Phase 2
N=397
Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm
Hookworm Infections
Bottom Line
View on ClinicalTrials.gov: NCT03995680 ↗Enrolled (actual)
397
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations of Mebendazole Against Hookworm — 68.5; 70.8 percentage change in hookworm egg counts
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mebendazole (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Swiss Tropical & Public Health Institute
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations of Mebendazole Against Hookworm |
68.5; 70.8 | — |
| SECONDARY Cure Rate (CR) of Mebendazole Against Hookworm |
12.7; 11.2 | — |
| SECONDARY CR of Both Mebendazole Regimens Against Trichuris Trichiura |
9.8; 7.3 | — |
| SECONDARY Geometric ERR of Both Mebendazole Formulations Against Trichuris Trichiura |
73.3; 74.2 | — |
| SECONDARY CR of Both Mebendazole Formulations Against Ascaris Lumbricoides |
95.3; 97.8 | — |
| SECONDARY Geometric ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides. |
99.9; 99.9 | — |
| SECONDARY Arithmetic ERR of the Two Formulations of Mebendazole Against Hookworm |
38.2; 28.1 | — |
| SECONDARY Arithmetic ERR of Both Mebendazole Formulations Against Trichuris Trichiura |
52.9; 50.9 | — |
| SECONDARY Arithmetic ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides |
98.7; 99.8 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03995680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.