Comparison of doxycycline alone versus doxycycline plus rifampicin in their efficacy against lymphatic filariasis

Completed

• Conditions: ymphatic filariasis (Wuchereria bancrofti); Infections and Infestations; Filariasis

• Registration Number: ISRCTN15216778
• Lead Sponsor: iverpool School of Tropical Medicine (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 299

Inclusion Criteria

Current inclusion criteria as of 08/11/2012 (protocol change approved by the DMEC of this trial on 02/03/2011):
1. Men aged between 18 - 50 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): =40kg
4. Presence of at least one scrotal worm nest detected by ultrasonography

Previous inclusion criteria until 08/11/2012:
3. Body weight (BW): 40 - 70 kg

Exclusion Criteria

1. Known intolerance to the study drugs (doxycycline, rifampicin), or to ivermectin and/or albendazole
2. History of severe allergic reaction or anaphylaxis
3. History of alcohol or drug abuse
4. Anti-filarial therapy within the last 10 months
5. Evidence of clinically significant neurological, cardiac, pulmonary, hepatic, metabolic, rheumatologic or renal disease as far as it can be assessed by history of participants, physical examination, and/or laboratory examinations including blood and urine analysis
6. Laboratory evidence of liver disease (alanine aminotransferase [ALT], gamma-glutamyl transferase [gamma-GT] greater than 1.25 times the upper limit of normal results as stated by the manufacturer of dipstick tests, Roche®)
7. 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®)
8. Laboratory evidence of diabetes (urine dipstick chemistry)
9. 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
10. Severe asthma or respiratory disease (emergency room visit or hospitalisation)
11. Undergone splenectomy
12. Participation in other drug trials concurrent with this study
13. 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