Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Achim Hoerauf


Contact details

Institute of Medical Microbiology
Immunology and Parasitology
University of Bonn
Faculty of Medicine
Sigmund Freud Str. 25
+49 (0)228 287 15675

Additional identifiers

EudraCT number 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 lymphoedema: a randomised double blind placebo-controlled trial


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 lymphoedema.

The aim of this project is:
1. To analyse to what extent lymphoedema is caused by Wolbachia. To this, the Wolbachia-depleting antibiotic doxycycline will be compared with amoxicillin, which does not target Wolbachia but only opportunistic exogenous bacteria that may worsen lymphoedema.
2. To analyse the role of Wolbachia in the systemic immune responses in lymphoedema 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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Lymphatic filariasis (Wuchereria bancrofti)


Study drugs and treatment regimens:
1. 200 mg/day doxycycline for 6 weeks
2. 1000 mg/day amoxicillin for 6 weeks
3. 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

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

Intervention type



Phase II

Drug names

Doxycycline, amoxicillin

Primary outcome measure

Reduction of the stage of lymphoedema and number of acute attacks, measured pre-treatment as well as 3 months, 12 months and 24 months after the start of drug administration

Secondary outcome measures

1. Reduction in circulating filarial antigen levels as a measure of a macrofilaricidal effect of doxycycline
2. Change in systemic immune responses

All measured pre-treatment as well as 3 months, 12 months and 24 months after the start of drug administration.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Men and women aged between 18 - 60 years
2. Resident in the village for five years or more
3. Clinical stage of lymphoedema (1 - 5) of at least one extremity
4. Good general health without any clinical condition requiring long-term medication
5. Minimum body weight 40 kg

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Pregnancy (if not obvious all women are tested by dipstick chemistry: beta-human chorionic gonadotrophin [BhCG])
2. Currently breast-feeding
3. Evidence of clinically significant neurological, cardiac, pulmonary, hepatic, rheumatological, or renal disease by history, physical examination, and/or laboratory tests
4. 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
5. 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)
6. Laboratory evidence of renal disease (serum creatinine greater than 1.25 times the upper limit of normal of the testing laboratory)
7. Other condition 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
8. Volunteer has abused alcohol or illicit drugs during the past 6 months by history
9. History of severe allergic reaction or anaphylaxis
10. Intolerance to doxycycline or amoxicillin

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Institute of Medical Microbiology, Immunology and Parasitology

Sponsor information


Volkswagen Foundation (VolkswagenStiftung) (Germany)

Sponsor details

c/o Dr. Detlev Hanne
Division Natural and Engineering Sciences
Kastanienallee 35
+49 (0)511 8381 0

Sponsor type

Research organisation



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

Trusts, charities, foundations (both public and private)



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

1. 2012 results in

Publication citations

  1. Results

    Mand S, Debrah AY, Klarmann U, Batsa L, Marfo-Debrekyei Y, Kwarteng A, Specht S, Belda-Domene A, Fimmers R, Taylor M, Adjei O, Hoerauf A, Doxycycline improves filarial lymphedema independent of active filarial infection: a randomized controlled trial., Clin. Infect. Dis., 2012, 55, 5, 621-630, doi: 10.1093/cid/cis486.

Additional files

Editorial Notes