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Curr Med Res Opin ; 28(12): 1921-31, 2012 Dec.
Article in English | MEDLINE | ID: mdl-23145859

ABSTRACT

OBJECTIVES: The aim of this prospective phase II, randomized, investigator-blinded study (NCT00690378) was to compare the efficacy and safety of ceftazidime-avibactam and imipenem-cilastatin in hospitalized adults with serious complicated urinary tract infection (cUTI) due to Gram-negative pathogens. PATIENTS AND METHODS: Patients aged between 18 and 90 years with cUTI were enrolled and stratified by infection type (acute pyelonephritis or other cUTI) and randomized 1:1 to receive intravenous ceftazidime 500 mg plus avibactam 125 mg every 8 hours or imipenem-cilastatin 500 mg every 6 hours. Patients meeting pre-specified improvement criteria after 4 days could be switched to oral ciprofloxacin. Patients were treated for a total of 7-14 days. The primary efficacy objective was a favorable microbiological response at the test-of-cure (TOC) visit 5-9 days post-therapy in microbiologically evaluable (ME) patients. RESULTS: Overall, 135 patients received study therapy (safety population); 62 were included in the ME population (ceftazidime-avibactam, n = 27; imipenem-cilastatin, n = 35). The predominant uropathogen was Escherichia coli. Favorable microbiological response was achieved in 70.4% of ME patients receiving ceftazidime-avibactam and 71.4% receiving imipenem-cilastatin at the TOC visit (observed difference -1.1% [95% CI: -27.2%, 25.0%]). Among ME patients with ceftazidime-resistant uropathogens, response was observed in 6/7 (85.7%) receiving ceftazidime-avibactam. Adverse events were observed in 67.6% and 76.1% of patients receiving ceftazidime-avibactam and imipenem-cilastatin, respectively. Limitations of the study include the small number of patients in the ME population. CONCLUSION: The results suggest that the efficacy and safety of ceftazidime-avibactam may be similar to that of imipenem-cilastatin.


Subject(s)
Anti-Bacterial Agents , Azabicyclo Compounds , Ceftazidime , Cilastatin , Escherichia coli Infections/drug therapy , Escherichia coli , Imipenem , Protease Inhibitors , Pyelonephritis/drug therapy , Urinary Tract Infections/drug therapy , Acute Disease , Adolescent , Adult , Aged , Aged, 80 and over , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/adverse effects , Azabicyclo Compounds/administration & dosage , Azabicyclo Compounds/adverse effects , Ceftazidime/administration & dosage , Ceftazidime/adverse effects , Cilastatin/administration & dosage , Cilastatin/adverse effects , Drug Therapy, Combination/methods , Female , Humans , Imipenem/administration & dosage , Imipenem/adverse effects , Male , Middle Aged , Prospective Studies , Protease Inhibitors/administration & dosage , Protease Inhibitors/adverse effects
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