Eradication of early P. aeruginosa infection in children <7 years of age with cystic fibrosis: The early study
Publikation: Beitrag in Fachzeitschrift › Forschungsartikel › Beigetragen › Begutachtung
Beitragende
- Klinik und Poliklinik für Kinder- und Jugendmedizin
- University of Toronto
- Universität Zürich
- University of Montreal
- Yaroslavl's Children's Clinical Hospital
- Novartis AG
- RJMMD Consulting
- University of Szeged
- Somogy Megyei Kaposi Mor Oktato
- Kazan State Medical University
- Voronezh Burdenko Medical Academy
- IRCCS Fondazione Ca'Granda – Ospedale Maggiore Policlinico - Milano
- Groupe hospitalier Pellegrin
- University of Debrecen
- Clinical Research Center
- Universitätsklinikum Carl Gustav Carus Dresden
- Assistance publique – Hôpitaux de Paris
- Hippokrateio
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.
Details
Originalsprache | Englisch |
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Seiten (von - bis) | 78-85 |
Seitenumfang | 8 |
Fachzeitschrift | Journal of cystic fibrosis |
Jahrgang | 18 |
Ausgabenummer | 1 |
Publikationsstatus | Veröffentlicht - Jan. 2019 |
Peer-Review-Status | Ja |
Externe IDs
PubMed | 29685813 |
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Schlagworte
ASJC Scopus Sachgebiete
Schlagwörter
- Early eradication, Paediatric patient, Placebo-controlled, Recurrence, Tobramycin inhalation solution