Antibiotic targeting of Wolbachia endosymbiotic bacteria as a new approach to the treatment of filarial (Brugia malayi) infection and disease

ISRCTN	ISRCTN37962059
DOI	https://doi.org/10.1186/ISRCTN37962059
Protocol serial number	EU contract ICA4-CT-2002-10051
Sponsor	European Commission (Belgium)
Funder	European Commission (EC) contract (reference number: ICA4-CT-2002-10051)

Submission date: 21/09/2006
Registration date: 31/10/2006
Last edited: 25/09/2009

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Maria Yazdanbakhsh
Scientific

Department of Parasitology
Leiden University Medical Center
Albinusdreef 2
Leiden
2333 ZA
Netherlands

Study information

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	WOLBACHFIL
Study objectives	Filarial infection and disease is associated with episodes of acute and chronic inflammation that can lead to lymphangitis, hydrocele and elephantiasis. Wolbachia are symbiotic endobacteria in filarial nematodes that have recently emerged as targets for improved chemotherapy of filariasis by tetracycline antibiotics, with potential to close the gap left open in current mass treatment programs. The purpose of this project is: 1. To define if anti-Wolbachia treatment is effective to deplete Wolbachia from Brugia malayi, and, that in combination with Diethylcarbamazine (DEC), leads to a sustained amicrofilaraemia in brugian filariasis 2. To determine if anti-Wolbachia treatment leads to reduced adverse reactions to filarial chemotherapy
Ethics approval(s)	Ethical clearance has been obtained from Liverpool School of Tropical Medicine Research Ethics Committee dated 06/12/2001 (reference number: 01.74) for whole EU contract and also from the Committee of the Medical Ethics of the Faculty of Medicine, University of Indonesia, Jakarta, Indonesia, dated 12/08/2002 (reference number: 65/ PT01.FK/Etik/2002).
Health condition(s) or problem(s) studied	Filarial infection and disease from Brugia malayi
Intervention	100 mg/kg doxycycline or matching placebo for six weeks, 6 mg/kg oral DEC plus 400 mg Albendazole or matching placebo for four months post-commencement of doxycycline treatment.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Doxycycline, diethylcarbamazine and albendazole
Primary outcome measure(s)	Sustained amicrofilaraemia in doxycycline or doxycycline and DEC and Albendazole treated patients compared with DEC and Albendazole treated patients as assessed by levels of microfilariae in night blood at two, four and 12 months.
Key secondary outcome measure(s)	Reduction in adverse reaction to DEC and Albendazole treatment.
Completion date	01/09/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	150
Key inclusion criteria	1. All male and female subjects, who have given informed consent were evaluated 2. Mean microfilariae more than 5 Mf/ml
Key exclusion criteria	1. Aged less than 12 years 2. Patients receiving medication for chronic illness 3. Anti-filarial treatment in the last year 4. Alcohol or drug abuse 5. Pregnancy 6. Lactation 7. Abnormal renal or hepatic blood chemistry
Date of first enrolment	01/03/2003
Date of final enrolment	01/09/2004

Locations

Countries of recruitment

Indonesia
Netherlands

Study participating centre

Department of Parasitology

Leiden
2333 ZA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2008		Yes	No