Patients affected by cystic fibrosis and who present an initial infection of MRSA.
Conditions
Interventions
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:
Sponsors
AOU Meyer
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare by statistical methods the efficacy of a treatment eradicant against 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.;Primary end point(s): Comparing by statistical methods the efficacy of a treatment eradicant against the infection with MRSA;Timepoint(s) of evaluation of this end point: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactServizio di Fibrosi Cistica
AOU Meyer
Outcome results
None listed