Antibiotic targeting of wolbachia endosymbiotic bacteria as a new approach to the treatment of filarial (Onchocerca Volvulus) infection and disease
| ISRCTN | ISRCTN71141922 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71141922 |
| Protocol serial number | EC contract IC-A4-CT 2002-10051 (WP 1) |
| Sponsor | European Commission (Belgium) |
| Funder | European Commission (EC) contract (Belgium) (ref: IC-A4-CT2002-10051) |
- Submission date
- 02/06/2006
- Registration date
- 06/07/2006
- Last edited
- 09/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Achim Hoerauf
Scientific
Scientific
Director of the Institute of Medical Microbiology Immunology and Parasitology (IMMIP)
University of Bonn
Faculty of Medicine
Sigmund Freud Str.25
Bonn
53105
Germany
| Phone | +49 (0)228 287 5675 |
|---|---|
| hoerauf@parasit.meb.uni-bonn.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double-blind, placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Antibiotic targeting of wolbachia endosymbiotic bacteria as a new approach to the treatment of filarial (Onchocerca Volvulus) infection and disease |
| Study acronym | WOLBACHFIL |
| Study objectives | Wolbachia are symbiotic endobacteria in filarial nematodes that have recently emerged as targets for improved chemotherapy of filariasis by tetracycline antibiotics, with the potential to close the gap left open in current mass treatment programs. The purpose of this project is: 1. To define the minimum regimen of anti-wolbachia drug doxycycline needed to achieve depletion of wolbachia and a complete sterilization of adult female worms in onchocerciasis, as well as sustained amicrofilaraemia in combination with ivermectin 2. To verify or reject the macrofilaricidal effect of doxycycline 3. To investigate the role of wolbachia-release by microfilaricidal therapy in the induction of side effects. The study will allow us to assess the role of wolbachia in pathogenesis and as targets for the long-needed second punch for sustained amicrofilaraemia and interruption of transmission. |
| Ethics approval(s) | Ethical approval has been obtained from the Liverpool School of Tropical Medicine Research Ethics Committee dated 06/12/2001, reference number: 01.74 for the whole EC contract and also from the Committee on Human Research Publications and Ethics, School of Medical Sciences, University of Science and Technology, Kumasi, Ghana dated 20/01/2003) |
| Health condition(s) or problem(s) studied | Onchocerciasis (river blindness) |
| Intervention | 200 mg/day Oral doxycycline or matching placebo for six weeks versus four weeks; 150 mg/kg oral single dose ivermectin or matching placebo four months post-commencement of doxycycline treatment. Added as of 13/04/2007: 200 was an erroneous copy-paste from an older version of the study protocol which got down-scaled by the Ethics Committee during the process of ethical clearance - the final study protocol version contained three treatment arms with 25 participants each, therefore a total number of 75 participants. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Doxycycline, ivermectin |
| Primary outcome measure(s) |
1. Sustained amicrofilaraemia in doxycycline- and ivermectin-treated patients compared with ivermectin-treated patients as assessed by levels of microfilaridermia in skin biopsies at 5,15 and 21 months |
| Key secondary outcome measure(s) |
Reduction in adverse reaction to ivermectin treatment |
| Completion date | 30/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Total final enrolment | 67 |
| Key inclusion criteria | All male or female subjects, aged 18-50 years, who have given informed consent (written or thumb print) were evaluated. Minimum body weight criteria is >40 kg. Participants were then included only if they met the following criteria: 1. Normal renal and hepatic laboratory profiles for aspartate aminotransferase (AST) (0-40 IU/l), alanine aminotransferase (ALT) (0-45 IU/l) 2. Creatinine 53-126 µmol/l as measured by dipstick chemistry 3. More than two palpable onchocercomas 4. Microfilarial (Mf) counts >10 Mf/mg (skin biopsies) |
| Key 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 |
| Date of first enrolment | 01/08/2003 |
| Date of final enrolment | 30/11/2005 |
Locations
Countries of recruitment
- Germany
- Ghana
Study participating centre
Director of the Institute of Medical Microbiology Immunology and Parasitology (IMMIP)
Bonn
53105
Germany
53105
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2008 | 09/05/2019 | Yes | No |
Editorial Notes
09/05/2019: Publication reference and total final enrolment added.
