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Ciprofloxacin plus Piperacillin Compared with Tobramycin plus Piperacillin as Empirical Therapy in Febrile Neutropenic Patients: A Randomized, Double-Blind Trial

James E. Peacock Jr., MD; Deirdre A. Herrington, MD; James C. Wade, MD; Hillard M. Lazarus, MD; Michael D. Reed, MD; Jane W. Sinclair, RN; Daniel C. Haverstock, MS; Steven F. Kowalsky, PharmD; David D. Hurd, MD; Deborah A. Cushing, RN; Colleen P. Harman, RN; and Gerald R. Donowitz, MD
[+] Article, Author, and Disclosure Information

From Wake Forest University School of Medicine, Winston-Salem, North Carolina; University of Maryland Cancer Center, Baltimore, Maryland; Ireland Cancer Center, Rainbow Babies and Children's Hospital, University Hospitals of Cleveland, and Case Western Reserve University, Cleveland, Ohio; Bayer Corp., West Haven, Connecticut; and University of Virginia Health System, Charlottesville, Virginia.

Disclosure: Bayer Corp., Pharmaceutical Division, is the manufacturer of Cipro (ciprofloxacin), a drug in one of the treatment regimens investigated in this study.

Acknowledgments: The following investigators from the named institutions contributed patients to the study: Victor Fainstein, Infectious Disease Association of Houston; Daniel Kett, University of Miami School of Medicine; Princy Kumar and Eduardo Vejas, Georgetown University Medical Center; and Alan Saven, Scripps Clinical Research Foundation.

Grant Support: By Bayer Corp., Pharmaceutical Division.

Requests for Single Reprints: Gerald R. Donowitz, MD, University of Virginia Health System, Division of Infectious Diseases, PO Box 801343, Charlottesville, VA 22908-1343.

Potential Financial Conflicts of Interest:Employment: D.C. Haverstock, S.F. Kowalsky. Consultancies: J.C. Wade. Honoraria: J.C. Wade, M.D. Reed. Grants Received or Pending: J.C. Wade, J.E. Peacock, D.A. Herrington, H.M. Lazarus, M.D. Reed, D.D. Hurd, D.A. Cushing, C.P. Harman, G.R. Donowitz.

Current Author Addresses: Drs. Peacock, Herrington, and Hurd and Ms. Sinclair: Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157-1042.

Dr. Wade: Fred Hutchinson Cancer Center, P.O. Box 19024, Seattle, WA 98109.

Drs. Lazarus and Reed: University Hospitals of Cleveland, 11100 Euclid Avenue, Cleveland, OH 44106.

Dr. Donowitz and Ms. Harman: University of Virginia Health System, P.O. Box 801343, Charlottesville, VA 22908.

Dr. Kowalsky and Mr. Haverstock: Bayer Corporation, 400 Morgan Lane, West Haven, CT 06516-4175.

Ms. Cushing: 18 Channel View Road, Cape Elizabeth, ME 04107.

Author Contributions: Conception and design: J.E. Peacock, J.C. Wade, S.F. Kowalsky, G.R. Donowitz.

Analysis and interpretation of the data: J.E. Peacock, D.A. Herrington, J.C. Wade, H.M. Lazarus, M.D. Reed, D.C. Haverstock, S.F. Kowalsky, G.R. Donowitz.

Drafting of the article: S.F. Kowalsky, C.P. Harman, G.R. Donowitz.

Critical revision of the article for important intellectual content: J.E. Peacock, D.A. Herrington, J.C. Wade, H.M. Lazarus, M.D. Reed, S.F. Kowalsky, G.R. Donowitz.

Final approval of the article: J.E. Peacock, J.C. Wade, S.F. Kowalsky, G.R. Donowitz.

Provision of study materials or patients: J.E. Peacock, D.A. Herrington, J.C. Wade, H.M. Lazarus, M.D. Reed, J.W. Sinclair, D.D. Hurd, C.P. Harman, G.R. Donowitz.

Statistical expertise: D.C. Haverstock.

Obtaining of funding: J.E. Peacock, J.C. Wade, H.M. Lazarus, G.R. Donowitz.

Administrative, technical, or logistic support: M.D. Reed, J.W. Sinclair, D.A. Cushing, C.P. Harman.

Collection and assembly of data: J.C. Wade, M.D. Reed, J.W. Sinclair, S.F. Kowalsky, D.A. Cushing, C.P. Harman, G.R. Donowitz.

Ann Intern Med. 2002;137(2):77-87. doi:10.7326/0003-4819-137-2-200207160-00005
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We studied a total of 543 febrile episodes in 485 patients: 271 episodes in the ciprofloxacin–piperacillin group and 272 in the tobramycin–piperacillin group (Table 1). Patients who had acute leukemia or who underwent bone marrow transplantation accounted for most patients in each treatment group. We noted no significant differences among the numbers of patients enrolled in the strata (P > 0.2). Growth factors were used in 44% of patient-episodes in the ciprofloxacin–piperacillin group and 45% of patient-episodes in the tobramycin–piperacillin group (difference, −1 percentage point [95% CI, −10.2 to 7.3 percentage points]). Forty-eight patients were enrolled in the study more than once. Two weeks was the shortest interval between study re-entry. All patients except three, none of whom received study medication, were included in the intention-to-treat analysis.

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Grahic Jump Location
Figure 3.
Kaplan–Meier curve showing time to fever response (product limit estimate) in patients valid for efficacy in the ciprofloxacin–piperacillin group (solid line) or tobramycin–piperacillin group (dotted line).
Grahic Jump Location




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Summary for Patients

Treatment of Fever in Hospitalized Patients with Low White Blood Cell Counts

The summary below is from the full report titled “Ciprofloxacin plus Piperacillin Compared with Tobramycin plus Piperacillin as Empirical Therapy in Febrile Neutropenic Patients. A Randomized, Double-Blind Trial.” It is in the 16 July 2002 issue of Annals of Internal Medicine (volume 137, pages 77-86). The authors are JE Peacock Jr, DA Herrington, JC Wade, HM Lazarus, MD Reed, JW Sinclair, DC Haverstock, SF Kowalsky, DD Hurd, DA Cushing, CP Harman, and GR Donowitz.


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