Early eradication of S. Aureus (MRSA) in patients with cystic fibrosis: a randomized multicenter study.

INTERVENTION: 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 CONDITION: Patients affected by cystic fibrosis and who present an initial infection of MRSA. Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: Main Objective: To compare by statistical methods the efficacy of a treatment eradicant against infection with MRSA 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. Timepoint(s) of evaluation of this end point: 3 years SECONDARY OUTCOME: 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 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