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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hookworm Infections

Intervention / Treatment
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* Drug: Mebendazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chewable tablet of mebendazole<br>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; | Drug: Mebendazole<br>* 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.<br>|
| Active Comparator: Swallowable tablet of mebendazole<br>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. | Drug: Mebendazole<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations of Mebendazole Against Hookworm | 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). | Baseline (before treatment) and sometime between 14 and 21 days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure Rate (CR) of Mebendazole Against Hookworm | Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | Baseline (before treatment) and sometime between 14 and 21 days post-treatment | 
| CR of Both Mebendazole Regimens Against Trichuris Trichiura | Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | Baseline (before treatment) and sometime between 14 and 21 days post-treatment | 
| Geometric ERR of Both Mebendazole Formulations Against Trichuris Trichiura | 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). | Baseline (before treatment) and sometime between 14 and 21 days post-treatment | 
| CR of Both Mebendazole Formulations Against Ascaris Lumbricoides | Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | Baseline (before treatment) and sometime between 14 and 21 days post-treatment | 
| Geometric ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides. | 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). | Baseline (before treatment) and sometime between 14 and 21 days post-treatment | 
| Arithmetic ERR of the Two Formulations of Mebendazole Against Hookworm | 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). | Baseline (before treatment) and sometime between 14 and 21 days post-treatment | 
| Arithmetic ERR of Both Mebendazole Formulations Against Trichuris Trichiura | 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). | Baseline (before treatment) and sometime between 14 and 21 days post-treatment | 
| Arithmetic ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides | 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). | Baseline (before treatment) and sometime between 14 and 21 days post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Mebendazole, Chewable tablet, Hookworm, Soil-transmitted helminths, Efficacy, Acceptability