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NCT03995680: CHEW_MEB_PEMBA

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

Completed Phase 2 Results posted Last updated 20 July 2020
What this trial tests

Phase 2 trial testing Mebendazole in Hookworm Infections in 397 participants. Completed in 9 October 2019.

Timeline
12 July 2019
Primary endpoint
9 October 2019
9 October 2019

Quick facts

Lead sponsorSwiss Tropical & Public Health Institute
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment397
Start date12 July 2019
Primary completion9 October 2019
Estimated completion9 October 2019
Sites1 location across Tanzania

Drugs / interventions tested

Conditions studied

Sponsor

Swiss Tropical & Public Health Institute

Who can join

Adults 3 to 12, any sex, with Hookworm Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations of Mebendazole Against Hookworm Primary · 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).

GroupValue95% CI
Chewable Tablet of Mebendazole68.560.4 – 75.3
Swallowable Tablet of Mebendazole70.863.5 – 76.7
Cure Rate (CR) of Mebendazole Against Hookworm Secondary · 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.

GroupValue95% CI
Chewable Tablet of Mebendazole12.78.4 – 18.2
Swallowable Tablet of Mebendazole11.27.2 – 16.5
CR of Both Mebendazole Regimens Against Trichuris Trichiura Secondary · 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.

GroupValue95% CI
Chewable Tablet of Mebendazole9.8
Swallowable Tablet of Mebendazole7.3
Geometric ERR of Both Mebendazole Formulations Against Trichuris Trichiura Secondary · 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).

GroupValue95% CI
Chewable Tablet of Mebendazole73.365.7 – 79.4
Swallowable Tablet of Mebendazole74.267.2 – 79.8
CR of Both Mebendazole Formulations Against Ascaris Lumbricoides Secondary · 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.

GroupValue95% CI
Chewable Tablet of Mebendazole95.3
Swallowable Tablet of Mebendazole97.8
Geometric ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides. Secondary · 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).

GroupValue95% CI
Chewable Tablet of Mebendazole99.9
Swallowable Tablet of Mebendazole99.9
Arithmetic ERR of the Two Formulations of Mebendazole Against Hookworm Secondary · 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).

GroupValue95% CI
Chewable Tablet of Mebendazole38.226.6 – 47.8
Swallowable Tablet of Mebendazole28.18.5 – 44.3
Arithmetic ERR of Both Mebendazole Formulations Against Trichuris Trichiura Secondary · 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).

GroupValue95% CI
Chewable Tablet of Mebendazole52.9
Swallowable Tablet of Mebendazole50.9
Arithmetic ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides Secondary · 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).

GroupValue95% CI
Chewable Tablet of Mebendazole98.7
Swallowable Tablet of Mebendazole99.8

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 hours and 24 hours post-treatment. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Chewable Tablet of Mebendazole
Serious: 0/197 (0%)
Deaths: 0/197
Swallowable Tablet of Mebendazole
Serious: 0/196 (0%)
Deaths: 0/196
Other adverse events (1 terms — click to expand)

ReactionSystemChewable Tablet of Mebenda…Swallowable Tablet of Mebe…
Abdominal painGeneral disorders

Data from ClinicalTrials.gov NCT03995680 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Diagnosis of soil-transmitted helminths using the Kato-Katz technique: What is the influence of stirring, storage time and storage temperature on stool sample egg counts?
    Bosch F, Palmeirim MS, Ali SM, Ame SM, et al · · 2021 · cited 43× · PMID 33481808 · DOI 10.1371/journal.pntd.0009032
  2. Efficacy, safety and acceptability of a new chewable formulation <i>versus</i> the solid tablet of mebendazole against hookworm infections in children: An open-label, randomized controlled trial.
    Palmeirim MS, Bosch F, Ame SM, Ali SM, et al · · 2020 · cited 12× · PMID 33150325 · DOI 10.1016/j.eclinm.2020.100556
  3. Evaluation of two communication tools, slideshow and theater, to improve participants' understanding of a clinical trial in the informed consent procedure on Pemba Island, Tanzania.
    Palmeirim MS, Mohammed UA, Ross A, Ame SM, et al · · 2021 · cited 3× · PMID 33989324 · DOI 10.1371/journal.pntd.0009409

Verify or expand the search:

Other trials of Mebendazole

Trials testing the same drug.

Other recruiting trials for Hookworm Infections

Currently open trials in the same condition.

Other Swiss Tropical & Public Health Institute trials

Trials by the same sponsor.

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