Trichuriasis Infections and Infestations
Conditions
Interventions
Sponsors
Eligibility
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 of the study 3. Able and willing to provide two stool samples at the beginning (baseline) and approximately three weeks after treatment (follow-up) 4. Positive for T. trichiura eggs in the 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 chronical illness 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 (absence of helminth eggs in stool)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cure rate (CR) and egg reduction rate (ERR) against T. trichiura: 14-21 days post-treatment 2. Safety/adverse events: 3 hours and 24 hours post-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| CR and ERR against A. lumbricoides and hookworms | — |
Countries
Tanzania