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