Hookworm infection Infections and Infestations Hookworm infection
Conditions
Sponsors
Swiss Tropical and Public Health Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent signed by parents and/or legal guardian; and 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 hookworm eggs in the stool 5. Absence of major systemic illnesses (e.g. diabetes, anemia) 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 (e.g. albendazole, mebendazole) 9. Aged 15-18 years
Exclusion criteria
Exclusion criteria: 1. No written informed consent by parents and/or legal guardian and assent for children 2. Presence of major systemic illnesses (e.g. diabetes, anemia) as assessed by a medical doctor, upon initial clinical assessment 3. History of acute or severe chronic disease 4. Recent use of anthelminthic drug (within past 4 weeks) 5. Attending other clinical trials during the study 6. Negative diagnostic result for hookworm eggs in the stool
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Egg-reduction rates against hookworm are measured calculating the mean reduction in egg-counts at follow-up (after 14-21 days) compared to baseline (based on quadruplicated Kato-Katz thick smears). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cure rate (CR) against hookworm is the percentage of children egg negative calculated at follow-up (14-21 days post treatment) based on a quadruplicated Kato-Katz thick smear 2. Cure rate (CR) and egg-reduction rate (ERR) against A. lumbricoides and T. trichiura are egg free children at follow-up (14-21 days post treatment based on a quadruplicated Kato-Katz thick smear) or the mean reduction in egg-counts at follow-up (after 14-21 days) compared to baseline (based on quadruplicated Kato-Katz thick smear) 3. Pharmacokinetic parameters are determined based on concentration of the different drugs measured 4. Safety is measured based on number of children reporting adverse events at the time points 3 and 24 hours post treatment using a standardized questionnaire | — |
Countries
Cote d'Ivoire, Tanzania
Outcome results
None listed