Sequential ciprofloxacin therapy in pediatric cystic fibrosis: Comparative study vs. ceftazidime/tobramycin in the treatment of acute pulmonary exacerbations

Deborah A. Church, Jamshed F. Kanga, Robert J. Kuhn, Thomas T. Rubio, William A. Spohn, John C. Stevens, Barbara G. Painter, Barbara E. Thurberg, Daniel C. Haverstock, Renee Y. Perroncel, Roger M. Echols, Joseph J. Chiaro, Mary M. Farrell, Michael Hoppe, Harris R. Stutman, Eliezer Nussbaum, Terry Chin, Margaret Zaleska, Margaret Guill, Valera L. HudsonNelson L. Turcios, Marian Heenehan, Bruce Schnaph, Scott Kirley, Dan Buffington, Jackie Garvin, Dennis Stokes, Bee Smith, Donna Diakin, Laura Herbert, Elizabeth Farrington, Mary Blagburn, Julie Hsu, Bhimsen Rao, Ibrahim Abdulhamid, Sandy Lauzen, May Saba, Stephen Stewart, Lois J. Craigmyle, Michael Morin, James McCarty, Daniel B. Caplan

Research output: Contribution to journalArticlepeer-review

74 Scopus citations


Background. Cystic fibrosis patients have chronic bacterial infections of the respiratory tract, most commonly Pseudomonas aeruginosa. Although controversial, administration of antibiotic therapy during acute pulmonary exacerbations is standard practice. Fluoroquinolones are currently not indicated for use in young children because of the observation of arthropathy and damage to growing cartilage in beagle puppies. Because of its activity against P. aeruginosa and excellent oral bioavailability, ciprofloxacin offers a unique therapeutic alternative for this patient population. Objective. This prospective, randomized, double blind study compared the efficacy and safety of sequential intravenous/oral ciprofloxacin vs. ceftazidime/tobramycin in hospitalized pediatric cystic fibrosis patients with an acute pulmonary exacerbation associated with P. aeruginosa infection. Methods. One hundred thirty patients (ages 5 to 17 years) were randomized to receive either iv ciprofloxacin 10 mg/kg every 8 h for 7 days followed by oral ciprofloxacin 20 mg/kg every 12 h for a minimum of 3 days or iv ceftazidime 50 mg/kg every 8 h plus iv tobramycin 3 mg/kg every 8 h for a minimum of 10 days. Clinical, bacteriologic and safety responses were assessed throughout the study. Results. All 84 patients (median age, 11 years; range, 5 to 17 years) valid for efficacy in both treatment groups demonstrated clinical improvement. Five patients experienced clinical relapses (3 ciprofloxacin, 2 ceftazidime/tobramycin) by the 2- to 4-week follow-up. Intent-to-treat analysis demonstrated similar clinical findings between the two treatment groups at both the end of therapy and follow-up. Clinical improvement correlated with improvement in pulmonary function studies and the acute clinical scoring system but not with bacteriologic eradication of Pseudomonas. DNA profiles demonstrated that irrespective of colony morphology, usually one clonal strain was associated with each patient's pulmonary exacerbation. Treatment-associated musculoskeletal events occurred with equal frequency (22% vs. 21%) in both study drug groups (n = 129), and arthralgias were within the range of rates for cystic fibrosis arthropathy. None of these events required study drug discontinuation. Conclusion. Sequential iv/oral ciprofloxin monotherapy offers a safe and efficacies alternative to standard parenteral therapy for acute pulmonary exacerbations in pediatric cystic fibrosis patients.

Original languageEnglish
Pages (from-to)97-105
Number of pages9
JournalPediatric Infectious Disease Journal
Issue number1
StatePublished - Jan 1997


  • Cystic fibrosis
  • Pseudomonas aeruginosa
  • acute pulmonary exacerbations
  • arthropathy
  • ceftazidime
  • ciprofloxacin
  • pediatrics
  • tobramycin

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Microbiology (medical)
  • Infectious Diseases


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