Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm

NCT ID: NCT03995680

Last Updated: 2020-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 397 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-12
• Study Completion Date: 2019-10-09

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.

Conditions

Hookworm Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chewable tablet of mebendazole

• 3-5 year olds allocated to the swallowable tablet arm will be given the crushed tablet on a spoon mixed with a small amount of clean water;
• 6-12 year olds allocated to the swallowable tablet arm will be given the whole tablet to swallow with a glass of clean water;

Group Type: EXPERIMENTAL

Mebendazole

Intervention Type: DRUG

Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.

Swallowable tablet of mebendazole

• 3-5 year olds allocated to the chewable tablet arm will be encouraged to chew the tablet and swallow it without water; if they cannot chew it then a small amount of water will be added to the tablet in a spoon;
• 6-12 year olds allocated to the chewable tablet arm will be encouraged to chew the tablet and then swallow it without water.

Group Type: ACTIVE_COMPARATOR

Mebendazole

Intervention Type: DRUG

Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.

Interventions

Mebendazole

Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Public Health Laboratory Ivo de Carneri

OTHER

Sponsor Role: collaborator

Swiss Tropical & Public Health Institute

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Keiser

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Keiser, PhD

Role: PRINCIPAL_INVESTIGATOR

Swiss Tropical & Public Health Institute

Locations

Public Health Laboratory Ivo de Carneri

Chake Chake, , Tanzania

Countries

Tanzania

References

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.

Reference Type: DERIVED

PMID: 33150325 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CHEW_MEB

Identifier Type: -

Identifier Source: org_study_id