Trial reportPediatric pulmonology2013
Standard care versus protocol based therapy for new onset Pseudomonas aeruginosa in cystic fibrosis.
Trial report in Pediatric pulmonology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 6 syntheses or guidelines pooled it, 36 citations in OpenAlex.
- Inhaled anti-pseudomonal antibiotics for long-term therapy in cystic fibrosis.The Cochrane database of systematic reviews · 2022Pooled it
- Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis.The Cochrane database of systematic reviews · 2022Pooled it
- Treatments for preventing recurrence of infection with Pseudomonas aeruginosa in people with cystic fibrosis.The Cochrane database of systematic reviews · 2019Pooled it
- Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis.The Cochrane database of systematic reviews · 2018Pooled it
- Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis.The Cochrane database of systematic reviews · 2017Pooled it
- Oral anti-pseudomonal antibiotics for cystic fibrosis.The Cochrane database of systematic reviews · 2016Pooled it
- Azithromycin may antagonize inhaled tobramycin when targeting Pseudomonas aeruginosa in cystic fibrosis.Annals of the American Thoracic Society · 2014Trial
- Systematic Review of Antimicrobial Therapies and Clinical Outcomes inLife (Basel, Switzerland) · 2026Review
- Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis.The Cochrane database of systematic reviews · 2023Review
- Diagnosis and Management of Cystic Fibrosis Exacerbations.Seminars in respiratory and critical care medicine · 2023Review
- Epidemiologic Study of Cystic Fibrosis: 25 years of observational research.Pediatric pulmonology · 2021Review
- Treatment of Pulmonary Disease of Cystic Fibrosis: A Comprehensive Review.Antibiotics (Basel, Switzerland) · 2021Review
- Article
- Acute Pulmonary Exacerbations in Cystic Fibrosis.Seminars in respiratory and critical care medicine · 2019Review
- Prevention of chronic infection with Pseudomonas aeruginosa infection in cystic fibrosis.Current opinion in pulmonary medicine · 2019Review
- "Pathogen Eradication" and "Emerging Pathogens": Difficult Definitions in Cystic Fibrosis.Journal of clinical microbiology · 2018Article
- Inhaled anti-pseudomonal antibiotics for long-term therapy in cystic fibrosis.The Cochrane database of systematic reviews · 2018Review
- Understanding persistent bacterial lung infections: clinical implications informed by the biology of the microbiota and biofilms.Clinical pulmonary medicine · 2016Article
- Pulmonary radiographic findings in young children with cystic fibrosis.Pediatric radiology · 2015Article
- The emergence of multidrug-resistantLung India : official organ of Indian Chest SocietyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 6 institutions in 1 country.
Funding
Abstract
rationaleThe 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.
methodsEligibility 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.
resultsAs 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.
conclusionsProtocol-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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.