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| Name | Class |
|---|---|
| Public Health Laboratory Ivo de Carneri | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chewable tablet of mebendazole | Experimental |
|
|
| Swallowable tablet of mebendazole | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (before treatment) and sometime between 14 and 21 days post-treatment |
| CR of Both Mebendazole Regimens Against Trichuris Trichiura |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Keiser, PhD | Swiss Tropical & Public Health Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Health Laboratory Ivo de Carneri | Chake Chake | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33150325 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chewable Tablet of Mebendazole | A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm. 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. |
| FG001 | Swallowable Tablet of Mebendazole | A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chewable Tablet of Mebendazole | A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm. 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | 95% Confidence Interval | percentage change in hookworm egg counts | Baseline (before treatment) and sometime between 14 and 21 days post-treatment |
|
3 hours and 24 hours post-treatment
Physicians and nurses actively questioned each child for adverse events using a questionnaire
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chewable Tablet of Mebendazole | A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Keiser | Swiss Tropical and Public Health Institute | +41612848218 | jennifer.keiser@swisstph.ch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 26, 2019 | Jun 15, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 24, 2018 | Jun 15, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006725 | Hookworm Infections |
| D000724 | Ancylostomiasis |
| ID | Term |
|---|---|
| D017206 | Strongylida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
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| ID | Term |
|---|---|
| D008463 | Mebendazole |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Baseline (before treatment) and sometime between 14 and 21 days post-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). | Baseline (before treatment) and sometime between 14 and 21 days post-treatment |
| 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. | Baseline (before treatment) and sometime between 14 and 21 days post-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). | Baseline (before treatment) and sometime between 14 and 21 days post-treatment |
| 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). | Baseline (before treatment) and sometime between 14 and 21 days post-treatment |
| 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). | Baseline (before treatment) and sometime between 14 and 21 days post-treatment |
| 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). | Baseline (before treatment) and sometime between 14 and 21 days post-treatment |
| Swallowable Tablet of Mebendazole |
A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Hemoglobin | Mean | Standard Deviation | grams per liter |
|
| OG001 | Swallowable Tablet of Mebendazole | A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm. 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. |
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (before treatment) and sometime between 14 and 21 days post-treatment |
|
|
|
| Secondary | 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. | Posted | Number | percentage of participants | Baseline (before treatment) and sometime between 14 and 21 days post-treatment |
|
|
|
| Secondary | 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). | Posted | Number | 95% Confidence Interval | percentage change in T. trich egg counts | Baseline (before treatment) and sometime between 14 and 21 days post-treatment |
|
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| Secondary | 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. | Posted | Number | percentage of participants | Baseline (before treatment) and sometime between 14 and 21 days post-treatment |
|
|
|
| Secondary | 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). | Posted | Number | percentage change in A. lumbr egg counts | Baseline (before treatment) and sometime between 14 and 21 days post-treatment |
|
|
|
| Secondary | 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). | Posted | Number | 95% Confidence Interval | percentage change in hookworm egg counts | Baseline (before treatment) and sometime between 14 and 21 days post-treatment |
|
|
|
| Secondary | 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). | Posted | Number | percentage change in T. trich egg counts | Baseline (before treatment) and sometime between 14 and 21 days post-treatment |
|
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|
| Secondary | 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). | Posted | Number | percentage change in A. lumbr egg counts | Baseline (before treatment) and sometime between 14 and 21 days post-treatment |
|
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|
| 0 |
| 197 |
| 0 |
| 197 |
| 14 |
| 197 |
| EG001 | Swallowable Tablet of Mebendazole | A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm. 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. | 0 | 196 | 0 | 196 | 15 | 196 |
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| D010272 |
| Parasitic Diseases |
| D007239 | Infections |
| D001562 |
| Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |