MRSA study.

• Register: EUCTR
• Last refreshed on: 30 April 2018
• Main ID: EUCTR2013-000219-25-IT
• Date of registration: 12/04/2018
• Prospective Registration: No
• Primary sponsor: AOU Meyer
• Public title: MRSA study.
• Scientific title: Early eradication of S. Aureus (MRSA) in patients with cystic fibrosis: a randomized multicenter study.
• Date of first enrolment: 18/07/2013
• Target sample size: 100
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000219-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Only observation without treatment Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Italy

Contacts

• Name: Servizio di Fibrosi Cistica
• Affiliation: AOU Meyer

• Name: Servizio di Fibrosi Cistica
• Affiliation: AOU Meyer

Key inclusion & exclusion criteria

Inclusion criteria:
Patients affected by cystic fibrosis who can demonstrate regular visits to the Tuscan regional center of CF, older than 4 years and not infected by Burkholderia cepacia complex and with no clinical signs of respiratory exacerbation.
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
CF patients that, at MRSA isolation, show evidence of respiratory exacerbation, history of antibiotic hypersensitivity or adverse reaction to antibiotics, liver cirrhosis or abnormal liver function test results at study entry, abnormal kidney function at study entry, pregnancy, lung/liver transplantation


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients affected by cystic fibrosis and who present an initial infection of MRSA.

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Intervention(s)

Product Name: Rifampin
Pharmaceutical Form: Tablet
INN or Proposed INN: RIFAMPICIN
CAS Number: 13292-46-1

Product Name: Trimethoprim-sulfamethoxazole
Pharmaceutical Form: Tablet
INN or Proposed INN: SULFAMETHOXAZOLE
CAS Number: 723-46-6
Other descriptive name: TRIMETHOPRIM

Product Name: minocycline
Pharmaceutical Form: Tablet
CAS Number: 13614-98-7
Other descriptive name: MINOCYCLINE HYDROCHLORIDE

Primary Outcome(s)

Primary end point(s): Comparing by statistical methods the efficacy of a treatment eradicant against the infection with MRSA

Secondary Objective: Evaluate the sensitivity and microbiological resistance of MRSA in the first isolation.
Evaluate the possible acquisition of other pathogens during the eradication treatment.
Evaluate the beneficial effects of eradication therapy on lung function.

Main Objective: To compare by statistical methods the efficacy of a treatment eradicant against infection with MRSA

Timepoint(s) of evaluation of this end point: 3 years

Secondary Outcome(s)

Secondary end point(s): To evaluate MRSA antibiotic susceptibility and molecular characteristics (SCCmec type) at initial infection that could be involved in persistence on a large number of MRSA strains isolated from CF airways

Timepoint(s) of evaluation of this end point: 3 years

Secondary ID(s)

MRSA

Source(s) of Monetary Support

Fondazione Italiana per la ricerca sulla fibrosi cistica