Header

UZH-Logo

Maintenance Infos

Eradication of early P. aeruginosa infection in children <7 years of age with cystic fibrosis: The early study


Ratjen, Felix; Moeller, Alexander; McKinney, Martha L; Asherova, Irina; Alon, Nipa; Maykut, Robert; Angyalosi, Gerhild; EARLY study group (2019). Eradication of early P. aeruginosa infection in children <7 years of age with cystic fibrosis: The early study. Journal of Cystic Fibrosis, 18(1):78-85.

Abstract

OBJECTIVE Antibiotic eradication treatment is the standard-of-care for cystic fibrosis (CF) patients with early Pseudomonas aeruginosa (Pa)-infection; however, evidence from placebo-controlled trials is limited. METHODS This double-blind, placebo-controlled trial randomised CF patients <7 years (N = 51) with early Pa-infection to tobramycin inhalation solution (TOBI 300 mg) or placebo (twice daily) for 28 days with an optional cross-over on Day 35. Primary endpoint was proportion of patients having throat swabs/sputum free of Pa on Day 29. RESULTS On Day 29, 84.6% patients in the TOBI versus 24.0% in the placebo group were Pa-free (p < 0.001). At the end of the cross-over period, 76.0% patients receiving TOBI in the initial 28 days were Pa-free compared to 47.8% receiving placebo initially. Adverse events were consistent with the TOBI safety profile with no differences between TOBI and placebo. CONCLUSION TOBI was effective in eradicating early Pa-infection with a favourable safety profile in young CF patients. TRIAL REGISTRATION NUMBER NCT01082367.

Abstract

OBJECTIVE Antibiotic eradication treatment is the standard-of-care for cystic fibrosis (CF) patients with early Pseudomonas aeruginosa (Pa)-infection; however, evidence from placebo-controlled trials is limited. METHODS This double-blind, placebo-controlled trial randomised CF patients <7 years (N = 51) with early Pa-infection to tobramycin inhalation solution (TOBI 300 mg) or placebo (twice daily) for 28 days with an optional cross-over on Day 35. Primary endpoint was proportion of patients having throat swabs/sputum free of Pa on Day 29. RESULTS On Day 29, 84.6% patients in the TOBI versus 24.0% in the placebo group were Pa-free (p < 0.001). At the end of the cross-over period, 76.0% patients receiving TOBI in the initial 28 days were Pa-free compared to 47.8% receiving placebo initially. Adverse events were consistent with the TOBI safety profile with no differences between TOBI and placebo. CONCLUSION TOBI was effective in eradicating early Pa-infection with a favourable safety profile in young CF patients. TRIAL REGISTRATION NUMBER NCT01082367.

Statistics

Citations

Dimensions.ai Metrics

Altmetrics

Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Children's Hospital Zurich > Medical Clinic
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:1 January 2019
Deposited On:09 Jan 2019 15:48
Last Modified:19 Jan 2019 02:06
Publisher:Elsevier
ISSN:1569-1993
OA Status:Closed
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.1016/j.jcf.2018.04.002
PubMed ID:29685813

Download

Full text not available from this repository.
View at publisher

Get full-text in a library