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Anti-wolbachia treatment of onchocerciasis in an area co-endemic for loiasis
ISRCTN ISRCTN48118452
DOI 10.1186/ISRCTN48118452
ClinicalTrials.gov identifier
EudraCT number
Public title Anti-wolbachia treatment of onchocerciasis in an area co-endemic for loiasis
Scientific title
Acronym WOLBACHFIL
Serial number at source IC-A4-CT 2002-10051 WP2C
Study hypothesis 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
Lay summary
Ethics approval Ethics approval received from the local medical ethics committee
Study design Randomised double blind placebo controlled trial
Countries of recruitment Cameroon
Disease/condition/study domain Onchocerciasis, loiasis
Participants - inclusion criteria 1. Mean microfilaridermia >10 mf/mg
2. Informed consent
Participants - 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
Anticipated start date 01/07/2003
Anticipated end date 31/03/2005
Status of trial Completed
Patient information material
Target number of participants 180
Interventions 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
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
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
Sources of funding European Commission (EC) (Contract IC-A4-CT 2002-10051)
Trial website
Publications 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20405054
Contact name Dr  Mark  Taylor
  Address Liverpool School of Tropical Medicine
Pembroke Place
  City/town Liverpool
  Zip/Postcode L3 5QA
  Country United Kingdom
  Tel +44 (0)151 7053112
  Fax +44 (0)151 7053371
  Email mark.taylor@liv.ac.uk
Sponsor Liverpool School of Tropical Medicine (UK)
  Address Pembroke Place
  City/town Liverpool
  Zip/Postcode L3 5QA
  Country United Kingdom
  Tel +44 (0)151 7053281
  Fax +44 (0)151 7053371
  Email hemingway@liv.ac.uk
  Sponsor website: http://www.liv.ac.uk/lstm
Date applied 12/01/2006
Last edited 21/04/2010
Date ISRCTN assigned 24/01/2006
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