Evidence map›Paper›PMID 19470318›Full record

Trial reportContemporary clinical trials2009

Early anti-pseudomonal acquisition in young patients with cystic fibrosis: rationale and design of the EPIC clinical trial and observational study'.

Miriam M Treggiari, Margaret Rosenfeld, Nicole Mayer-Hamblett, George Retsch-Bogart, Ronald L Gibson, Judy Williams, Julia Emerson, Richard A Kronmal, Bonnie W Ramsey, EPIC Study Group

Registry-linked trialOpen access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00097773 (Effectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas Aeruginosa Airway Infection in Young Patients With Cystic Fibrosis), which is not on this map. Cited by 68 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 7 pooled it
6.9field-weighted citation impact, top 3% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT00097773 phase2completednot on this map

Effectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas Aeruginosa Airway Infection in Young Patients With Cystic Fibrosis

TypeinterventionalSponsorSeattle Children's HospitalRan2004 to 2009Enrolled304ConditionsCystic Fibrosis, Pulmonary Disease, Chronic ObstructiveArmsTobramycin solution for inhalation (TOBI), Oral placebo, Oral ciprofloxacin
3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 7 syntheses or guidelines pooled it, 134 citations in OpenAlex.

  1. Pooled it
  2. Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Pooled it
  4. Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis.The Cochrane database of systematic reviews · 2018
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Oral anti-pseudomonal antibiotics for cystic fibrosis.The Cochrane database of systematic reviews · 2016
    Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Impact of Sustained Eradication of New Pseudomonas aeruginosa Infection on Long-term Outcomes in Cystic Fibrosis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2015
    Trial
  12. Trial
  13. Trial
  14. Risk factors for age at initial Pseudomonas acquisition in the cystic fibrosis epic observational cohort.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2012
    Trial
  15. Trial
  16. Trial
  17. Trial
  18. Article
  19. Article
  20. Article

8 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Miriam M TreggiariDepartment of Anesthesiology and Pain Medicine, University of Washington School of Medicine, Seattle, WA 98104, USA. treggmm@u.washington.edu
Margaret Rosenfeld
Nicole Mayer-Hamblett
George Retsch-Bogart
Ronald L Gibson
Judy Williams
Julia Emerson
Richard A Kronmal
Bonnie W Ramsey
EPIC Study Group
University of Washington · USSeattle Children's Hospital · USCystic Fibrosis Foundation · USUniversity of North Carolina at Chapel Hill · US

Funding

INSTITUTE FOR TRANSLATIONAL HEALTH SCIENCE (UL1): BPCAUL1RR025014 · NCRR · UNIVERSITY OF WASHINGTON · PI DISIS, MARY L. · 2007 to 2011
$51.5M
Early Antipseudomonal Therapy in Cystic FibrosisU01HL080310 · NHLBI · SEATTLE CHILDREN'S HOSPITAL · PI RAMSEY, BONNIE W · 2004 to 2008
$6.5M
NCRR NIH HHS ULI-RR2501401NHLBI NIH HHS U01 HL080310NHLBI NIH HHS U01-HL080310
6 · The paper itself

Abstract

backgroundThe primary cause of morbidity and mortality in patients with cystic fibrosis (CF) is progressive obstructive pulmonary disease due to chronic endobronchial infection, particularly with Pseudomonas aeruginosa (Pa). Risk factors for and clinical impact of early Pa infection in young CF patients are less well understood. PURPOSE: The present studies are designed to evaluate risk factors and outcomes associated with early Pa acquisition, and the benefits and harms of four anti-pseudomonal treatment regimens in young CF patients initiated after the first Pa positive respiratory culture.

methodsThe Early Pseudomonas Infection Control (EPIC) program consists of two studies, a randomized multicenter trial in CF patients ages 1-12 years at first isolation of Pa from a respiratory culture, and a longitudinal cohort study enrolling Pa-negative patients. Using a factorial design, trial participants are assigned for 18 months to either anti-pseudomonal treatment on a scheduled quarterly basis (cycled therapy) or based on recovery of Pa from quarterly respiratory cultures (culture-based therapy). The study drugs include inhaled tobramycin (300 mg BID) for 28 days, combined with either oral ciprofloxacin (15-20 mg/kg BID) or oral placebo for 14 days. The primary endpoints of the trial are the time to pulmonary exacerbation requiring IV antibiotics or hospitalization for respiratory symptoms, and the proportion of patients with new Pa-positive respiratory cultures during the study. The broad goals of the observational study are to describe the risk factors and outcomes associated with early acquisition of Pa. 306 patients were randomized in the clinical trial and 1787 were enrolled in the cohort study.

conclusionsThese companion studies will provide valuable epidemiological and microbiological information on early CF lung disease and Pa acquisition, and safety and clinical efficacy data on anti-pseudomonal treatment strategies for early Pa infections in the airways of young children with CF.

Indexed as

Pseudomonas aeruginosaAge FactorsAnti-Bacterial AgentsChildChild, PreschoolCiprofloxacinCohort StudiesCystic FibrosisDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansInfantLongitudinal StudiesMaleAnti-Bacterial AgentsCiprofloxacinTobramycin

Identifiers

PMID19470318
PMCPMC2783320
OpenAlexW2058103582

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.