Condition category
Infections and Infestations
Date applied
19/01/2009
Date assigned
13/02/2009
Last edited
13/02/2009
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 Achim Hoerauf

ORCID ID

Contact details

Institute of Medical Microbiology
Immunology and Parasitology
University of Bonn
Faculty of Medicine
Sigmund Freud Str. 25
Bonn
53105
Germany
+49 (0)228 287 15675
hoerauf@microbiology-bonn.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1/81 306

Study information

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

Acronym

Study hypothesis

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

The Committee on Human Research Publication and Ethics, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana approved on 25th November 2005

Study design

Randomised double blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase II

Drug names

Doxycycline

Primary outcome measures

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 trial start date

01/12/2005

Overall trial end date

30/03/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

76

Participant 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

Recruitment start date

01/12/2005

Recruitment end date

30/03/2009

Locations

Countries of recruitment

Ghana

Trial participating centre

Institute of Medical Microbiology, Immunology and Parasitology
Bonn
53105
Germany

Sponsor information

Organisation

Volkswagen Foundation (VolkswagenStiftung) (Germany)

Sponsor details

c/o Dr Detlev Hanne
Division Natural and Engineering Sciences
Medicine
Kastanienallee 35
Hannover
30519
Germany
+49 (0)511 8381 0
info@volkswagenstiftung.de

Sponsor type

Research organisation

Website

http://www.volkswagenstiftung.de

Funders

Funder type

Research organisation

Funder name

Volkswagen Foundation (VolkswagenStiftung) (Germany) (ref: 1/81 306)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Germany

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

Publication citations

Additional files

Editorial Notes