Trial · NCT03245398
Efficacy and Safety of a Multi-dose Regimen of Mebendazole Against Hookworm in Children
NCT03245398, Phase 4, Completed, Jennifer Keiser; results first posted 2019-06-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of a Multi-dose Regimen of Mebendazole Against Hookworm in Children. Trials, record NCT03245398. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03245398
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of a Multi-dose Regimen of Mebendazole Against Hookworm in Children
- NCT number
- NCT03245398
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 186 participants, actual
- Lead sponsor
- Jennifer Keiser
- Conditions
- Hookworm
- Interventions
- Treatment with one of the two regimens of mebendazole
- First posted
- 2017-08-10
- Last updated
- 2019-06-17
- Results first posted
- 2019-06-17
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cure Rate (CR) of Mebendazole Against Hookworm | baseline (before treatment) and 18 to 22 days post-treatment | Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Secondary | Geometric Mean Egg Reduction Rate (ERR) of the Two Regimens of Mebendazole Against Hookworm | baseline (before treatment) and 18 to 22 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 | CR of Both Mebendazole Regimens Against Trichuris Trichiura | baseline (before treatment) and 18 to 22 days post-treatment | Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Secondary | Geometric ERR of Both Mebendazole Regimens Against Trichuris Trichiura | baseline (before treatment) and 18 to 22 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 | Cure Rate (CR) of Both Mebendazole Regimens Against Ascaris Lumbricoides | baseline (before treatment) and 18 to 22 days post-treatment | Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Secondary | Geometric ERR of Both Mebendazole Regimens Against Ascaris Lumbricoides. | baseline (before treatment) and 18 to 22 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 | Arithmetic ERR of the Two Regimens of Mebendazole Against Hookworm | baseline (before treatment) and 18 to 22 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). |
| Secondary | Arithmetic ERR of Both Mebendazole Regimens Against Trichuris Trichiura | baseline (before treatment) and 18 to 22 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). |
| Secondary | Arithmetic ERR of Both Mebendazole Regimens Against Ascaris Lumbricoides | baseline (before treatment) and 18 to 22 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). |
| Other | Comparison of the Sensitivity of Kato Katz to Quantitative Polymerase Chain Reaction (PCR) Assays | 1 year | Two aliquots (about 1 g of stool each) of positive samples will be stored in ethanol and transported to the Swiss Tropical Public Health Institute for subsequent DNA extraction and diagnostic. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cure Rate (CR) of Mebendazole Against Hookworm | baseline (before treatment) and 18 to 22 days post-treatment | percentage of participants cured | NUMBER | |
| SECONDARY | Geometric Mean Egg Reduction Rate (ERR) of the Two Regimens of Mebendazole Against Hookworm | baseline (before treatment) and 18 to 22 days post-treatment | percentage change | GEOMETRIC_MEAN | |
| SECONDARY | CR of Both Mebendazole Regimens Against Trichuris Trichiura | baseline (before treatment) and 18 to 22 days post-treatment | percentage of participants cured | NUMBER | |
| SECONDARY | Geometric ERR of Both Mebendazole Regimens Against Trichuris Trichiura | baseline (before treatment) and 18 to 22 days post-treatment | percentage of change | MEAN | |
| SECONDARY | Cure Rate (CR) of Both Mebendazole Regimens Against Ascaris Lumbricoides | baseline (before treatment) and 18 to 22 days post-treatment | percentage of participants cured | NUMBER | |
| SECONDARY | Geometric ERR of Both Mebendazole Regimens Against Ascaris Lumbricoides. | baseline (before treatment) and 18 to 22 days post-treatment | percentage change | MEAN | |
| SECONDARY | Arithmetic ERR of the Two Regimens of Mebendazole Against Hookworm | baseline (before treatment) and 18 to 22 days post-treatment | percentage change | MEAN | |
