Condition category
Infections and Infestations
Date applied
19/01/2009
Date assigned
13/02/2009
Last edited
30/07/2015
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
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 measures

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

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

http://www.europa.eu.int

Funders

Funder type

Government

Funder name

European Commission (Belgium) (ref: INCO-CT-2006-032321)

Alternative name(s)

EC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25948064

Publication citations

Additional files

Editorial Notes