Efficacy and safety of intravenous meropenem and tobramycin versus ceftazidime and tobramycin in cystic fibrosis

J Cyst Fibros. 2008 Mar;7(2):142-6. doi: 10.1016/j.jcf.2007.07.001. Epub 2007 Sep 4.

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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Anti-Bacterial Agents / administration & dosage*
  • Bacterial Infections / etiology
  • Bacterial Infections / prevention & control
  • C-Reactive Protein / metabolism
  • Ceftazidime / administration & dosage*
  • Child
  • Child, Preschool
  • Cystic Fibrosis / blood
  • Cystic Fibrosis / complications
  • Cystic Fibrosis / drug therapy*
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Humans
  • Infant
  • Infant, Newborn
  • Infusions, Intravenous
  • Male
  • Meropenem
  • Prospective Studies
  • Thienamycins / administration & dosage*
  • Tobramycin / administration & dosage*
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents
  • Thienamycins
  • C-Reactive Protein
  • Ceftazidime
  • Meropenem
  • Tobramycin