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

Swiss Tropical and Public Health (TPH) Institute

Status and phase: Completed; Phase 2

Conditions: Hookworm Infections

Treatments: Drug: Mebendazole

Study type: Interventional

Funder types: Other

Identifiers

NCT03995680

CHEW_MEB

Details and patient eligibility

About

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.

Enrollment: 397 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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397 participants in 2 patient groups

Chewable tablet of mebendazole

Experimental group

Description:

* 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;

Treatment:

Drug: Mebendazole

Swallowable tablet of mebendazole

Active Comparator group

Description:

* 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.

Treatment:

Drug: Mebendazole