title: Efficacy and safety of intravenous meropenem and tobramycin versus ceftazidime and tobramycin in cystic fibrosis.
abstract: BACKGROUND
  Cystic fibrosis (CF) is characterized by chronic bacterial broncho-pulmonary infection. Although intravenous (i.v.) antibiotic therapy is regarded as standard treatment in CF, only few randomised trials comparing different antibiotic compounds exist.
  
  
  METHODS
  We report on a prospective multicenter interventional trial of i.v. meropenem (120 mg/kg/day) or i.v. ceftazidime (200-400 mg/kg/day), each administered together with i.v. tobramycin (9-12 mg/kg/day). Outcome measures were changes in lung function, microbiological sputum burden and blood inflammatory marker. Liver and renal function values were measured to assess safety.
  
  
  RESULTS
  One hundred eighteen patients (59/59) were included into the study with the following indications: first infection of P. aeruginosa (n=6), acute pulmonary exacerbation (n=34) and suppression therapy of chronic P. aeruginosa colonization (n=78). Both treatments improved lung function measures, bacterial sputum burden and CRP levels with no differences between treatment groups observed. A significant higher elevation for alkaline phosphatase (p<0.0001) was observed for patients in the meropenem/tobramycin group.
  
  
  CONCLUSIONS
  i.v. antibiotic therapy in CF patients with meropenem/tobramycin is as effective as with ceftazidime/tobramycin regarding lung function, microbiological sputum burden and systemic inflammatory status. Hepato-biliary function should be monitored carefully during i.v. treatment, possibly important in CF patients with pre-existing liver disease.
authors.affiliation: Children's Hospital of the Ludwig-Maximilians-University of Munich, 80377 Munich, Germany.
authors.forename: Philipp
authors.initials: P
authors.lastname: Latzin
authors.forename: Maya
authors.initials: M
authors.lastname: Fehling
authors.forename: Adolf
authors.initials: A
authors.lastname: Bauernfeind
authors.forename: Dietrich
authors.initials: D
authors.lastname: Reinhardt
authors.forename: Matthias
authors.initials: M
authors.lastname: Kappler
authors.forename: Matthias
authors.initials: M
authors.lastname: Griese
mesh_terms: D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001424:Bacterial Infections / Q000209:etiology / Q000517:prevention & control; D002097:C-Reactive Protein / Q000378:metabolism; D002442:Ceftazidime / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D003550:Cystic Fibrosis / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007262:Infusions, Intravenous; D008297:Male; D000077731:Meropenem; D011446:Prospective Studies; D013845:Thienamycins / Q000008:administration & dosage*; D014031:Tobramycin / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D013845:Thienamycins; D002097:C-Reactive Protein; D002442:Ceftazidime; D000077731:Meropenem; D014031:Tobramycin