Anti-wolbachia treatment of onchocerciasis in an area co-endemic for loiasis
| ISRCTN | ISRCTN48118452 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48118452 |
| Protocol serial number | IC-A4-CT 2002-10051 WP2C |
| Sponsor | Liverpool School of Tropical Medicine (UK) |
| Funder | European Commission (EC) (Contract IC-A4-CT 2002-10051) |
- Submission date
- 12/01/2006
- Registration date
- 24/01/2006
- Last edited
- 21/04/2010
- 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
Dr Mark Taylor
Scientific
Scientific
Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
| Phone | +44 (0)151 7053112 |
|---|---|
| mark.taylor@liv.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | WOLBACHFIL |
| Study objectives | Anti-wolbachia (doxycycline) treatment or anti-wolbachia treatment combined with standard anti-filarial treatment (ivermectin) has superior efficacy compared with standard anti-filarial treatment of onchocerciasis. Doxycycline is a suitable and efficacious treatment for onchocerciasis in patients co-infected with loiasis |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Onchocerciasis, loiasis |
| Intervention | 200 mg/day oral doxycycline or matching placebo for six weeks 150 mg/kg oral single dose ivermectin or matching placebo for four months post commencement of doxycycline treatment |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Doxycycline, Ivermectin |
| Primary outcome measure(s) |
Sustained amicrofilaridermia in doxycycline or doxycycline and ivermectin-treated patients compared with ivermectin treated-patients assessed by levels of microfilaridermia in skin biopsies at 4, 12 and 21 months |
| Key secondary outcome measure(s) |
Macrofilaricidal (curative) effects of doxycycline treatment assessed by ultrasonography, histology and ribonucleic acid (RNA) levels of adult worms in onchocercomas at 21 months |
| Completion date | 31/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 180 |
| Key inclusion criteria | 1. Mean microfilaridermia >10 mf/mg 2. Informed consent |
| Key exclusion criteria | 1. Body weight <40 kg 2. Ages <15 or >50 3. Patients receiving medication for chronic illness 4. Anti-filarial treatment in the last year 5. Alcohol or drug abuse 6. Abnormal renal or hepatic blood chemistry 7. Pregnancy 8. Lactation |
| Date of first enrolment | 01/07/2003 |
| Date of final enrolment | 31/03/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
- Cameroon
Study participating centre
Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom
L3 5QA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/04/2010 | Yes | No |
