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

ISRCTN	ISRCTN12273637
DOI	https://doi.org/10.1186/ISRCTN12273637
Secondary identifying numbers	N/A

Submission date: 26/01/2009
Registration date: 05/03/2009
Last edited: 05/03/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Achim Hoerauf
Scientific

Director, MD
Institute of Medical Microbiology, Immunology and Parasitology
University of Bonn, Faculty of Medicine
Sigmund Freud Str. 25
Bonn
53105
Germany

Phone	+49 (0)228 287 15675
Email	hoerauf@microbiology-bonn.de

Study information

Study design	Randomised double-blind placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	The Medical Research Coordinating Committee of Tanzania approved on 11th November 2005 (ref: NIMR/HQ/R.8a/vol.IX/403)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Doxycycline
Primary outcome measure	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 study start date	27/09/2008
Completion date	21/11/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	90 individuals with lymphoedema
Key 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
Key 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
Date of first enrolment	27/09/2008
Date of final enrolment	21/11/2010

Locations

Countries of recruitment

Germany
Tanzania

Study participating centre

Director, MD

Bonn
53105
Germany

Sponsor information

Volkswagen Foundation (VolkswagenStiftung) (Germany)
Research organisation

c/o Dr. Detlev Hanne
Division Natural and Engineering Sciences, Medicine
Kastanienallee 35
Hannover
30519
Germany

Phone	+49 (0)511 8381 0
Email	info@volkswagenstiftung.de
Website	http://www.volkswagenstiftung.de
"ROR"	https://ror.org/03bsmfz84

Funders

Funder type

Research organisation

Volkswagen Foundation (VolkswagenStiftung) (Germany)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): VolkswagenStiftung
Location: Germany

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan