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

Phase 2

Completed

• Conditions: Hookworm Infections
• Interventions: Drug: Mebendazole

• Registration Number: NCT03995680
• Lead Sponsor: Swiss Tropical & Public Health Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-30
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-24
• Study Start: 2019-07-12
• Primary Completion: 2019-10-09
• Study Completion: 2019-10-09
• Results First Submitted: 2020-06-15
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-17
• Last Update Submitted: 2020-07-17
• Results First Posted: 2020-07-20
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 397

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chewable tablet of mebendazole	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;
Swallowable tablet of mebendazole	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.

Primary Outcome Measures

Name	Time	Method
Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations of Mebendazole Against Hookworm	Baseline (before treatment) and sometime between 14 and 21 days post-treatment	Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)\*100).

Secondary Outcome Measures

Name	Time	Method
CR of Both Mebendazole Regimens Against Trichuris Trichiura	Baseline (before treatment) and sometime between 14 and 21 days post-treatment	Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Geometric ERR of Both Mebendazole Formulations Against Trichuris Trichiura	Baseline (before treatment) and sometime between 14 and 21 days post-treatment	Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)\*100).
CR of Both Mebendazole Formulations Against Ascaris Lumbricoides	Baseline (before treatment) and sometime between 14 and 21 days post-treatment	Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Geometric ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides.	Baseline (before treatment) and sometime between 14 and 21 days post-treatment	Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)\*100).
Arithmetic ERR of the Two Formulations of Mebendazole Against Hookworm	Baseline (before treatment) and sometime between 14 and 21 days post-treatment	Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(arithmetic mean EPG at follow-up/arithmetic mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (arithmetic mean at follow-up/arithmetic mean at baseline)\*100).
Arithmetic ERR of Both Mebendazole Formulations Against Trichuris Trichiura	Baseline (before treatment) and sometime between 14 and 21 days post-treatment	Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(arithmetic mean EPG at follow-up/arithmetic mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (arithmetic mean at follow-up/arithmetic mean at baseline)\*100).
Arithmetic ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides	Baseline (before treatment) and sometime between 14 and 21 days post-treatment	Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(arithmetic mean EPG at follow-up/arithmetic mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (arithmetic mean at follow-up/arithmetic mean at baseline)\*100).
Cure Rate (CR) of Mebendazole Against Hookworm	Baseline (before treatment) and sometime between 14 and 21 days post-treatment	Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.

Trial Locations

Locations (1)

Public Health Laboratory Ivo de Carneri; 🇹🇿 Chake Chake, Tanzania