Tic Disorders | Efficacy of Amoxicilline/Clavulanic Acid in Patients Affected by Tic Disorder Colonized by Group A Streptococcus
Tic Disorders research study
What is the primary objective of this study?
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 treatment with antibiotics in reducing severity of tics and associated neuropsychiatric symptoms in patients with a tic disorder colonised by GAS. Primary Objective: Test the hypothesis that antibiotic treatment of GAS colonisation compared to placebo is associated with a larger reduction of tic and associated neuropsychiatric symptoms in the short-term (1 month) in patients with a tic disorder colonised by GAS. Secondary Objective: Test the hypothesis that antibiotic treatment of GAS colonisation is superior to placebo in the long-term (1 year) reduction of tic and associated neuropsychiatric symptoms in patients with a tic disorder colonized by GAS. Patients affected by a chronic tic disorder followed in the EMTICS- Longitudinal Course Study that show a positive culture for GAS at any microbiological examination during their follow-up will be considered eligible for the treatment trial. Patients showing GAS positivity will be invited to participate in the clinical trial. The patients enrolled will be randomly assigned to antibiotic or placebo in a 1:1 ratio. All participating patients will undergo a microbiological, serological and clinical assessment 1 month after the date of entering in the treatment trial (i.e. around 20 days after the end of treatment). Then, the patients will be followed with clinical, laboratory and microbiological assessments every four months for 1 year. Patients will be deblinded at the end of the treatment trial follow-up (1 year after the recruitment). Patients who will develop a true GAS infection or who otherwise need to be prescribed antibiotics for any clinical reason during the follow-up will be withdrawn from the study and immediately deblinded. Data of such patients would, however, remain part of the study analyses, following the intention-to-treat principle.
Who is eligible to participate?
Inclusion Criteria: - 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 Criteria: - 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Amoxicillin-Potassium Clavulanate CombinationAmoxicillin-Potassium Clavulanate Combination will be prescribed at the dose of 25/3.6 mg/kg/day for 10 days, 2 times/day, as oral suspension.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
AntibioticAmoxicillin-Potassium Clavulanate Combination
Start Date: March 2013
Completed Date: May 2017
Primary Outcome: Severity of tic disorder
Secondary Outcome: Severity of tic disorder
Study sponsors, principal investigator, and references
Principal Investigator: Francesco Cardona, MD
Lead Sponsor: University of Roma La Sapienza
Bombaci M, Grifantini R, Mora M, Reguzzi V, Petracca R, Meoni E, Balloni S, Zingaretti C, Falugi F, Manetti AG, Margarit I, Musser JM, Cardona F, Orefici G, Grandi G, Bensi G. Protein array profiling of tic patient sera reveals a broad range and enhanced immune response against Group A Streptococcus antigens. PLoS One. 2009 Jul 22;4(7):e6332. doi: 10.1371/journal.pone.0006332.