Wolbachia endobacteria in filarial infections - exploring their usefulness as targets for novel chemotherapies that are anti-filarial and improve hydrocele
| ISRCTN | ISRCTN19748404 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19748404 |
| Secondary identifying numbers | 1/81 306 |
- Submission date
- 19/01/2009
- Registration date
- 13/02/2009
- Last edited
- 13/02/2009
- 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
Scientific
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 |
|---|---|
| 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 | Wolbachia endobacteria in filarial infections - exploring their usefulness as targets for novel chemotherapies that are anti-filarial and improve hydrocele: a randomised double blind placebo-controlled trial |
| Study objectives | Filarial infections belong to the major diseases in sub-Saharan Africa and are strongly associated with poverty. At present, World Health Organization (WHO) led control activities in Africa mainly rely on mass administration of microfilaricidal drugs, with a measure of success. However, it has become clear that new, complementary therapies, ideally being macrofilaricidal, must be developed for sustainable control. In lymphatic filariasis (LF), there is the additional need to deliver new therapies for lymphatic pathology, i.e. lymphoedema and urogenital pathology such as hydrocele and lymphocele, which are not targeted by current mass drug administrations. Depletion of Wolbachia essential endosymbionts of filariae with doxycycline, an approach established by our group, resulted in macrofilaricidal activity in LF. The present study hypothesises that Wolbachia also play a major role in inducing and maintaining lymphatic pathology, and that doxycycline may therefore improve hydrocele. The aim of this project is: 1. To analyse to what extent hydrocele is caused by Wolbachia. To this, the Wolbachia-depleting antibiotic doxycycline will be administered and alterations of hydrocele size will be determined. 2. To analyse the role of Wolbachia in the systemic immune responses in hydrocele patients, by comparing immune responses before and after Wolbachia depletion |
| Ethics approval(s) | The Committee on Human Research Publication and Ethics, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana approved on 25th November 2005 |
| Health condition(s) or problem(s) studied | Lymphatic filariasis (Wuchereria bancrofti) |
| Intervention | Study drugs and treatment regimens: 1. 200 mg/day doxycycline for 6 weeks 2. Placebo for 6 weeks Contact details for Joint Principal Investigators: Professor Ohene Adjei Kwame Nkrumah University of Science and Technology (KNUST), and Kumasi Centre of Collaborative Research (KCCR) University Post Office Kumasi, Ghana Tel: + 233 51 60351 Fax: + 233 51 62017 E-mail: oadjei@africaonline.com Dr Alexander Yaw Debrah Kwame Nkrumah University of Science and Technology (KNUST), and Kumasi Centre of Collaborative Research (KCCR) University Post Office Kumasi, Ghana Tel: + 233 51 60351 Fax: + 233 51 62017 E-mail: yadebrah@yahoo.com |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Doxycycline |
| Primary outcome measure | Reduction in size of clinical and sub-clinical hydrocele, measured pre-treatment as well as 12 months and 24 months after the start of drug administration. |
| Secondary outcome measures | 1. Reduction in the stage of supratesticular dilation of scrotal lymphatic vessels, measured pre-treatment as well as 12 months and 24 months after the start of drug administration 2. Reduction in circulating filarial antigen levels as a measure of macrofilaricidal effect of doxycycline, measured pre-treatment as well as 3 months, 12 months and 24 months after the start of drug administration 3. Change in systemic immune responses, measured pre-treatment as well as 3 months, 12 months and 24 months after the start of drug administration |
| Overall study start date | 01/12/2005 |
| Completion date | 30/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 76 |
| Key inclusion criteria | 1. Men between 18 - 60 years 2. Resident in the village for five years or more 3. Evidence of hydrocele assessed by physical examination and ultrasonography 4. Good general health without any clinical condition requiring long-term medication 5. Minimum body weight 40 kg |
| Key exclusion criteria | 1. Evidence of clinically significant neurological, cardiac, pulmonary, hepatic, rheumatological, or renal disease by history, physical examination, and/or laboratory tests 2. Behavioural, cognitive or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study protocol 3. Laboratory evidence of liver disease (aspartate aminotransferase [AST] alanine aminotransferase [ALT] and/or gamma-glutamyl transferase (gGT) greater than 1.25 times the upper limit of normal of the testing laboratory) 4. Laboratory evidence of renal disease (serum creatinine greater than 1.25 times of the upper limit of normal of the testing laboratory) 5. Other conditions that, in the opinion of the investigator, would jeopardise the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol 6. Volunteer has abused alcohol or illicit drugs during the past 6 months by history 7. History of severe allergic reaction or anaphylaxis 8. Intolerance to doxycycline |
| Date of first enrolment | 01/12/2005 |
| Date of final enrolment | 30/03/2009 |
Locations
Countries of recruitment
- Germany
- Ghana
Study participating centre
Institute of Medical Microbiology, Immunology and Parasitology
Bonn
53105
Germany
53105
Germany
Sponsor information
Volkswagen Foundation (VolkswagenStiftung) (Germany)
Research organisation
Research organisation
c/o Dr Detlev Hanne
Division Natural and Engineering Sciences, Medicine
Kastanienallee 35
Hannover
30519
Germany
| Phone | +49 (0)511 8381 0 |
|---|---|
| info@volkswagenstiftung.de | |
| Website | http://www.volkswagenstiftung.de |
"ROR" |
https://ror.org/03bsmfz84 |
Funders
Funder type
Research organisation
Volkswagen Foundation (VolkswagenStiftung) (Germany) (ref: 1/81 306)
Private sector organisation / Trusts, charities, foundations (both public and private)
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 |
