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

Primary Purpose

Hookworm Infections

Status
Completed
Phase
Phase 2
Locations
Tanzania
Study Type
Interventional
Intervention
Mebendazole
Sponsored by
Swiss Tropical & Public Health Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hookworm Infections focused on measuring Mebendazole, Chewable tablet, Hookworm, Soil-transmitted helminths, Efficacy, Safety, Acceptability

Eligibility Criteria

3 Years - 12 Years (Child)All SexesAccepts 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.

Sites / Locations

  • Public Health Laboratory Ivo de Carneri

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chewable tablet of mebendazole

Swallowable tablet of mebendazole

Arm 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;

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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).
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.
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).
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).
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).
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).

Full Information

First Posted
May 30, 2019
Last Updated
July 17, 2020
Sponsor
Swiss Tropical & Public Health Institute
Collaborators
Public Health Laboratory Ivo de Carneri
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1. Study Identification

Unique Protocol Identification Number
NCT03995680
Brief Title
Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 12, 2019 (Actual)
Primary Completion Date
October 9, 2019 (Actual)
Study Completion Date
October 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swiss Tropical & Public Health Institute
Collaborators
Public Health Laboratory Ivo de Carneri

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hookworm Infections
Keywords
Mebendazole, Chewable tablet, Hookworm, Soil-transmitted helminths, Efficacy, Safety, Acceptability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
397 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chewable tablet of mebendazole
Arm Type
Experimental
Arm 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;
Arm Title
Swallowable tablet of mebendazole
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Mebendazole
Intervention Description
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.
Primary Outcome Measure Information:
Title
Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations of Mebendazole Against Hookworm
Description
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).
Time Frame
Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Secondary Outcome Measure Information:
Title
Cure Rate (CR) of Mebendazole Against Hookworm
Description
Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Time Frame
Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Title
CR of Both Mebendazole Regimens Against Trichuris Trichiura
Description
Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Time Frame
Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Title
Geometric ERR of Both Mebendazole Formulations Against Trichuris Trichiura
Description
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).
Time Frame
Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Title
CR of Both Mebendazole Formulations Against Ascaris Lumbricoides
Description
Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Time Frame
Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Title
Geometric ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides.
Description
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).
Time Frame
Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Title
Arithmetic ERR of the Two Formulations of Mebendazole Against Hookworm
Description
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).
Time Frame
Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Title
Arithmetic ERR of Both Mebendazole Formulations Against Trichuris Trichiura
Description
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).
Time Frame
Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Title
Arithmetic ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides
Description
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).
Time Frame
Baseline (before treatment) and sometime between 14 and 21 days post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Keiser, PhD
Organizational Affiliation
Swiss Tropical & Public Health Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Public Health Laboratory Ivo de Carneri
City
Chake Chake
Country
Tanzania

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33150325
Citation
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.
Results Reference
derived

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

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