Comparative Efficacies and Tolerabilities of Intravenous Azithromycin Plus Ceftriaxone and Intravenous Levofloxacin with Step-Down Oral Therapy for Hospitalized Patients with Moderate to Severe Community-Acquired Pneumonia

Authors: Marcus Zervos; Lionel A. Mandell¹; Peter S. Vrooman²; Charles P. Andrews³; Andrew McIvor⁴; Ramzan H. Abdulla⁵; Pascal J. de Caprariis⁶; Charles A. Knirsch⁶; Guy W. Amsden⁷; Michael S. Niederman⁸; Hartmut Lode⁹

Source: Treatments in Respiratory Medicine, Volume 3, Number 5, 2004 , pp. 329-336(8)

Publisher: Adis International

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Abstract:

Objective: To compare the efficacy and tolerability of ceftriaxone plus azithromycin with those of levofloxacin in the treatment of hospitalized patients with moderate to severe community-acquired pneumonia (CAP).

Design: Randomized, open-label multicenter trial with 1 : 1 treatment allocation in an inpatient setting.

Patients: 212 male or female inpatients with a clinical diagnosis of CAP were included in the study. In each treatment group >50% of patients had a pneumonia severity index of IV or V.

Interventions: Open-label treatment with either intravenous (IV) ceftriaxone 1g and IV azithromycin 500mg daily or IV levofloxacin 500mg daily. Patients who improved clinically were switched to oral follow-on therapy with either azithromycin 500 mg/day or levofloxacin 500 mg/day. At the clinician’s discretion, oral cefuroxime axetil was added to the treatment regimen of patients who received oral azithromycin if a macrolide resistant pneumococcal isolate was documented.

Results: Overall, both study treatments were well tolerated. Favorable clinical outcomes in clinically evaluable patients were demonstrated in 91.5% of patients treated with ceftriaxone plus azithromycin and 89.3% (95% CI -7.1%, 11.4%) of patients treated with levofloxacin at the end of therapy visit and in 89.2% and 85.1% (95% CI -6.7%, 14.8%) patients, respectively, at the end of study visit. Bacteriological eradication rates for both treatments were equivalent with the exception of Streptococcus pneumoniae; 44% of isolates were eradicated with levofloxacin compared with 100% of isolates with ceftriaxone plus azithromycin.

Conclusions: As acknowledged by international CAP treatment guidelines, the combination of a third-generation cephalosporin and a macrolide is at least as efficacious as monotherapy with a fluoroquinolone with enhanced anti-pneumococcal activity, for hospitalized patients with moderate to severe CAP. Combined medication with a macrolide and third-generation cephalosporin may be preferred over fluoroquinolones as first-line therapy of hospitalized patients with CAP to minimize the development of multiresistant nosocomial Gram-negative bacilli.

Keywords: Community acquired pneumonia; Azithromycin; Ceftriaxone; Levofloxacin; Antibacterials; Quinolones; Cephalosporins; Macrolides

Document Type: Research article

Affiliations: 1: 3 Henderson General Hospital, Hamilton, Ontario, Canada 2: 4 ALL-TRIALS Clinical Research, LLC, Winston-Salem, North Carolina, USA 3: 5 Lung Diagnostics Ltd, San Antonio, Texas, USA 4: 6 Halifax Infirmary, Queen Elizabeth II Health Science Center, Halifax, Nova Scotia, Canada 5: 7 Regina General Hospital, Regina, Saskatchewan, Canada 6: 8 US Pharmaceuticals Group, Pfizer Inc., New York, New York, USA 7: 9 Clinical Pharmacology Research Center, Bassett Healthcare, Cooperstown, New York, USA 8: 10 Pulmonary and Critical Care Medicine, Winthrop University Hospital, Mineola, New York, USA 9: 11 Abteilung Pneumologie, Krankenhaus Heckeshorn, Berlin, Germany

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