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

Hookworm Infections Clinical Trial

— CHEW_MEB_PEMBA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995680
• Other study ID #: CHEW_MEB
• Status: Completed
• Phase: Phase 2
• Start date: July 12, 2019
• Est. completion date: October 9, 2019

Study information

• Verified date: July 2020
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: October 9, 2019
• Est. primary completion date: October 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hookworm Infections
• Infection

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Tanzania	Public Health Laboratory Ivo de Carneri	Chake Chake

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Tropical & Public Health Institute	Public Health Laboratory Ivo de Carneri

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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