| SECONDARY | Arithmetic ERR of Both Mebendazole Regimens Against Trichuris Trichiura | baseline (before treatment) and 18 to 22 days post-treatment | percentage change | MEAN | |
| SECONDARY | Arithmetic ERR of Both Mebendazole Regimens Against Ascaris Lumbricoides | baseline (before treatment) and 18 to 22 days post-treatment | percentage change | MEAN | |
| OTHER_PRE_SPECIFIED | Comparison of the Sensitivity of Kato Katz to Quantitative Polymerase Chain Reaction (PCR) Assays | 1 year |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cure Rate (CR) of Mebendazole Against Hookworm | Single 500 mg Dose of Mebendazole | 13 | 95% Confidence Interval 6.9 to 21.7 | percentage of participants cured | |
| Cure Rate (CR) of Mebendazole Against Hookworm | Multiple (Bid for 3 Days) Dose of 100 mg Mebendazole | 97.9 | 95% Confidence Interval 92.4 to 99.7 | percentage of participants cured | |
| Geometric Mean Egg Reduction Rate (ERR) of the Two Regimens of Mebendazole Against Hookworm | Single 500 mg Dose of Mebendazole | -68.0 | 95% Confidence Interval -78.6 to -51.5 | percentage change | |
| Geometric Mean Egg Reduction Rate (ERR) of the Two Regimens of Mebendazole Against Hookworm | Multiple (Bid for 3 Days) Dose of 100 mg Mebendazole | -100 | 95% Confidence Interval -100 to -99.9 | percentage change | |
| CR of Both Mebendazole Regimens Against Trichuris Trichiura | Single 500 mg Dose of Mebendazole | 6.8 | 95% Confidence Interval 4.6 to 17.8 | percentage of participants cured | |
| CR of Both Mebendazole Regimens Against Trichuris Trichiura | Multiple (Bid for 3 Days) Dose of 100 mg Mebendazole | 42.9 | 95% Confidence Interval 33.8 to 54.8 | percentage of participants cured | |
| Geometric ERR of Both Mebendazole Regimens Against Trichuris Trichiura | Single 500 mg Dose of Mebendazole | -71.7 | 95% Confidence Interval -78.5 to -56.7 | percentage of change | |
| Geometric ERR of Both Mebendazole Regimens Against Trichuris Trichiura | Multiple (Bid for 3 Days) Dose of 100 mg Mebendazole | -98.1 | 95% Confidence Interval -98.7 to -96.8 | percentage of change | |
| Cure Rate (CR) of Both Mebendazole Regimens Against Ascaris Lumbricoides | Single 500 mg Dose of Mebendazole | 100 | 95% Confidence Interval 100 to 100 | percentage of participants cured | |
| Cure Rate (CR) of Both Mebendazole Regimens Against Ascaris Lumbricoides | Multiple (Bid for 3 Days) Dose of 100 mg Mebendazole | 98 | 95% Confidence Interval 94.2 to 100 | percentage of participants cured |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Single 500 mg Dose of Mebendazole | 93 | |
| Overall Study | STARTED | Multiple (Bid for 3 Days) Dose of 100 mg Mebendazole | 93 | |
| Overall Study | COMPLETED | Single 500 mg Dose of Mebendazole | 92 | |
| Overall Study | COMPLETED | Multiple (Bid for 3 Days) Dose of 100 mg Mebendazole | 93 | |
| Overall Study | NOT COMPLETED | Single 500 mg Dose of Mebendazole | 1 | |
| Overall Study | NOT COMPLETED | Multiple (Bid for 3 Days) Dose of 100 mg Mebendazole | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Single 500 mg Dose of Mebendazole | 2 | 93 | |
| other | Abdominal pain | Gastrointestinal disorders | Multiple (Bid for 3 Days) Dose of 100 mg Mebendazole | 8 | 93 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single 500 mg Dose of Mebendazole | 0 | 93 |
| Total, all-cause mortality | Multiple (Bid for 3 Days) Dose of 100 mg Mebendazole | 0 | 93 |
| Total, other adverse events | Single 500 mg Dose of Mebendazole | 2 | 93 |
| Total, other adverse events | Multiple (Bid for 3 Days) Dose of 100 mg Mebendazole | 8 | 93 |
| Total, serious adverse events | Single 500 mg Dose of Mebendazole | 0 | 93 |
| Total, serious adverse events | Multiple (Bid for 3 Days) Dose of 100 mg Mebendazole | 0 | 93 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31193620 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Single 500 mg Dose of Mebendazole vs Multiple (Bid for 3 Days) Dose of 100 mg Mebendazole: deaths from any cause | Trial comparisons |
| Single 500 mg Dose of Mebendazole vs Multiple (Bid for 3 Days) Dose of 100 mg Mebendazole: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03245398
GET https://conductscience.org/api/trials/v1/NCT03245398/registered