Doxycycline treatment to eliminate Onchocerca volvulus worms that respond poorly to ivermecti

Not Applicable

Completed

• Conditions: Onchocerciasis (river blindness); Infections and Infestations; Onchocerciasis

• Registration Number: ISRCTN66649839
• Lead Sponsor: European Commission (Belgium)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-13
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

1. Males and females between 18 - 50 years
2. Good general health without any clinical condition requiring long-term medication
3. Clinical manifestation of onchocerciasis assessed by skin biopsies and palpation (at least one onchocercoma)
4. Minimum body weight 40 kg

Exclusion Criteria

1. Pregnancy (if not obvious all women are tested by dipstick chemistry: beta-human chorionic gonadotropin [BhCG])
2. Currently breast-feeding
3. Evidence of clinically significant neurological, cardiac, pulmonary, hepatic, rheumatological, or renal disease by history, physical examination, and/or laboratory tests
4. Behavioural, cognitive or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study protocol
5. Laboratory evidence of liver disease (aspartate aminotransferase [AST], alanine aminotransferase [ALT] and/or gamma-glutamyl transferase (GGT) greater than 1.25 times the upper limit of normal of the testing laboratory)
6. Laboratory evidence of renal disease (serum creatinine greater than 1.25 times the upper limit of normal of the testing laboratory)
7. Other condition that, in the opinion of the investigator, would jeopardise the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol
8. Volunteer has abused alcohol or illicit drugs during the past 6 months by history
9. History of severe allergic reaction or anaphylaxis
10. Intolerance to doxycycline

Study & Design

• Study Type: Interventional
• Study Design: Not specified