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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN56578422
Enrollment
240
Registered
2006-02-22
Start date
2002-12-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphatic filariasis due to infection with Wuchereria bancrofti Infections and Infestations

Interventions

Study drugs and treatment regimens: 1. 200 mg doxycycline per day orally for six weeks plus a single dose of ivermectin (150 µg/kg) plus albendazole (400 mg), four months after the start of doxycycli

Sponsors

European Commission
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Reduction in adverse reaction to ivermectin treatment

Countries

Ghana

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026