Contact information
Type
Scientific
Primary contact
Prof Achim Hoerauf
ORCID ID
Contact details
Institute of Medical Microbiology
Immunology and Parasitology
Faculty of Medicine
University of Bonn
Sigmund Freud Str. 25
Bonn
53105
Germany
+49 (0)228 287 15675
hoerauf@microbiology-bonn.de
Type
Scientific
Additional contact
Prof Ohene Adjei
ORCID ID
Contact details
Kwame Nkrumah University of Science and Technology (KNUST)
and Kumasi Centre of Collaborative Research (KCCR)
University Post Office
Kumasi
-
Ghana
+ 233 (0)51 60351
oadjei@africaonline.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
INCO-CT-2006-032321
Study information
Scientific title
Doxycycline treatment to eliminate Onchocerca volvulus worms that respond poorly to ivermectin: a double-blind randomised placebo-controlled trial
Acronym
SCOOTT (Sustainable Control of Onchocerciasis Today and Tomorrow)
Study hypothesis
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
Committee on Human Research Publication and Ethics, Kwame Nkrumah University of Science and Technology, 15/03/2007
Study design
Double-blind randomised 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
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
Phase
Not Applicable
Drug names
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 trial start date
01/06/2007
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
166
Participant 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
Recruitment start date
01/06/2007
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Ghana
Trial participating centre
University of Bonn
Bonn
53105
Germany
Sponsor information
Organisation
European Commission (Belgium)
Sponsor details
Research Directorate-General
Rue de la Loi 200
Bruxelles
B-1049
Belgium
+32 (0)2 299 1111
rtd-inco-projects@cec.eu.int
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
European Commission (Belgium) (ref: INCO-CT-2006-032321)
Alternative name(s)
EC
Funding Body Type
unknown
Funding Body Subtype
Location
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
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25948064