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Completed

NCT Number: NCT03995680

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

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.

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Key information

Conditions

Hookworm Infections Ancylostomiasis Helminthiasis Infections Nematode Infections Parasitic Diseases Secernentea Infections Strongylida Infections

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Public Health Laboratory Ivo de Carneri

Chake Chake, Tanzania

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mebendazole

Drug

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Swiss Tropical & Public Health Institute

Other

Collaborators

  • Public Health Laboratory Ivo de Carneri

Registry information

Official study 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

Acronym: CHEW_MEB_PEMBA

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 24, 2019
Registry last updated
Jul 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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