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 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 trial start date
01/12/2005
Overall trial end date
30/03/2009
Reason abandoned (if study stopped)
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
Funders
Funder type
Research organisation
Funder name
Volkswagen Foundation (VolkswagenStiftung) (Germany) (ref: 1/81 306)
Alternative name(s)
VolkswagenStiftung
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
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
Basic results (scientific)
Publication list