Assessing the efficacy and safety of albendazole, nitazoxanide and albendazole-nitazoxanide in the treatment of Trichuris trichiura and other Soil Transmitted Helminth infections in Pemba, Tanzania

Not Applicable

Completed

Conditions: Infection with soil-transmitted helminths (i.e. T. trichiura, A. lumbricoides, hookworms)
Infections and Infestations
Soil transmitted infection

Registration Number: ISRCTN83836427

Lead Sponsor: niversity of Basel (Switzerland)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 600

Inclusion Criteria

1. Written informed consent signed by parents and/or legal guardian
2. Male or female, aged 6 - 12 years
3. Able and willing to be examined by a study physician at the beginning and at the end of the study (3 weeks post-treatment)
4. Able and willing to provide 2 stool samples at the beginning and at the end of the study
5. Absence of major systemic illnesses (e.g. cancer, diabetes, clinical malaria or hepato-splenic schistosomiasis) as assessed by the medical doctor, upon initial clinical assessment
6. No known or reported history of chronic illness as cancer, diabetes, chronic heart, liver or renal disease
7. No recent anthelminthic treatment (within past 4 weeks)
8. No pregnancy

Exclusion Criteria

1. No written informed consent by parents/legal guardian and child
2. Presence of any abnormal medical condition, judged by the study physician
3. History of acute or severe chronic disease.(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. Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cure rates and egg reduction rates three weeks after treatment:<br>1. For diagnosis 2 stool samples will be collected before and after treatment<br>2. From each stool sample 2 Kato-Katz thick smears will be examined<br>3. Additionally 2g of stool will be preserved for later diagnosis with the FLOTAC technique and ether concentration method

Secondary Outcome Measures

Name	Time	Method
Adverse events due to specific treatment: <br>1. Participants will be monitored 1 hour after treatment<br>2. 24 hours after each day of treatment they will be asked with a standard questionnaire for adverse events