Condition category
Infections and Infestations
Date applied
21/09/2006
Date assigned
31/10/2006
Last edited
25/09/2009
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 Maria Yazdanbakhsh

ORCID ID

Contact details

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

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 measures

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

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

http://www/europa.eu.int

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18419441

Publication citations

  1. 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.

Additional files

Editorial Notes