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

NCT03995680 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CHEW_MEB
• Study Type: interventional
• Target: 397
• Locations: 1 country
• Sites: 1

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.

Conditions

Hookworm Infections

Keywords

Mebendazole; Chewable tablet; Hookworm; Soil-transmitted helminths; Efficacy; Safety; Acceptability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Cure Rate (CR) of Mebendazole Against Hookworm

  Baseline (before treatment) and sometime between 14 and 21 days post-treatment

• CR of Both Mebendazole Regimens Against Trichuris Trichiura

  Baseline (before treatment) and sometime between 14 and 21 days post-treatment

• Geometric ERR of Both Mebendazole Formulations Against Trichuris Trichiura

  Baseline (before treatment) and sometime between 14 and 21 days post-treatment

• CR of Both Mebendazole Formulations Against Ascaris Lumbricoides

  Baseline (before treatment) and sometime between 14 and 21 days post-treatment

• Geometric ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides.

  Baseline (before treatment) and sometime between 14 and 21 days post-treatment

Study Arms (2)

Chewable tablet of mebendazole

EXPERIMENTAL

* 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

Swallowable tablet of mebendazole

ACTIVE COMPARATOR

* 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

Interventions

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.

Chewable tablet of mebendazole; Swallowable tablet of mebendazole

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• Public Health Laboratory Ivo de Carneri: collaborator

Study Sites (1)

Public Health Laboratory Ivo de Carneri

Chake Chake, Tanzania

Location

Related Publications (1)

• 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.

  PMID: 33150325 DERIVED

MeSH Terms

Conditions

Hookworm Infections; Ancylostomiasis

Interventions

Mebendazole

Condition Hierarchy (Ancestors)

Strongylida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Jennifer Keiser
• Organization: Swiss Tropical and Public Health Institute

jennifer.keiser@swisstph.ch

+41612848218

Study Officials

• Jennifer Keiser, PhD

  Swiss Tropical & Public Health Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 24, 2019
• Study Start: July 12, 2019
• Primary Completion: October 9, 2019
• Study Completion: October 9, 2019
• Last Updated: July 20, 2020
• Results First Posted: July 20, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)