Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EU contract ICA4-CT-2002-10051
Study information
Scientific title
Acronym
WOLBACHFIL
Study hypothesis
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
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).
Study design
Randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Doxycycline, diethylcarbamazine and albendazole
Primary outcome measure
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.
Secondary outcome measures
Reduction in adverse reaction to DEC and Albendazole treatment.
Overall trial start date
01/03/2003
Overall trial end date
01/09/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All male and female subjects, who have given informed consent were evaluated
2. Mean microfilariae more than 5 Mf/ml
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
150
Participant 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
Recruitment start date
01/03/2003
Recruitment end date
01/09/2004
Locations
Countries of recruitment
Indonesia
Trial participating centre
Department of Parasitology
Leiden
2333 ZA
Netherlands
Sponsor information
Organisation
European Commission (Belgium)
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
Government
Website
Funders
Funder type
Government
Funder name
European Commission (EC) contract (reference number: ICA4-CT-2002-10051)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18419441
Publication citations
-
Results
Supali T, Djuardi Y, Pfarr KM, Wibowo H, Taylor MJ, Hoerauf A, Houwing-Duistermaat JJ, Yazdanbakhsh M, Sartono E, Doxycycline treatment of Brugia malayi-infected persons reduces microfilaremia and adverse reactions after diethylcarbamazine and albendazole treatment., Clin. Infect. Dis., 2008, 46, 9, 1385-1393, doi: 10.1086/586753.