title: Early antibiotic treatment for Pseudomonas aeruginosa eradication in patients with cystic fibrosis: a randomised multicentre study comparing two different protocols.
abstract: BACKGROUND
  Pseudomonas aeruginosa chronic pulmonary infection is an unfavourable event in cystic fibrosis. Bacterial clearance is possible with an early antibiotic treatment upon pathogen isolation. Currently, no best practice exists for early treatment. The efficacy of two different regimens against initial P. aeruginosa infection was assessed.
  
  
  METHODS
  In a randomised, open-label, parallel-group study involving 13 centres, the superiority of inhaled tobramycin/oral ciprofloxacin compared with inhaled colistin/oral ciprofloxacin (reference treatment) over 28 days was evaluated. Patients were eligible if they were older than 1 year with first or new P. aeruginosa isolation. Treatments were assigned equally by centralised balanced randomisation, stratified by age and forced expiratory volume in 1 s values. The participants and those giving the intervention were not masked to arm assignments. The primary endpoint was P. aeruginosa eradication, defined as three successive negative cultures in 6 months. Analysis was by intention to treat. This trial was registered with EudraCT, number 2008-006502-42.
  
  
  RESULTS
  105 patients were assigned to inhaled colistin/oral ciprofloxacin (arm A) and 118 to inhaled tobramycin/oral ciprofloxacin (arm B). All patients were analysed. P. aeruginosa was eradicated in 66 (62.8%) patients in arm A and in 77 (65.2%) in arm B (OR 0.90, 95% CI 0.52 to 1.55, p=0.81). Following treatment, an increase in Stenotrophomonas maltophilia was noted (OR 3.97, 95% CI 2.27 to 6.94, p=0.001) with no differences between the two arms (OR 0.89, 95% CI 0.44 to 1.78, p=0.88).
  
  
  CONCLUSIONS
  No superiority of treatment under study was demonstrated in comparison to the reference treatment. Early eradication treatment was associated with an increase in S maltophilia.
authors.affiliation: Cystic Fibrosis Centre, Anna Meyer Children's University Hospital, Viale Pieraccini 24, Firenze 50139, Italy. g.taccetti@meyer.it
authors.forename: Giovanni
authors.initials: G
authors.lastname: Taccetti
authors.forename: Elisa
authors.initials: E
authors.lastname: Bianchini
authors.forename: Lisa
authors.initials: L
authors.lastname: Cariani
authors.forename: Roberto
authors.initials: R
authors.lastname: Buzzetti
authors.forename: Diana
authors.initials: D
authors.lastname: Costantini
authors.forename: Francesca
authors.initials: F
authors.lastname: Trevisan
authors.forename: Lucia
authors.initials: L
authors.lastname: Zavataro
authors.forename: Silvia
authors.initials: S
authors.lastname: Campana
mesh_terms: D000280:Administration, Inhalation; D000284:Administration, Oral; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D002648:Child; D002675:Child, Preschool; D002939:Ciprofloxacin / Q000008:administration & dosage*; D003091:Colistin / Q000008:administration & dosage*; D003550:Cystic Fibrosis / Q000382:microbiology*; D004359:Drug Therapy, Combination; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D007223:Infant; D008297:Male; D011552:Pseudomonas Infections / Q000188:drug therapy*; D011550:Pseudomonas aeruginosa / Q000302:isolation & purification; D020615:Stenotrophomonas maltophilia / Q000302:isolation & purification; D014031:Tobramycin / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D002939:Ciprofloxacin; D014031:Tobramycin; D003091:Colistin