Condition category
Infections and Infestations
Date applied
31/05/2010
Date assigned
08/07/2010
Last edited
08/07/2010
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 Clinic Bonn
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

1/81306 extension

Study information

Scientific title

Anti-wolbachial therapy with doxycycline to ameliorate filaricele pathology: a randomised, double-blind, placebo-controlled trial

Acronym

Study hypothesis

1. To assess the possibility of using the combination of doxycycline treatment and ultrasound-guided aspiration of hydrocele fluid to replace or supplement the current hydrocelectomy strategy.
2. To explore the possibility to differentiate between hydrocele and chylocele by ultrasonography (USG).

Ethics approval

Ethical clearances have been obtained from the Committee on Human Research Publication and Ethics, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana (approved April 29th, 2010) and from the Ethical Committee, University Clinic Bonn, Faculty of Medicine, Bonn, Germany (approved March 8th, 2010).

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

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

Condition

Lymphatic filariasis (Wuchereria bancrofti)

Intervention

The participants will be randomised and assigned to one of two treatment regimens:
1. 6 weeks doxycycline (2 x 100 mg/day) (n = 33)
2. 6 weeks placebo matching doxycycline (2 capsules/day) (n = 33)

Volunteers for this study are recruited based on the inclusion and exclusion criteria and treated directly in their villages (Ahanta West district, Ghana). The study-drugs will be distributed ad personam by the research staff and drug intake monitored on a daily basis for 6 weeks.
All participants will undergo ultrasound-guided aspiration 4 months after treatment onset. Two experienced MD’s (urologist and ultrasonographer) will perform the aspiration together under aseptic conditions in a hospital. To avoid traumata during aspiration (lesions of the testis or intra-scrotal vessels) a disposable needle guide will be affixed to the ultrasound transducer by a clamp. This device will help the urologist to aid in positioning the needle to impede that the needle/drainage tube gets too close to the testis and scrotal vessels and therefore prevents unwanted bleeding or lesions of the tunica vaginalis parietalis and visceralis and the testis. Skin disinfectant and sterile ultrasound gel will be used to prevent infection due to exogenous bacteria. The total amount of fluid surrounding the testis will be obtained. 24 hours after aspiration participants will be visited and scanned again for safety reasons to make sure that no bleeding or infection occurred. In case of any aspiration related problem, the responsible urologist and MD will care for the patient until resolution. The patient will receive appropriate treatment, i.e. analgesic drugs, antibiotics, if necessary.
The total duration of follow-up for both arms of our trial is 12 months after the start of drug administration.

Contact details for Joint Principal Investigators:
Prof Dr Ohene Adjei
Chief Executive Officer
Komfo Anokye Teaching Hospital (KATH)
Kwame Nkrumah University of Science and Technology (KNUST)
Kumasi, Ghana
Tel: + 233 51 60351
Fax: + 233 51 62017
E-mail: oadjei@africaonline.com, oadjei@kathhsp.org

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

Other

Phase

Phase IV

Drug names

Primary outcome measures

Improvement of filaricele size (stage) between study onset (pre-treatment) and 8 months after aspiration (12 months after study onset). Improvement is defined as pre-treatment stage of hydrocele minus one stage (minimum) 8 months after aspiration. Hydrocele stage is determined according to Debrah et al.,2007.

Secondary outcome measures

1. Improvement of filaricele size (stage) between study onset (pre-treatment) and pre-aspiration (time point 4 months after doxycycline/placebo treatment) as well as 3 months after aspiration (7 months after study onset)
2. Improvement of filaricele size (stage) between pre-aspiration (4 months after study onset) and 3 and 8 months after aspiration (7 and 12 months after study onset)
3. Curative effect of the combined drug and aspiration treatment, measured at 3 and 8 months after aspiration (i.e. 7 and 12 months after drug treatment onset). A curative effect is defined as no fluid accumulation (no relapse after aspiration)
4. Reduction of supra-testicular lymphatic vessel dilation between pre-treatment and pre-aspiration as well as 3 and 8 months after aspiration (7 and 12 months after start of treatment)
5. Proof or rejection that improvement of hydrocele stage correlates with increase of immunosuppressive markers e.g. TGF, IL-10, lower levels of inflammatory cytokines e.g. IL-4, IL-6, IL-12, IL-17, INFγ, TNF and decrease of angiogenic parameters, e.g. VEGFs, measured in blood samples pre-treatment, pre-aspiration as well as 3 and 8 months after aspiration (7 and 12 months after start of treatment)
6. Proof or rejection that improvement of hydrocele stage correlates with increase of immunosuppressive markers e.g. TGF, IL-10, lower levels of inflammatory cytokines e.g. IL-4, IL-6, IL-12, IL-17, INFγ, TNF and decrease of angiogenic parameters, e.g. VEGFs, measured in hydrocele fluid obtained during aspiration. Clinical findings at 3 and 8 months after aspiration will be assessed and correlated with results of the aspirated fluid
7. Proof or rejection that USG is able to differentiate chylocele (EDH) from hydrocele (EFH) based on correlation of biochemical markers such as chylomicrons, lipoproteins, cytokines, with ultrasonographical findings

Overall trial start date

01/05/2010

Overall trial end date

31/05/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men between 18-55 years old
2. Good general health, without any clinical condition requiring long-term medication and with normal renal and hepatic laboratory profiles
3. Body weight > 40 kg
4. Presence of hydrocele stage 2 or 3, detected by ultrasound (as described in Debrah et al., 2007)
5. Willingness to participate in the study as evidenced by signing of the informed consent document (written or thumb print)
6. Resident in the endemic area for 5 years or more

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

66

Participant exclusion criteria

1. Known intolerance to the study drug doxycycline
2. History of a severe allergic reaction or anaphylaxis
3. History of alcohol or drug abuse
4. Evidence of clinically significant neurological, cardiac, pulmonary, hepatic, rheumatologic, metabolic or renal disease as far as it can be assessed by history of participants, physical examination, and/or laboratory examinations including blood and urine analyses
5. Laboratory evidence of liver disease (alanine aminotransferase [ALT], gamma-glutamyl transferase [gamma-GT] greater than 1.25 times the upper limit of normal results given by the dipstick test manufacturer, Roche)
6. Laboratory evidence of renal disease (serum creatinine greater than 1.25 times the upper limit of normal results given by the dipstick test manufacturer, Roche)
7. Laboratory evidence of diabetes (urine dipstick chemistry)
8.Behavioural, cognitive, or psychiatric disease that, in the opinion of the trial clinician, affects the ability of the participant to understand and comply with the study
9. Severe asthma or respiratory disease (evidenced by a past emergency room visit or hospitalization)
10. Participation in other drug trials concurrent with this study
11. Any other condition that, in the opinion of the investigator (trial clinician), would risk the safety or rights of a participant in the trial or would render the subject unable to comply with the protocol

Recruitment start date

01/05/2010

Recruitment end date

31/05/2012

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 of Natural and Engineering Sciences
Medicine
Kastanienallee 35
Hannover
30519
Germany
+49 (0)511 8381 0
info@volkswagenstiftung.de

Sponsor type

Charity

Website

http://www.volkswagenstiftung.de

Funders

Funder type

Charity

Funder name

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

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