To evaluate the efficacy and tolerability of intravenous empiric treatment with meropenem compared with ceftazidimetobramycin in patients with hospital-acquired lower respiratory tract infections.
Prospective, nonblind, randomized trial.
Multicenter trial conducted at 22 centers.
Two hundred eleven patients were enrolled and 121 were evaluable for the analysis of both clinical and bacteriologic efficacy.
One hundred four patients were randomized to receive intravenous meropenem (1000 mg) every 8 hrs and 107 patients were randomized to receive intravenous ceftazidime (2000 mg) plus tobramycin (1 mg/kg) every 8 hrs. Sixty-three meropenem-treated patients and 58 ceftazidime-tobramycin-treated patients were eligible for the analysis of clinical and bacteriologic efficacy. In the ceftazidime-tobramycin group, 32 (55%) evaluable patients received more than six doses of tobramycin, 24 (41%) received six doses or fewer, and two (3%) did not receive any tobramycin.
The analysis of efficacy was based on the clinical and bacteriologic responses at the end of treatment. Satisfactory clinical responses occurred in 56 (89%) of 63 of the meropenem-treated patients and in 42 (72%) of 58 of the ceftazidime-tobramycin-treated patients (p = .04). Corresponding bacteriologic response rates were 89% and 67%, respectively (p = .006). The frequency and profile of drug-related adverse events was similar across treatment groups. Seizures were reported in three meropenem-treated patients, but these seizures were considered by the investigator to be unrelated to treatment.
Meropenem is well tolerated and more efficacious than the combination of ceftazidime and tobramycin for the initial empiric treatment of hospital-acquired bacterial pneumonia. (Crit Care Med 1997; 25:1663-1670)
For the Meropenem Lower Respiratory Infection Group*.
From Orlando Regional Medical Center, Orlando, FL (Dr. Sieger); Queens Medical Center, University of Hawaii, School of Medicine, and St. Francis Medical Center, Honolulu, HI (Dr. Berman); Division of Infectious Disease, Mercy Hospital, Baltimore, MD (Dr. Geckler); and Barberton Citizens Hospital, Barberton, OH (Dr. Farkas).
*Members of the Meropenem Lower Respiratory Infection Group include: Harold W. Barkman, Jr, MD (University of Kansas Medical Center, Kansas City, KS); Nicholas Christou, MD (Royal Victoria Hospital, Montreal, Quebec); F. Robert Fekety, MD (University of Michigan Hospitals, Ann Arbor, MI); Joseph G. Jemsek, MD (The Nalle Clinic, Charlotte, NC); Richard J. Maunder, MD (Harborview Medical Center, Seattle, WA); David M. Parenti, MD (George Washington University Medical Center, Washington, DC); James S. Tan, MD (Akron Infectious Disease Inc, Akron, OH); Bienvienido G. Yangco, MD (University of South Florida College of Medicine, Tampa, FL); Joe E. Whitaker, MD (Vencor Hospital, Tampa, FL); Steven C. Bowman, MD (Mease Health Care at Countryside, Safety Harbor, FL); C. Andrew DeAbate, MD (Medical Research Center, New Orleans, LA); Felix A. Sarubbi, Jr, MD (James H. Quillen College of Medicine, Johnson City, TN); Timothy C. Fabian, MD (University of Tennessee Health Science Center, Memphis, TN); Peter Samuel Kussin, MD (Duke University Medical Center, Durham, NC); Gordon M. Trenholme, MD (Rush-Presbyterian-St. Luke, Chicago, IL); Richard Neil Greenberg, MD (University of Kentucky, Lexington, KY); Carlos H. Ramirez-Rhonda, MD (San Juan VA Medical Center, San Juan, PR); and Harogopal Thadepalli, MD (Charles R. Drew University of Medicine and Science, Los Angeles, CA).
Supported, in part, by Zeneca Pharmaceuticals.
Address requests for reprints to: Barry Sieger, MD, Department of Medicine and Pharmacy, Orlando Regional Medical Center, 1414 South Orange Avenue, Orlando, FL 32806.