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Antimicrobial Agents and Chemotherapy, July 2000, p. 1796-1802, Vol. 44, No. 7
0066-4804/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.

Clinical Efficacy of Intravenous followed by Oral Azithromycin Monotherapy in Hospitalized Patients with Community-Acquired Pneumonia

Joseph Plouffe,1 Douglas B. Schwartz,2 Antonia Kolokathis,3 Bruce W. Sherman,4 Paul M. Arnow,5 John A. Gezon,6 Byungse Suh,7 Antonio Anzuetto,8 Richard N. Greenberg,9 Michael Niederman,10 Joseph A. Paladino,11 Julio A. Ramirez,12 Jill Inverso,3 Charles A. Knirsch,3,* and the Azithromycin Intravenous Clinical Trials Groupdagger

Ohio State University, Columbus,1 and Mt. Sinai Medical Center, Cleveland,4 Ohio; Albany Medical College, Albany,2 Pfizer Pharmaceutical Group, New York,3 Winthrop Hospital, Mineola,10 and Millard Fillmore Suburban Hospital, University at Buffalo, Buffalo,11 New York; University of Chicago, Chicago, Illinois5; Salt Lake Utah Research Project, Salt Lake City, Utah6; Temple University, Philadelphia, Pennsylvania7; University of Texas at San Antonio, San Antonio, Texas8; and University of Kentucky, Lexington,9 and University of Louisville, Louisville,12 Kentucky

Received 7 December 1999/Returned for modification 17 February 2000/Accepted 29 March 2000

The purpose of this study was to evaluate intravenous (i.v.) azithromycin followed by oral azithromycin as a monotherapeutic regimen for community-acquired pneumonia (CAP). Two trials of i.v. azithromycin used as initial monotherapy in hospitalized CAP patients are summarized. Clinical efficacy is reported from an open-label randomized trial of azithromycin compared to cefuroxime with or without erythromycin. Bacteriologic and clinical efficacy results are also presented from a noncomparative trial of i.v. azithromycin that was designed to give additional clinical experience with a larger number of pathogens. Azithromycin was administered to 414 patients: 202 and 212 in the comparative and noncomparative trials, respectively. The comparator regimen was used as treatment for 201 patients; 105 were treated with cefuroxime alone and 96 were given cefuroxime plus erythromycin. In the comparative trial, clinical outcome data were available for 268 evaluable patients with confirmed CAP at the 10- to 14-day visit, with 106 (77%) of the azithromycin patients cured or improved and 97 (74%) of the comparator patients cured or improved. Mean i.v. treatment duration and mean total treatment duration (i.v. and oral) for the clinically evaluable patients were significantly (P < 0.05) shorter for the azithromycin group (3.6 days for the i.v. group and 8.6 days for the i.v. and oral group) than for the evaluable patients given cefuroxime plus erythromycin (4.0 days for the i.v. group and 10.3 days for the i.v. and oral group). The present comparative study demonstrates that initial therapy with i.v. azithromycin for hospitalized patients with CAP is associated with fewer side effects and is equal in efficacy to a 1993 American Thoracic Society-suggested regimen of cefuroxime plus erythromycin when the erythromycin is deemed necessary by clinicians.

* Corresponding author. Mailing address: Pfizer Inc., Mailstop 235/14/5, 235 East 42nd St., New York, NY 10019. Phone: (212) 733-4231. Fax: (212) 573-5916. E-mail: Charles.knirsch{at}pfizer.com.

dagger Members are listed in the appendix.

Antimicrobial Agents and Chemotherapy, July 2000, p. 1796-1802, Vol. 44, No. 7
0066-4804/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.


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