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Standard care versus protocol based therapy for new onset Pseudomonas aeruginosa in cystic fibrosis.

Publication ,  Journal Article
Mayer-Hamblett, N; Rosenfeld, M; Treggiari, MM; Konstan, MW; Retsch-Bogart, G; Morgan, W; Wagener, J; Gibson, RL; Khan, U; Emerson, J; EPIC, ...
Published in: Pediatr Pulmonol
October 2013

RATIONALE: The Early Pseudomonal Infection Control (EPIC) randomized trial rigorously evaluated the efficacy of different antibiotic regimens for eradication of newly identified Pseudomonas (Pa) in children with cystic fibrosis (CF). Protocol based therapy in the trial was provided based on culture positivity independent of symptoms. It is unclear whether outcomes observed in the clinical trial were different than those that would have been observed with historical standard of care driven more heavily by respiratory symptoms than culture positivity alone. We hypothesized that the incidence of Pa recurrence and hospitalizations would be significantly reduced among trial participants as compared to historical controls whose standard of care preceded the widespread adoption of tobramycin inhalation solution (TIS) as initial eradication therapy at the time of new isolation of Pa. METHODS: Eligibility criteria from the trial were used to derive historical controls from the Epidemiologic Study of CF (ESCF) who received standard of care treatment from 1995 to 1998, before widespread availability of TIS. Pa recurrence and hospitalization outcomes were assessed over a 15-month time period. RESULTS: As compared to 100% of the 304 trial participants, only 296/608 (49%) historical controls received antibiotics within an average of 20 weeks after new onset Pa. Pa recurrence occurred among 104/298 (35%) of the trial participants as compared to 295/549 (54%) of historical controls (19% difference, 95% CI: 12%, 26%, P < 0.001). No significant differences in the incidence of hospitalization were observed between cohorts. CONCLUSIONS: Protocol-based antimicrobial therapy for newly acquired Pa resulted in a lower rate of Pa recurrence but comparable hospitalization rates as compared to a historical control cohort less aggressively treated with antibiotics for new onset Pa.

Duke Scholars

Published In

Pediatr Pulmonol

DOI

EISSN

1099-0496

Publication Date

October 2013

Volume

48

Issue

10

Start / End Page

943 / 953

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Tobramycin
  • Respiratory System
  • Recurrence
  • Pseudomonas aeruginosa
  • Pseudomonas Infections
  • Prospective Studies
  • Male
  • Infant
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
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Mayer-Hamblett, N., Rosenfeld, M., Treggiari, M. M., Konstan, M. W., Retsch-Bogart, G., Morgan, W., … ESCF Investigators, . (2013). Standard care versus protocol based therapy for new onset Pseudomonas aeruginosa in cystic fibrosis. Pediatr Pulmonol, 48(10), 943–953. https://doi.org/10.1002/ppul.22693
Mayer-Hamblett, Nicole, Margaret Rosenfeld, Miriam M. Treggiari, Michael W. Konstan, George Retsch-Bogart, Wayne Morgan, Jeff Wagener, et al. “Standard care versus protocol based therapy for new onset Pseudomonas aeruginosa in cystic fibrosis.Pediatr Pulmonol 48, no. 10 (October 2013): 943–53. https://doi.org/10.1002/ppul.22693.
Mayer-Hamblett N, Rosenfeld M, Treggiari MM, Konstan MW, Retsch-Bogart G, Morgan W, et al. Standard care versus protocol based therapy for new onset Pseudomonas aeruginosa in cystic fibrosis. Pediatr Pulmonol. 2013 Oct;48(10):943–53.
Mayer-Hamblett, Nicole, et al. “Standard care versus protocol based therapy for new onset Pseudomonas aeruginosa in cystic fibrosis.Pediatr Pulmonol, vol. 48, no. 10, Oct. 2013, pp. 943–53. Pubmed, doi:10.1002/ppul.22693.
Mayer-Hamblett N, Rosenfeld M, Treggiari MM, Konstan MW, Retsch-Bogart G, Morgan W, Wagener J, Gibson RL, Khan U, Emerson J, Thompson V, Elkin EP, Ramsey BW, EPIC, ESCF Investigators. Standard care versus protocol based therapy for new onset Pseudomonas aeruginosa in cystic fibrosis. Pediatr Pulmonol. 2013 Oct;48(10):943–953.
Journal cover image

Published In

Pediatr Pulmonol

DOI

EISSN

1099-0496

Publication Date

October 2013

Volume

48

Issue

10

Start / End Page

943 / 953

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Tobramycin
  • Respiratory System
  • Recurrence
  • Pseudomonas aeruginosa
  • Pseudomonas Infections
  • Prospective Studies
  • Male
  • Infant
  • Humans