Evidence map›Paper›PMID 29855373›Full record

Trial reportBMC medicine2018

Efficacy and safety of ascending doses of praziquantel against Schistosoma haematobium infection in preschool-aged and school-aged children: a single-blind randomised controlled trial.

Jean T Coulibaly, Gordana Panic, Richard B Yapi, Jana Kovač, Beatrice Barda, Yves K N'Gbesso, Jan Hattendorf, Jennifer Keiser

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 17% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 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 4 institutions in 2 countries.

Jean T CoulibalyDepartment of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, P.O. Box, CH-4002, Basel, Switzerland.
Gordana PanicDepartment of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, P.O. Box, CH-4002, Basel, Switzerland.
Richard B YapiCentre Suisse de Recherches Scientifiques, Abidjan, Côte d'Ivoire.
Jana KovačDepartment of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, P.O. Box, CH-4002, Basel, Switzerland.
Beatrice BardaDepartment of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, P.O. Box, CH-4002, Basel, Switzerland.
Yves K N'GbessoDepartement d'Agboville, Centre de Santé Urbain d'Azaguié, Azaguié, Côte d'Ivoire.
Jan HattendorfUniversity of Basel, Basel, Switzerland.
Jennifer KeiserDepartment of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, P.O. Box, CH-4002, Basel, Switzerland. jennifer.keiser@swisstph.ch.
Swiss Tropical and Public Health Institute · CHUniversity of Basel · CHSwiss Centre for Scientific Research · CIUniversité Félix Houphouët-Boigny · CI

Funding

European Research Council 614739H2020 European Research Council ERC-2013-CoG 614739-A_HERO
6 · The paper itself

Abstract

backgroundDespite decades of experience with praziquantel treatment in school-aged children (SAC) and adults, we still face considerable knowledge gaps relevant to the successful treatment of preschool-aged children (PSAC). This study aimed to assess the efficacy and safety of escalating praziquantel dosages in PSAC infected with Schistosoma haematobium.

methodsWe conducted a randomised, dose-finding trial in PSAC (2-5 years) and as comparator a cohort of SAC (6-15 years) infected with S. haematobium in Côte d'Ivoire. A total of 186 PSAC and 195 SAC were randomly assigned to 20, 40 or 60 mg/kg praziquantel or placebo. The nature of the dose-response relationship in terms of cure rate (CR) was the primary objective. Egg reduction rate (ERR) and tolerability were secondary outcomes. CRs and ERRs were assessed using triplicate urine filtration over 3 consecutive days. Available-case analysis was performed including all participants with primary endpoint data.

resultsA total of 170 PSAC and 174 SAC received treatment. Almost 90% of PSAC and three quarters of SAC were lightly infected with S. haematobium. Follow-up data were available for 157 PSAC and 166 SAC. In PSAC, CRs of praziquantel were 85.7% (30/35), 78.0% (32/41) and 68.3% (28/41) at 20, 40 and 60 mg/kg and 47.5% (19/40) for placebo. In SAC, CRs were 10.8% for placebo (4/37), 55.6% for 20 mg/kg (25/45), 68.3% for 40 mg/kg (28/41) and 60.5% for 60 mg/kg (26/43). ERRs based on geometric means ranged between 96.5% (60 mg/kg) and 98.3% (20 mg/kg) in PSAC and between 97.6% (20 mg/kg and 60 mg/kg) and 98.6% (40 mg/kg) in SAC. Adverse events were mild and transient.

conclusionsPraziquantel revealed dose-independent efficacy against light infections of S. haematobium. Over the dose range tested, praziquantel displayed a ceiling effect with the highest response for 20 mg/kg in PSAC. In SAC maximum efficacy was obtained with 40 mg/kg praziquantel. Further investigations are required in children with moderate to heavy infections.

trial registrationThis trial is registered with International Standard Randomised Controlled Trial Number ISRCTN15280205 .

Indexed as

AdolescentAnimalsAnthelminticsChildChild, PreschoolCohort StudiesFemaleHumansMalePraziquantelSchistosoma haematobiumSchistosomiasis haematobiaSingle-Blind MethodTreatment OutcomeAnthelminticsPraziquantelEfficacyPraziquantelPreschool-aged childrenSchistosoma haematobiumSchool-aged children

Identifiers

PMID29855373
PMCPMC5984412
OpenAlexW2805726927

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.