Condition category
Infections and Infestations
Date applied
10/02/2006
Date assigned
22/02/2006
Last edited
25/09/2009
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

Institute of Medical Microbiology
Immunology and Parasitology (IMMIP)
University of Bonn
Faculty of Medicine
Sigmund Freud str.26
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

Study information

Scientific title

Acronym

WOLBACHFIL

Study hypothesis

Wolbachia are symbiotic endobacteria in filarial nematodes that have recently emerged as targets for an 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 was:
1. To obtain the optimal regimen with anti-Wolbachia antibiotics leading to Wolbachia depletion and sterilization or killing of adult worms in human filariasis.
2. To analyze the role of Wolbachia in inflammatory processes which lead to disease manifestations (hydrocele, lymphedema, acute episodes of lymphangitis)
3. To investigate the role of Wolbachia release by microfilaricidal therapy in the induction of side effects. In their combination, the studies will allow us to assess the role of Wolbachia in the pathogenesis and as targets for the long-needed second punch for sustained interruption of transmission.

Ethics approval

Ethical clearance has been obtained from the Liverpool School of Tropical Medicine Research Ethics Committee on 06/12/2001, reference number 01.74 for the whole EC contract and from the Committee on Human Research Publications and Ethics, School of Medical Sciences, University of Science and Technology, Kumasi, Ghana on 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

Lymphatic filariasis due to infection with Wuchereria bancrofti

Intervention

Study drugs and treatment regimens:
1. 200 mg doxycycline per day orally for six weeks plus a single dose of ivermectin (150 µg/kg) plus albendazole (400 mg), four months after the start of doxycycline administration
2. Placebo matching doxycycline orally for six weeks plus a single dose of ivermectin (150 µg/kg)
plus albendazole (400 mg), four months after the start of doxycycline-placebo administration
3. 200 mg doxycycline per day orally for three weeks plus a single dose of ivermectin (150 µg/kg) plus albendazole (400 mg), four months after the start of doxycycline administration
4. Placebo matching doxycycline orally for three weeks plus a single dose of ivermectin (150 µg/kg) plus albendazole (400 mg), four months after the start of doxycycline-placebo administration

Intervention type

Drug

Phase

Not Specified

Drug names

1. Doxycycline
2. Ivermectin
3. Albendazole

Primary outcome measures

1. Depletion of Wolbachia (gene copies per Mf by quantitative Polymerase Chain Reaction [PCR])
2. Subsequent decline in microfilaraemia (according to Mf half-life) due to inferred sterility of adult worms
3. Macrofilaricidal effects, as assessed by ultrasonography and by reduction of circulating filarial antigen in serum
4. Decrease in size and grade of chronic pathology and frequency of acute inflammatory episodes

Secondary outcome measures

Reduction in adverse reaction to ivermectin treatment

Overall trial start date

01/12/2002

Overall trial end date

31/05/2005

Reason abandoned

Eligibility

Participant inclusion criteria

For all participants: subjects of both sexes, aged 18-50 years, who have given informed consent (written or thumb print) were evaluated. Minimum criteria was body weight >40 kg. Participants were only included in case they met the following criteria: normal renal and hepatic laboratory profiles for aspartate aminotransferase (AST) (0-40 IU/l), alanine aminotransferase (ALT) (0-45 IU/l), creatinine 53-126 µmol/l) as measured by dipstick chemistry.


For microfilaraemic participants: minimum criteria was microfilarial (Mf) counts >50 Mf/ml (finger pricks taken from night blood between 8 and 10 p.m., counted through a blood counting chamber, e.g. Sedgewick®.


For patients with early or chronic signs of disease: microfilaraemic or amicrofilaraemic, clinical manifestation of hydrocele and/or lymphedema.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

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

01/12/2002

Recruitment end date

31/05/2005

Locations

Countries of recruitment

Ghana

Trial participating centre

Institute of Medical Microbiology
Bonn
53105
Germany

Sponsor information

Organisation

European Commission

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

Other

Website

http://www.europa.eu.int

Funders

Funder type

Government

Funder name

European Commission

Alternative name(s)

EC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

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

Publication citations

Additional files

Editorial Notes