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
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