Efficacy and safety of moxidectin alone and in combination against Trichuris trichiura infection: a randomised controlled trial

Phase 2

Completed

• Conditions: Infection with Trichuris trichiura and other soil-transmitted helminths; Infections and Infestations

• Registration Number: ISRCTN20398469
• Lead Sponsor: Swiss Tropical and Public Health Institute

Brief Summary

2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29858149 2020 results in https://pubmed.ncbi.nlm.nih.gov/33008301/ (added 07/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-28
• Study Completion: 2017-12-31
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

1. Written informed consent signed by participants (if 18 years old), parents and/or legal guardian; and oral assent by participants
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 one and 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 organ failure) as assessed by a 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 treatments (within past 2 months)
8. No known allergy to study medications
9. Age 12-18 years

Exclusion Criteria

1. No written informed consent by participants, 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 past 2 months)
5. Attending other clinical trials during the study
6. Negative diagnostic result for T. trichiura eggs in stool samples
7. Age below 12 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified