Hookworm infection Infections and Infestations Hookworm infection
Conditions
Interventions
Current interventions as of 25/07/2017:
Single, oral tribendimidine 100, 200 and 400 mg and placebo.
Patients will be randomized using block randomization to one of fo
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 representative; and oral assent by child 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, severe anemia, clinical malaria 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 tribendimidine 9. Age range is 6-12 years old
Exclusion criteria
Exclusion criteria: 1. No written informed consent by parents and/or legal representative 2. Presence of major systemic illnesses, e.g. diabetes, severe anemia, clinical malaria 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 |
|---|---|
| Cure rate (conversion from being egg positive pre-treatment to egg negative post-treatment) against hookworm infection will be assessed using the quadruple Kato-Katz method at 21 days post-treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Egg reduction rate against hookworm infection will be assessed using the quadruple Kato-Katz method at 21 days post-treatment 2. Cure and egg reduction rate against concomitant soil-transmitted helminths will be assessed using the quadruple Kato-Katz method at 21 days post-treatment 3. Safety will be assessed with evaluation of adverse events of the treated subjects based on interviews at 3 and 24 hours after treatment 4. Pharmacokinetic parameters: drug concentrations will be measured with a validated LC/MS method at baseline, 2, 3, 4, 5, 6, 7, 7.5, 8.5 and 24 hours post-dosing | — |
Countries
Cote d'Ivoire
Outcome results
None listed