Doxycycline treatment to eliminate Onchocerca volvulus worms that respond poorly to ivermectin

ISRCTN	ISRCTN66649839
DOI	https://doi.org/10.1186/ISRCTN66649839
Secondary identifying numbers	INCO-CT-2006-032321

Submission date: 19/01/2009
Registration date: 13/02/2009
Last edited: 30/07/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Achim Hoerauf
Scientific

Institute of Medical Microbiology, Immunology and Parasitology
Faculty of Medicine
University of Bonn
Sigmund Freud Str. 25
Bonn
53105
Germany

Phone	+49 (0)228 287 15675
Email	hoerauf@microbiology-bonn.de

Prof Ohene Adjei
Scientific

Kwame Nkrumah University of Science and Technology (KNUST), and Kumasi Centre of Collaborative Research (KCCR)
University Post Office
Kumasi
-
Ghana

Phone	+ 233 (0)51 60351
Email	oadjei@africaonline.com

Study information

Study design	Double-blind randomised 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	Doxycycline treatment to eliminate Onchocerca volvulus worms that respond poorly to ivermectin: a double-blind randomised placebo-controlled trial
Study acronym	SCOOTT (Sustainable Control of Onchocerciasis Today and Tomorrow)
Study objectives	Proof that doxycycline treatment is safe, tolerable and an effective alternative for patients in whom ivermectin has failed to clear microfilariae (potentially due to worm resistance to ivermectin).
Ethics approval(s)	Committee on Human Research Publication and Ethics, Kwame Nkrumah University of Science and Technology, 15/03/2007
Health condition(s) or problem(s) studied	Onchocerciasis (river blindness)
Intervention	100 mg/day oral doxycycline or matching placebo for 6 weeks. Volunteers for this study are recruited, based on the inclusion and exclusion criteria, and treated directly in their villages (along the Pru and Lower Black Volta river basins). The study drugs are to be distributed ad personam by the research-staff and drug intake is monitored on a daily basis for 6 weeks. To assess the skin microfilarial load, skin biopsies are taken pre-treatment, 12 months and 20 months after treatment. Nodulectomies to assess the worm vitality and embryogenesis are performed 20 months after the start of drug administration. Onchocercomas will be removed under local anaesthesia in the hospital. Patients are kept in hospital for one day after operation before discharge to be observed by the surgeon. Wound dressing will continue in the villages until all wounds are healed.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Doxycycline
Primary outcome measure	Proportion of sterile or dead female O. volvulus worms in nodules from doxycycline-treated onchocerciasis patients, measured 20 months after the start of drug administration
Secondary outcome measures	Reduction or absence of microfilariae in the skin, measured 20 months after the start of drug administration
Overall study start date	01/06/2007
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	166
Key inclusion criteria	1. Males and females between 18 - 50 years 2. Good general health without any clinical condition requiring long-term medication 3. Clinical manifestation of onchocerciasis assessed by skin biopsies and palpation (at least one onchocercoma) 4. Minimum body weight 40 kg
Key exclusion criteria	1. Pregnancy (if not obvious all women are tested by dipstick chemistry: beta-human chorionic gonadotropin [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
Date of first enrolment	01/06/2007
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Germany
Ghana

Study participating centre

University of Bonn

Bonn
53105
Germany

Sponsor information

European Commission (Belgium)
Government

Research Directorate-General
Rue de la Loi 200
Bruxelles
B-1049
Belgium

Phone	+32 (0)2 299 1111
Email	rtd-inco-projects@cec.eu.int
Website	http://www.europa.eu.int
"ROR"	https://ror.org/00k4n6c32

Funders

Funder type

Government

European Commission (Belgium) (ref: INCO-CT-2006-032321)
Government organisation / National government

Alternative name(s): European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/08/2015		Yes	No