Status:
COMPLETED
Efficacy and Safety of a Multi-dose Regimen of Mebendazole Against Hookworm in Children
Lead Sponsor:
Jennifer Keiser
Collaborating Sponsors:
PATH
Public Health Laboratory Ivo de Carneri
Conditions:
Hookworm
Eligibility:
All Genders
6-12 years
Phase:
PHASE4
Brief Summary
This study is a double-blind randomized clinical trial which aims at providing evidence on the efficacy and safety of two regimens of mebendazole in school-aged children. Thus, our primary objective i...
Eligibility Criteria
Inclusion
- Written informed consent signed by parents and/or caregiver; and oral assent by participant.
- Able and willing to be examined by a study physician at the beginning of the study.
- Able and willing to provide two stool samples at the beginning (baseline) and approximately three weeks after treatment (follow-up).
- Positive for hookworm eggs in the stool (≥ 100 EPG and at least two Kato-Katz thick smears slides with more than one hookworm egg).
- Absence of major systemic illnesses, e.g. diabetes, severe anemia (HB\<8.0 g/l) as assessed by a medical doctor at school, upon initial clinical assessment.
- No known or reported history of chronical illness as cancer, diabetes, chronic heart, liver or renal disease.
- No recent anthelminthic treatment (within past 4 weeks). No known allergy to study medications (mebendazole and albendazole).
Exclusion
- No written informed consent by parents and/or caregiver; no oral assent by participant.
- Menarche, based on self-report
- Presence of major systemic illnesses, e.g. diabetes, severe anemia (HB\<8.0 g/l) as assessed by a medical doctor, upon initial clinical assessment.
- History of acute or severe chronic disease.
- Recent use of anthelminthic drug (within past 4 weeks).
- Attending other clinical trials during the study.
- Negative diagnostic result for hookworm eggs in the stool (\< 100 EPG (total of the four slides) and/or only one Kato-Katz thick smear slide with more than one hookworm egg).
Key Trial Info
Start Date :
July 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2017
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT03245398
Start Date
July 25 2017
End Date
September 15 2017
Last Update
June 17 2019
Active Locations (1)
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1
Public Health Laboratory Ivo de Carneri, P.O. Box 122
Chake Chake, Pemba, Tanzania