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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995680
Recruitment Status : Completed
First Posted : June 24, 2019
Last Update Posted : October 29, 2019
Sponsor:
Collaborator:
Public Health Laboratory Ivo de Carneri
Information provided by (Responsible Party):
Jennifer Keiser, 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.

Condition or disease Intervention/treatment Phase
Hookworm Infections Drug: Mebendazole Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 399 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 12, 2019
Actual Primary Completion Date : October 9, 2019
Actual Study Completion Date : October 9, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Mebendazole

Arm Intervention/treatment
Experimental: Chewable tablet of mebendazole
A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm.
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.

Active Comparator: Swallowable tablet of mebendazole
A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm.
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.




Primary Outcome Measures :
  1. Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations of Mebendazole Against Hookworm [ Time Frame: 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 :
  1. Cure Rate (CR) of Mebendazole Against Hookworm [ Time Frame: 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.

  2. CR of Both Mebendazole Regimens Against Trichuris trichiura [ Time Frame: 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.

  3. Geometric ERR of Both Mebendazole Formulations Against Trichuris Trichiura [ Time Frame: 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).

  4. CR of Both Mebendazole Formulations Against Ascaris lumbricoides [ Time Frame: 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.

  5. Geometric ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides. [ Time Frame: 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).

  6. Arithmetic ERR of the Two Formulations of Mebendazole Against Hookworm [ Time Frame: 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).

  7. Arithmetic ERR of Both Mebendazole Formulations Against Trichuris Trichiura [ Time Frame: 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).

  8. Arithmetic ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995680


Locations
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Tanzania
Public Health Laboratory Ivo de Carneri
Chake Chake, Tanzania
Sponsors and Collaborators
Swiss Tropical & Public Health Institute
Public Health Laboratory Ivo de Carneri
Investigators
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Principal Investigator: Jennifer Keiser, PhD Swiss Tropical & Public Health Institute
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Responsible Party: Jennifer Keiser, Prof. Dr., Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier: NCT03995680    
Other Study ID Numbers: CHEW_MEB_PEMBA
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Jennifer Keiser, Swiss Tropical & Public Health Institute:
Mebendazole
Chewable tablet
Hookworm
Soil-transmitted helminths
Efficacy
Safety
Acceptability
Additional relevant MeSH terms:
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Infection
Hookworm Infections
Ancylostomiasis
Strongylida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Mebendazole
Piperazine
Piperazine citrate
DMP 777
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors