Document Detail


Effect of bronchoalveolar lavage-directed therapy on Pseudomonas aeruginosa infection and structural lung injury in children with cystic fibrosis: a randomized trial.
MedLine Citation:
PMID:  21750293     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
CONTEXT: Early pulmonary infection in children with cystic fibrosis leads to increased morbidity and mortality. Despite wide use of oropharyngeal cultures to identify pulmonary infection, concerns remain over their diagnostic accuracy. While bronchoalveolar lavage (BAL) is an alternative diagnostic tool, evidence for its clinical benefit is lacking.
OBJECTIVE: To determine if BAL-directed therapy for pulmonary exacerbations during the first 5 years of life provides better outcomes than current standard practice relying on clinical features and oropharyngeal cultures.
DESIGN, SETTING, AND PARTICIPANTS: The Australasian Cystic Fibrosis Bronchoalveolar Lavage (ACFBAL) randomized controlled trial, recruiting infants diagnosed with cystic fibrosis through newborn screening programs in 8 Australasian cystic fibrosis centers. Recruitment occurred between June 1, 1999, and April 30, 2005, with the study ending on December 31, 2009.
INTERVENTIONS: BAL-directed (n = 84) or standard (n = 86) therapy until age 5 years. The BAL-directed therapy group underwent BAL before age 6 months when well, when hospitalized for pulmonary exacerbations, if Pseudomonas aeruginosa was detected in oropharyngeal specimens, and after P. aeruginosa eradication therapy. Treatment was prescribed according to BAL or oropharyngeal culture results.
MAIN OUTCOME MEASURES: Primary outcomes at age 5 years were prevalence of P. aeruginosa on BAL cultures and total cystic fibrosis computed tomography (CF-CT) score (as a percentage of the maximum score) on high-resolution chest CT scan.
RESULTS: Of 267 infants diagnosed with cystic fibrosis following newborn screening, 170 were enrolled and randomized, and 157 completed the study. At age 5 years, 8 of 79 children (10%) in the BAL-directed therapy group and 9 of 76 (12%) in the standard therapy group had P. aeruginosa in final BAL cultures (risk difference, -1.7% [95% confidence interval, -11.6% to 8.1%]; P = .73). Mean total CF-CT scores for the BAL-directed therapy and standard therapy groups were 3.0% and 2.8%, respectively (mean difference, 0.19% [95% confidence interval, -0.94% to 1.33%]; P = .74).
CONCLUSION: Among infants diagnosed with cystic fibrosis, BAL-directed therapy did not result in a lower prevalence of P. aeruginosa infection or lower total CF-CT score when compared with standard therapy at age 5 years.
TRIAL REGISTRATION: anzctr.org.au Identifier: ACTRN12605000665639.
Authors:
Claire E Wainwright; Suzanna Vidmar; David S Armstrong; Catherine A Byrnes; John B Carlin; Joyce Cheney; Peter J Cooper; Keith Grimwood; Marj Moodie; Colin F Robertson; Harm A Tiddens;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  JAMA     Volume:  306     ISSN:  1538-3598     ISO Abbreviation:  JAMA     Publication Date:  2011 Jul 
Date Detail:
Created Date:  2011-07-13     Completed Date:  2011-07-14     Revised Date:  2014-09-17    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  United States    
Other Details:
Languages:  eng     Pagination:  163-71     Citation Subset:  AIM; IM    
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MeSH Terms
Descriptor/Qualifier:
Anti-Bacterial Agents / therapeutic use*
Australia / epidemiology
Bronchoalveolar Lavage
Child, Preschool
Cystic Fibrosis / complications*,  pathology*,  radiography
Hospitalization
Humans
Infant
Infant, Newborn
Lung / physiopathology
Lung Injury / etiology*,  prevention & control
New Zealand / epidemiology
Prevalence
Pseudomonas Infections / diagnosis*,  drug therapy*,  epidemiology
Respiratory Function Tests
Tomography, X-Ray Computed
Chemical
Reg. No./Substance:
0/Anti-Bacterial Agents
Investigator
Investigator/Affiliation:
Claire E Wainwright / ; Keith Grimwood / ; Paul W Francis / ; Carolyn Dakin / ; Joyce Cheney / ; Narelle George / ; John B Carlin / ; Colin F Robertson / ; Suzanna Vidmar / ; Rosemary Carzino / ; Marj Moodie / ; Robert Carter / ; David S Armstrong / ; Peter J Cooper / ; Karen McKay / ; A James Martin / ; Bruce Whitehead / ; Catherine A Byrnes / ; Harm A Tiddens / ; Karla Graniel / ; Krista Gerbrands / ; Lauren Mott /
Comments/Corrections
Comment In:
JAMA. 2011 Oct 26;306(16):1761; author reply 1761-2   [PMID:  22028348 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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