Antibiotic targeting of Wolbachia endosymbiotic bacteria as a new approach to the treatment of filarial (Wuchereria bancrofti) infection and disease

Completed

Conditions: ymphatic filariasis due to infection with Wuchereria bancrofti
Infections and Infestations

Registration Number: ISRCTN56578422

Lead Sponsor: European Commission

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 240

Inclusion Criteria

For all participants: subjects of both sexes, aged 18-50 years, who have given informed consent (written or thumb print) were evaluated. Minimum criteria was body weight >40 kg. Participants were only included in case they met the following criteria: normal renal and hepatic laboratory profiles for aspartate aminotransferase (AST) (0-40 IU/l), alanine aminotransferase (ALT) (0-45 IU/l), creatinine 53-126 µmol/l) as measured by dipstick chemistry.

For microfilaraemic participants: minimum criteria was microfilarial (Mf) counts >50 Mf/ml (finger pricks taken from night blood between 8 and 10 p.m., counted through a blood counting chamber, e.g. Sedgewick®.

For patients with early or chronic signs of disease: microfilaraemic or amicrofilaraemic, clinical manifestation of hydrocele and/or lymphedema.

Exclusion Criteria

1. Pregnancy (pregnancy test)
2. Lactation
3. Intolerance to ivermectin or doxycycline
4. Chronic diseases
5. Alcohol or drug abuse
6. Anti-filarial therapy within the last two years

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Depletion of Wolbachia (gene copies per Mf by quantitative Polymerase Chain Reaction [PCR])<br>2. Subsequent decline in microfilaraemia (according to Mf half-life) due to inferred sterility of adult worms<br>3. Macrofilaricidal effects, as assessed by ultrasonography and by reduction of circulating filarial antigen in serum<br>4. Decrease in size and grade of chronic pathology and frequency of acute inflammatory episodes

Secondary Outcome Measures