Efficacy and Safety of a Multi-dose Regimen of Mebendazole Against Hookworm in Children
Hookworm
About this trial
This is an interventional treatment trial for Hookworm
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
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).
Sites / Locations
- Public Health Laboratory Ivo de Carneri, P.O. Box 122
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Single dose of mebendazole
Multiple dose of mebendazole
In day 1 each child in this treatment arm will receive a 500 mg tablet of mebendazole plus one 100 mg placebo tablet in the morning. In the afternoon of day 1 they will only receive the placebo. In day 2 and 3 each child will receive one placebo twice a day (in the morning and in the evening)
In day 1 each child in this treatment arm will receive a 100 mg tablet of mebendazole plus one 500 mg placebo tablet in the morning. In the afternoon of day 1 they will only receive the 100 mg tablet of mebendazole. In day 2 and 3 each child will receive one 100 mg tablet of mebendazole twice a day (in the morning and in the evening).