Condition category
Infections and Infestations
Date applied
26/01/2009
Date assigned
05/03/2009
Last edited
05/03/2009
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

Director
MD
Institute of Medical Microbiology
Immunology and Parasitology
University of Bonn
Faculty of Medicine
Sigmund Freud Str. 25
Bonn
53105
Germany
+49 (0)228 287 15675
hoerauf@microbiology-bonn.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Targeting on the values of Wolbachia endosymbionts as novel feasible anti-filarial chemotherapeutic approach to prevent/reduce/clear disease in lymphatic filariasis and interrupt transmission in endemic communities of Tanzania: a randomised double-blind placebo-controlled trial

Acronym

Study hypothesis

Wolbachia endosymbionts bacteria are associated with inflammatory process in their human-host and filarial nematode causing overt clinical disease. However, the use of antibiotics with macrofilaricidal activity (doxycycline) that kills adult worms, might prevent or halt/cure/clear clinical disease such as lymphoedema (LE), acute dermatoadenolymphangitis (ADLA) or acute filarial fevers with lymphangitis (AFL). In the present study, it will be investigated whether patients with ongoing infection (i.e., who are positive for circulating filarial antigen [CFA]) will benefit more, in the same way or less than patients without ongoing infection (i.e. CFA negative) but remaining pathology.

Ethics approval

The Medical Research Coordinating Committee of Tanzania approved on 11th November 2005 (ref: NIMR/HQ/R.8a/vol.IX/403)

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Wuchereria bancrofti lymphoedema stage I - V

Intervention

45 individuals with circulating filarial antigen positive (CFA) and 45 individuals without circulating filarial antigen in their blood will be randomised to:
1. 200 mg/day doxycycline for 6 weeks
2. Placebo for 6 weeks

Contact details for co-investigator:
Dr WH Makunde
National Institute for Medical Research Tanga Centre
P.O. Box 5004
Tanga
Tanzania
Tel: +255 27 26 46084
Fax: +255 27 26 43869
E-mail hwmakunde@hotmail.com

Intervention type

Drug

Phase

Phase II

Drug names

Doxycycline

Primary outcome measures

1. Proportion of patients whose lymphoedema is reduced in size or cured
2. Proportion of acute filarial fevers and acute dermatoadenolymphangitis episodes or subclinical episodes prevented or reduced or halted during the trial period
3. Levels of CFA reduced or cleared
4. Levels of vascular endothelial growth factors (VEGFs) and pro-inflammatory immunological responses in plasma pre-post treatment in different stages of LE individuals

Secondary outcome measures

1. The length of time taken for LE to change in size or cured or reappear again
2. The levels of anti-Wolbachia surface protein antibodies response at pre-post treatment
3. Tolerability of the anti-Wolbachia agent (antibiotic-doxycycline) (drug adverse events)

Overall trial start date

27/09/2008

Overall trial end date

21/11/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age range 18 - 68 years
2. Males and females
3. Diagnosed clinically to have lymphoedema stages I - V
4. Permanent residents in the study area
5. May be microfilaraemia positive or negative

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90 individuals with lymphoedema

Participant exclusion criteria

1. Children and pregnant women
2. Chronic liver, kidney, cardiac, central nervous system disease
3. Allergy to the trial drugs
4. Previous history of using anti-filarial drugs, e.g. ivermectin, albendazole, diethylcarbamazine
5. Past history of taking anti-geohelminthics, e.g. mebendazole, and antibiotics such as tetracycline or rifampicin in the last six months

Recruitment start date

27/09/2008

Recruitment end date

21/11/2010

Locations

Countries of recruitment

Tanzania

Trial participating centre

Director, MD
Bonn
53105
Germany

Sponsor information

Organisation

Volkswagen Foundation (VolkswagenStiftung) (Germany)

Sponsor details

c/o Dr. Detlev Hanne
Division Natural and Engineering Sciences
Medicine
Kastanienallee 35
Hannover
30519
Germany
+49 (0)511 8381 0
info@volkswagenstiftung.de

Sponsor type

Research organisation

Website

http://www.volkswagenstiftung.de

Funders

Funder type

Research organisation

Funder name

Volkswagen Foundation (VolkswagenStiftung) (Germany)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Germany

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