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 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. Hudson & 22 others Nelson 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 journalArticle

66 Citations (Scopus)

Abstract

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
Volume16
Issue number1
DOIs
StatePublished - Jan 1997

Fingerprint

Tobramycin
Ceftazidime
Ciprofloxacin
Cystic Fibrosis
Pediatrics
Lung
Pseudomonas aeruginosa
Joint Diseases
Therapeutics
Safety
Pseudomonas Infections
Fluoroquinolones
Arthralgia
Pseudomonas
Double-Blind Method
Bacterial Infections
Pharmaceutical Preparations
Respiratory System
Biological Availability
Cartilage

Keywords

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

ASJC Scopus subject areas

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

Cite this

Sequential ciprofloxacin therapy in pediatric cystic fibrosis : Comparative study vs. ceftazidime/tobramycin in the treatment of acute pulmonary exacerbations. / Church, Deborah A.; Kanga, Jamshed F.; Kuhn, Robert J.; Rubio, Thomas T.; Spohn, William A.; Stevens, John; Painter, Barbara G.; Thurberg, Barbara E.; Haverstock, Daniel C.; Perroncel, Renee Y.; Echols, Roger M.; Chiaro, Joseph J.; Farrell, Mary M.; Hoppe, Michael; Stutman, Harris R.; Nussbaum, Eliezer; Chin, Terry; Zaleska, Margaret; Guill, Margaret; Hudson, Valera L.; Turcios, Nelson L.; Heenehan, Marian; Schnaph, Bruce; Kirley, Scott; Buffington, Dan; Garvin, Jackie; Stokes, Dennis; Smith, Bee; Diakin, Donna; Herbert, Laura; Farrington, Elizabeth; Blagburn, Mary; Hsu, Julie; Rao, Bhimsen; Abdulhamid, Ibrahim; Lauzen, Sandy; Saba, May; Stewart, Stephen; Craigmyle, Lois J.; Morin, Michael; McCarty, James; Caplan, Daniel B.

In: Pediatric Infectious Disease Journal, Vol. 16, No. 1, 01.1997, p. 97-105.

Research output: Contribution to journalArticle

Church, DA, Kanga, JF, Kuhn, RJ, Rubio, TT, Spohn, WA, Stevens, J, Painter, BG, Thurberg, BE, Haverstock, DC, Perroncel, RY, Echols, RM, Chiaro, JJ, Farrell, MM, Hoppe, M, Stutman, HR, Nussbaum, E, Chin, T, Zaleska, M, Guill, M, Hudson, VL, Turcios, NL, Heenehan, M, Schnaph, B, Kirley, S, Buffington, D, Garvin, J, Stokes, D, Smith, B, Diakin, D, Herbert, L, Farrington, E, Blagburn, M, Hsu, J, Rao, B, Abdulhamid, I, Lauzen, S, Saba, M, Stewart, S, Craigmyle, LJ, Morin, M, McCarty, J & Caplan, DB 1997, 'Sequential ciprofloxacin therapy in pediatric cystic fibrosis: Comparative study vs. ceftazidime/tobramycin in the treatment of acute pulmonary exacerbations', Pediatric Infectious Disease Journal, vol. 16, no. 1, pp. 97-105. https://doi.org/10.1097/00006454-199701000-00031
Church, Deborah A. ; Kanga, Jamshed F. ; Kuhn, Robert J. ; Rubio, Thomas T. ; Spohn, William A. ; Stevens, John ; Painter, Barbara G. ; Thurberg, Barbara E. ; Haverstock, Daniel C. ; Perroncel, Renee Y. ; Echols, Roger M. ; Chiaro, Joseph J. ; Farrell, Mary M. ; Hoppe, Michael ; Stutman, Harris R. ; Nussbaum, Eliezer ; Chin, Terry ; Zaleska, Margaret ; Guill, Margaret ; Hudson, Valera L. ; Turcios, Nelson L. ; Heenehan, Marian ; Schnaph, Bruce ; Kirley, Scott ; Buffington, Dan ; Garvin, Jackie ; Stokes, Dennis ; Smith, Bee ; Diakin, Donna ; Herbert, Laura ; Farrington, Elizabeth ; Blagburn, Mary ; Hsu, Julie ; Rao, Bhimsen ; Abdulhamid, Ibrahim ; Lauzen, Sandy ; Saba, May ; Stewart, Stephen ; Craigmyle, Lois J. ; Morin, Michael ; McCarty, James ; Caplan, Daniel B. / Sequential ciprofloxacin therapy in pediatric cystic fibrosis : Comparative study vs. ceftazidime/tobramycin in the treatment of acute pulmonary exacerbations. In: Pediatric Infectious Disease Journal. 1997 ; Vol. 16, No. 1. pp. 97-105.
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abstract = "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.",
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TY - JOUR

T1 - Sequential ciprofloxacin therapy in pediatric cystic fibrosis

T2 - Comparative study vs. ceftazidime/tobramycin in the treatment of acute pulmonary exacerbations

AU - Church, Deborah A.

AU - Kanga, Jamshed F.

AU - Kuhn, Robert J.

AU - Rubio, Thomas T.

AU - Spohn, William A.

AU - Stevens, John

AU - Painter, Barbara G.

AU - Thurberg, Barbara E.

AU - Haverstock, Daniel C.

AU - Perroncel, Renee Y.

AU - Echols, Roger M.

AU - Chiaro, Joseph J.

AU - Farrell, Mary M.

AU - Hoppe, Michael

AU - Stutman, Harris R.

AU - Nussbaum, Eliezer

AU - Chin, Terry

AU - Zaleska, Margaret

AU - Guill, Margaret

AU - Hudson, Valera L.

AU - Turcios, Nelson L.

AU - Heenehan, Marian

AU - Schnaph, Bruce

AU - Kirley, Scott

AU - Buffington, Dan

AU - Garvin, Jackie

AU - Stokes, Dennis

AU - Smith, Bee

AU - Diakin, Donna

AU - Herbert, Laura

AU - Farrington, Elizabeth

AU - Blagburn, Mary

AU - Hsu, Julie

AU - Rao, Bhimsen

AU - Abdulhamid, Ibrahim

AU - Lauzen, Sandy

AU - Saba, May

AU - Stewart, Stephen

AU - Craigmyle, Lois J.

AU - Morin, Michael

AU - McCarty, James

AU - Caplan, Daniel B.

PY - 1997/1

Y1 - 1997/1

N2 - 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.

AB - 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.

KW - acute pulmonary exacerbations

KW - arthropathy

KW - ceftazidime

KW - ciprofloxacin

KW - Cystic fibrosis

KW - pediatrics

KW - Pseudomonas aeruginosa

KW - tobramycin

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