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J Cyst Fibros. 2019 Jan;18(1):78-85. doi: 10.1016/j.jcf.2018.04.002. Epub 2018 Apr 21.

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

Author information

1
Division of Respiratory Medicine, Department of Pediatrics, Translational Medicine, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada. Electronic address: felix.ratjen@sickkids.ca.
2
Division of Respiratory Medicine, University Children's Hospital Zurich, Zurich, Switzerland.
3
CHU Ste-Justine, Université de Montréal, Montréal, QC, Canada.
4
Yaroslavl's Children's Clinical Hospital, Yaroslavl, Russia.
5
Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States.
6
RJMMD Consulting, Montreal, QC, Canada.
7
Novartis Pharma AG, Basel, Switzerland.
8
Szegedi Tudomanyegyetem AOK, Gyermekeg. Kozpont, Szeged, Hungary.
9
Somogy Megyei Kaposi Mor Oktato, Korhaz, Kaposvar, Hungary.
10
Kazan State Medical University, Kazan, Russia.
11
Voronezh Burdenko Medical Academy, Voronezh, Russia.
12
Fond.IRCCS Ca' Granda, Osp.Maggiore Policlinico Univ.Studi, Milano, MI, Italy.
13
Hôpital des enfants groupe Pellegrin, Bordeaux, France.
14
Kenezy Gyula Korhaz es, Rendelointezet, Debrecen, Hungary.
15
Clinical Research Center, Alexandria, Egypt.
16
Universitätsklinikum Carl Gustav, Carvus, Dresden, Germany.
17
Hopital Robert Debré, Paris, France.
18
Hospital for Sick Children, Toronto, Ontario, Canada.
19
General Hospital of Thessaloniki, Hippokrateio, Thessaloniki, GR, Greece.

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.

KEYWORDS:

Early eradication; Paediatric patient; Placebo-controlled; Recurrence; Tobramycin inhalation solution

PMID:
29685813
DOI:
10.1016/j.jcf.2018.04.002

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