Wolbachia endobacteria in filarial infections - exploring their usefulness as targets for novel chemotherapies that are anti-filarial and improve lymphoedema

Completed

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

• Registration Number: ISRCTN90861344
• Lead Sponsor: Volkswagen Foundation (VolkswagenStiftung) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Men and women aged between 18 - 60 years
2. Resident in the village for five years or more
3. Clinical stage of lymphoedema (1 - 5) of at least one extremity
4. Good general health without any clinical condition requiring long-term medication
5. Minimum body weight 40 kg

Exclusion Criteria

1. Pregnancy (if not obvious all women are tested by dipstick chemistry: beta-human chorionic gonadotrophin [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 or amoxicillin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of the stage of lymphoedema and number of acute attacks, measured pre-treatment as well as 3 months, 12 months and 24 months after the start of drug administration

Secondary Outcome Measures

Name	Time	Method
1. Reduction in circulating filarial antigen levels as a measure of a macrofilaricidal effect of doxycycline<br>2. Change in systemic immune responses<br><br>All measured pre-treatment as well as 3 months, 12 months and 24 months after the start of drug administration.