatment, infection status assessed by polymerase chain reaction (PCR), and potential benefits of deworming on nutritional and morbidity indicators will be assessed. The primary analysis will include an available-case set and use logistic regression models adjusted for age, sex and weight. DISCUSSION: This trial will provide robust results on the efficacy and safety of co-administration of ivermectin and albendazole with the aim to better inform WHO recommendations on control of STHs. Furthermore, secondary and explanatory outcomes will provide direct evidence on the extended effects of combination therapy and insight on the relationship between nutrition and morbidity parameters and infection status and intensity.

trial registrationNCT03527732 (date assigned: 17 May 2018).

Indexed as

TrichurisAdolescentAdultAlbendazoleAnimalsAnthelminticsChildDouble-Blind MethodDrug Therapy, CombinationFemaleHumansIvermectinLogistic ModelsMaleMiddle AgedRandomized Controlled Trials as TopicAlbendazoleAnthelminticsIvermectinAlbendazoleCôte d’IvoireDrug efficacyDrug safetyIvermectinLao PDRSoil-transmitted helminthiasisTanzaniaTrichuris trichiura

Identifiers

PMID30885157
PMCPMC6421712
OpenAlexW2924377613

What OpenQuestion holds

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LicenceCC BY
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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.