Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mark Taylor

ORCID ID

Contact details

Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
+44 (0)151 7053112
mark.taylor@liv.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IC-A4-CT 2002-10051 WP2C

Study information

Scientific title

Acronym

WOLBACHFIL

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

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised double blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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 names

Doxycycline, Ivermectin

Primary outcome measures

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 measures

Macrofilaricidal (curative) effects of doxycycline treatment assessed by ultrasonography, histology and ribonucleic acid (RNA) levels of adult worms in onchocercomas at 21 months

Overall trial start date

01/07/2003

Overall trial end date

31/03/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Mean microfilaridermia >10 mf/mg
2. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180

Participant 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

Recruitment start date

01/07/2003

Recruitment end date

31/03/2005

Locations

Countries of recruitment

Cameroon

Trial participating centre

Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom

Sponsor information

Organisation

Liverpool School of Tropical Medicine (UK)

Sponsor details

Pembroke Place
Liverpool
L3 5QA
United Kingdom
+44 (0)151 7053281
hemingway@liv.ac.uk

Sponsor type

University/education

Website

http://www.liv.ac.uk/lstm

Funders

Funder type

Government

Funder name

European Commission (EC) (Contract IC-A4-CT 2002-10051)

Alternative name(s)

EC

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Belgium

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20405054

Publication citations

  1. Results

    Turner JD, Tendongfor N, Esum M, Johnston KL, Langley RS, Ford L, Faragher B, Specht S, Mand S, Hoerauf A, Enyong P, Wanji S, Taylor MJ, Macrofilaricidal activity after doxycycline only treatment of Onchocerca volvulus in an area of Loa loa co-endemicity: a randomized controlled trial., PLoS Negl Trop Dis, 2010, 4, 4, e660, doi: 10.1371/journal.pntd.0000660.

Editorial Notes