T. trichiura or/and hookworm infections Infections and Infestations Hookworm disease, unspecified
Conditions
Interventions
Group 1:
Day 1: 20 mg/kg oxantel pamoate
Day 2: 1 albendazole tablet plus 1 mebendazole matching placebo
Group 2:
Day 1: 20 mg/kg oxantel pamoate
Day 2: 1 albendazole matching placebo plus 1 mebendazole matching placebo
Group 3:
Day 1: 20 mg/kg oxantel pamoate placebo
Day 2: 1 albendazole tablet plus 1 mebendazole matching placebo
Group 4:
Day 1: 20 mg/kg oxantel pamoate placebo
Day 2: 1 mebendazole tablet plus 1 albendazole matching placebo
Sponsors
Medicor Foundation (Liechtenstein)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent signed by parents and/or legal guardian; and oral assent by children 2. Able and willing to be examined by a study physician at the beginning and at the end of the study (3 weeks post-treatment) 3. Able and willing to provide two stool samples at the beginning and at the end of the study 4. Positive for T. trichiura or hookworm, or both STH concurrently (presence of helminth eggs in stool) 5. Absence of major systemic illnesses (e.g. cancer, diabetes, clinical malaria or hepato-splenic schistosomiasis) as assessed by a medical doctor, upon initial clinical assessment 6. No known or reported history of chronic illness such as cancer, diabetes, chronic heart, liver or renal disease 7. No recent anthelminthic treatment (within past 4 weeks) 8. No known allergy to study medications
Exclusion criteria
Exclusion criteria: 1. No written informed consent by parents and/or legal guardian 2. Presence of any abnormal medical condition, judged by the study physician 3. History of acute or severe chronic disease such as cancer, diabetes, chronic heart, liver or renal disease 4. Recent use of anthelminthic drug (within past 4 weeks) 5. Attending other clinical trials during the study 6. Negative diagnostic result for T. trichiura and/or hookworm (absence of helminth eggs in stool)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure rates and egg reduction rates 3 weeks after treatment. For diagnosis two stool samples will be collected before and after treatment. From each stool sample duplicate Kato-Katz thick smears will be examined. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events will be assessed 3 and 24 hours after each day of treatment. | — |
Countries
Tanzania
Outcome results
None listed