Condition category
Infections and Infestations
Date applied
02/06/2006
Date assigned
06/07/2006
Last edited
13/04/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Achim Hoerauf

ORCID ID

Contact details

Director of the Institute of Medical Microbiology Immunology and Parasitology (IMMIP)
University of Bonn
Faculty of Medicine
Sigmund Freud Str.25
Bonn
53105
Germany
+49 (0)228 287 5675
hoerauf@parasit.meb.uni-bonn.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EC contract IC-A4-CT 2002-10051 (WP 1)

Study information

Scientific title

Acronym

WOLBACHFIL

Study hypothesis

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

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)

Study design

Randomised, double-blind, placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Doxycycline, ivermectin

Primary outcome measures

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
2. Macrofilaricidal (curative) effects of doxycycline treatment as assessed by immunohistology, polymerase chain reaction (PCR) and ultrasonography at 5, 15 and 21 months

Secondary outcome measures

Reduction in adverse reaction to ivermectin treatment

Overall trial start date

01/08/2003

Overall trial end date

30/11/2005

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 (75 as of 13/04/07 - see interventions field)

Participant 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

Recruitment start date

01/08/2003

Recruitment end date

30/11/2005

Locations

Countries of recruitment

Ghana

Trial participating centre

Director of the Institute of Medical Microbiology Immunology and Parasitology (IMMIP)
Bonn
53105
Germany

Sponsor information

Organisation

European Commission (Belgium)

Sponsor details

European Commission
Research Directorate-General
Rue de la Loi 200
Bruxelles
B-1049
Belgium
+32 (0)2 299 1111
rtd-inco-projects@cec.eu.int

Sponsor type

Government

Website

http://www.europa.eu.int

Funders

Funder type

Government

Funder name

European Commission (EC) contract (Belgium) (ref: IC-A4-CT2002-10051)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes