Comparison of doxycycline alone vs doxycycline plus rifampicin in their efficacy against onchocerciasis

Not Applicable

Completed

• Conditions: Onchocerciasis (Onchocerca volvulus); Infections and Infestations; Onchocerciasis

• Registration Number: ISRCTN68861628
• Lead Sponsor: iverpool School of Tropical Medicine (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-21
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Men and women between 18-55 years
2. Good general health without any clinical condition requiring long-term medication and with normal renal and hepatic laboratory profiles
3. Body weight (BW): 40-70 kg
4. Presence of at least 1 palpable onchocercoma

Exclusion Criteria

1. Known intolerance to the study drugs (doxycycline, rifampicin)
2. Pregnancy (if not obvious, all women are tested by dipstick chemistry (ß-hCG), the test will be carried out pre-treatment and every 2 weeks during treatment)
3. Currently breast-feeding
4. History of severe allergic reaction or anaphylaxis
5. History of alcohol or drug abuse
6. Evidence of clinically significant neurological, cardiac, pulmonary, hepatic, metabolic, rheumatologic or renal disease as assessed by history of participants, physical examination, and/or laboratory examinations including blood and urine analyses
7. Laboratory evidence of liver disease (alanine aminotransferase [ALT], gamma-GT greater than 1.25 times the upper limit of normal results as stated by the manufacturer of dipstick tests, Roche)
8. Laboratory evidence of renal disease (serum creatinine greater than 1.25 times the upper limit of normal results as stated by the manufacturer of dipstick tests, Roche)
9. Laboratory evidence of diabetes (urine dipstick chemistry)
10. Behavioural, cognitive or psychiatric disease that, in the opinion of the trial clinician, affects the ability of the participant to understand and comply with the study
11. Severe asthma (emergency room visit or hospitalisation)
12. Undergone splenectomy
13. Participation in other drug trials concurrent with this study
14. Any other condition that, in the opinion of the investigator (trial clinician), would risk the safety or rights of a participant in the trial or would render the subject unable to comply with the protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rates of nodules (onchocercomata) with normal embryogenesis assessed by histology 6 and 20 months after the start of drug administration.