Status:
UNKNOWN
Efficacy of Amoxicilline/Clavulanic Acid in Patients Affected by Tic Disorder Colonized by Group A Streptococcus
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Tic Disorders
Eligibility:
All Genders
3-16 years
Phase:
NA
Brief Summary
This study is an extension of the European Multicentre Tics In Children Studies (EMTICS) COURSE study for which a separate study protocol exists; Aim of this clinical trial is to study the efficacy of...
Detailed Description
Following the few studies performed on this topic, children affected by tic disorder show a rate of Group A Streptococcus (GAS) colonization similar or slightly higher than that reported in the normal...
Eligibility Criteria
Inclusion
- Diagnosis of Tourette Syndrome or another chronic tic disorder according to DSM IV-TR criteria.
- Evidence of GAS colonization at any visit of EMTICS Longitudinal Course Study.
- Either no current psychotropic medication or on stable anti-tic medication for at least 2 months before the enrolment in the trial.
- Able (in the Investigators opinion) and willing to comply with all study requirements.
Exclusion
- Children and/or parents are unable to understand and comply with protocol
- Any antibiotic treatment for any reason during the last month before enrolment in the trial.
- Clinical manifestations of pharyngitis or other streptococcal infections at moment of enrolment in the trial.
- Known or suspected hypersensitivity to penicillin or other β-lactam antibacterials, a history of amoxicillin-clavulanate-associated cholestatic jaundice or hepatic dysfunction.
- Known and/or suspected renal or hepatic impairment (due to the potential for drug-related toxicity in patients with such a condition).
- Scheduled elective surgery or other procedures requiring general anaesthesia during the study.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Participants who have participated in another research study involving an investigational product in the past 12 weeks
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2017
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01860300
Start Date
March 1 2013
End Date
May 1 2017
Last Update
May 11 2016
Active Locations (1)
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1
Department of Pediatrics and Child Neuropsychiatry
Rome, Italy, 00185