Albendazole-oxantel, albendazole-ivermectin, albendazole-mebendazole, and mebendazole in the treatment of whipworm infections

Not Applicable

Completed

Conditions: Trichuriasis
Infections and Infestations

Registration Number: ISRCTN80245406

Lead Sponsor: Swiss Tropical and Public Health Institute (Switzerland)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 440

Inclusion Criteria

1. Written informed consent signed by parents and/or legal guardian; and oral assent by children (aged 6-14 years)
2. Able and willing to be examined by a study physician and answer a questionnaire about signs and symptoms at the beginning of the study, 3 weeks and 3 months after treatment
3. Able and willing to provide two stool samples at the beginning of the study, 3 weeks and 3 months after treatment
4. Able and willing to provide a urine sample and a finger prick blood sample before treatment and 3 months after treatment
5. Positive for T. trichiura (presence of eggs in stool) at the baseline parasitology survey
6. Absence of major systemic illnesses (e.g. clinical malaria or hepato-splenic schistosomiasis) as assessed by a medical doctor, upon initial clinical assessment
7. No known or reported history of chronic illness such as cancer, diabetes, heart, liver or renal disease
8. No known allergy to study medications

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 drugs (within the past 4 weeks)
5. Attending other clinical trials during the study
6. Negative diagnostic result for T. trichiura (absence of eggs in stool) at baseline parasitological survey

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy (cure rate and egg reduction rate) against T. trichiura

Secondary Outcome Measures

Name	Time	Method
1. Adverse events observed with study drugs (before treatment, 2 and 24 hours after treatment).<br>2. The effect of the three drug combinations on infections with S. stercoralis, A. lumbricoides, A. duodenale, N. americanus. (Effect will be measured as reduction of eggs per gram of faeces [A. lumbricoides, A. duodenale, N. americanus] or if living larvae disappear after treatment from stool sample [S. stercoralis]. Measured at baseline and 3 weeks after treatment).<br>3. The clinical benefit of the tested drug combinations based on history of self-reported signs and symptoms, physical examination, and hemoglobin levels. (Measured at baseline [physical examination, questionnaire about general health using the visual analogue scale, and finger prick blood samples], 3 weeks after treatment [questionnaire about general health using the visual analogue scale], 3 months after treatment [physical examination, questionnaire about general health using the visual analogue scale, and finger prick blood samples].