Clinical trial NCT03995680: Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm
Official title: Efficacy and Safety of a New Chewable Tablet of Mebendazole Versus the Swallowable, Standard Tablet of Mebendazole Against Hookworm Infections in Children: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hookworm Infections
Keywords: Mebendazole
Chewable tablet
Hookworm
Soil-transmitted helminths
Efficacy
Safety
Acceptability
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Public Health Laboratory Ivo de Carneri
First posted: 2019-06-24
Enrollment: 397
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The rational of this study is to provide evidence on the safety and efficacy of a new chewable tablet of mebendazole compared to the standard tablet in preschool- and school-aged children infected with hookworm.


Eligibility criteria: Inclusion Criteria:

* Male or female children aged between 3 and 12 years;
* Written informed consent signed by caregiver;
* Was examined by a study physician before treatment;
* Provided two stool samples at baseline;
* Hookworm EPG \> 100 and at least two Kato-Katz thick smears slides with more than one hookworm egg;

Exclusion Criteria:

* Pregnant;
* Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, such as can upon initial clinical assessment;
* Suffers from severe anemia (Hb \< 80 g/l);
* Received anthelminthic treatment or metronidazole within past four weeks.
* Attending other clinical trials during the study.

Primary outcomes:
measure: Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations of Mebendazole Against Hookworm
timeFrame: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Secondary outcomes:
measure: Cure Rate (CR) of Mebendazole Against Hookworm
timeFrame: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
measure: CR of Both Mebendazole Regimens Against Trichuris Trichiura
timeFrame: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
measure: Geometric ERR of Both Mebendazole Formulations Against Trichuris Trichiura
timeFrame: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
measure: CR of Both Mebendazole Formulations Against Ascaris Lumbricoides
timeFrame: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
measure: Geometric ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides.
timeFrame: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
measure: Arithmetic ERR of the Two Formulations of Mebendazole Against Hookworm
timeFrame: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
measure: Arithmetic ERR of Both Mebendazole Formulations Against Trichuris Trichiura
timeFrame: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
measure: Arithmetic ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides
timeFrame: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Other outcomes:
Locations:
city: Chake Chake
country: Tanzania
facility: Public Health Laboratory Ivo de Carneri
Study officials:
affiliation: Swiss Tropical & Public Health Institute
name: Jennifer Keiser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palmeirim MS, Bosch F, Ame SM, Ali SM, Hattendorf J, Keiser J. Efficacy, safety and acceptability of a new chewable formulation versus the solid tablet of mebendazole against hookworm infections in children: An open-label, randomized controlled trial. EClinicalMedicine. 2020 Sep 20;27:100556. doi: 10.1016/j.eclinm.2020.100556. eCollection 2020 Oct.