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 |
| Secondary identifying numbers | EU contract 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
Scientific
Department of Parasitology
Leiden University Medical Center
Albinusdreef 2
Leiden
2333 ZA
Netherlands
Study information
| Study design | Randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/03/2003 |
| Completion date | 01/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 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
2333 ZA
Netherlands
Sponsor information
European Commission (Belgium)
Government
Government
European Commission
Research Directorate-General
Rue de la Loi 200
Bruxelles
B-1049
Belgium
| Phone | +32 (0)2 299 1111 |
|---|---|
| rtd-inco-projects@cec.eu.int | |
| Website | http://www/europa.eu.int |
"ROR" |
https://ror.org/00k4n6c32 |
Funders
Funder type
Government
European Commission (EC) contract (reference number: ICA4-CT-2002-10051)
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2008 | Yes | No |
