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J Cyst Fibros. 2017 Sep;16(5):592-599. doi: 10.1016/j.jcf.2017.04.005. Epub 2017 Apr 29.

Standardized Treatment of Pulmonary Exacerbations (STOP) study: Observations at the initiation of intravenous antibiotics for cystic fibrosis pulmonary exacerbations.

Author information

1
Department of Pediatrics, University of Wisconsin-Madison, Madison, WI, USA. Electronic address: dbsand@iu.edu.
2
Department of Medicine, Gregory Fleming James Cystic Fibrosis Center, University of Alabama at Birmingham, Birmingham, AL, USA.
3
Cystic Fibrosis Foundation Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, WA, USA.
4
Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.
5
Department of Pediatrics, University of Arizona, Tucson, AZ, USA.
6
Cystic Fibrosis Foundation Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, WA, USA; Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, USA.
7
Department of Pediatrics, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
8
Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
9
Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, USA.
10
Department of Medicine, National Jewish Health, Denver, CO, USA.
11
Cystic Fibrosis Foundation, Bethesda, MD, USA.
12
Departments of Medicine and Pediatrics, Medical University of South Carolina, Charleston, SC, USA.
13
Cystic Fibrosis Foundation Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, WA, USA; Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, USA; Department of Medicine, University of Washington, Seattle, WA, USA.

Abstract

BACKGROUND:

The Standardized Treatment of Pulmonary Exacerbations (STOP) program has the intent of defining best practices in the treatment of pulmonary exacerbations (PEx) in patients with cystic fibrosis (CF). The objective of this analysis was to describe the clinical presentations of patients admitted for intravenous (IV) antibiotics and enrolled in a prospective observational PEx study as well as to understand physician treatment goals at the start of the intervention.

METHODS:

We enrolled adolescents and adults admitted to the hospital for a PEx treated with IV antibiotics. We recorded patient and PEx characteristics at the time of enrollment. We surveyed treating physicians on treatment goals as well as their willingness to enroll patients in various study designs. Additional demographic and clinical data were obtained from the CF Foundation Patient Registry.

RESULTS:

Of 220 patients enrolled, 56% were female, 19% were adolescents, and 71% were infected with P. aeruginosa. The mean (SD) FEV1 at enrollment was 51.1 (21.6)% predicted. Most patients (85%) experienced symptoms for ≥7days before admission, 43% had received IV antibiotics within the previous 6months, and 48% received oral and/or inhaled antibiotics prior to IV antibiotic initiation. Forty percent had ≥10% FEV1 decrease from their best value recorded in the previous 6months, but for 20% of patients, their enrollment FEV1 was their best FEV1 recorded within the previous 6months. Physicians reported that their primary treatment objectives were lung function recovery (53%) and improvement of symptoms (47%) of PEx. Most physicians stated they would enroll patients in studies involving 10-day (72%) or 14-day (87%), but not 7-day (29%), treatment regimens.

CONCLUSIONS:

Based on the results of this study, prospective studies are feasible and physician willingness for interventional studies of PEx exists. Results of this observational study will help design future PEx trials.

KEYWORDS:

FEV(1); Pseudomonas aeruginosa; Symptoms

PMID:
28460885
PMCID:
PMC5582015
DOI:
10.1016/j.jcf.2017.04.005
[Indexed for MEDLINE]
Free PMC Article

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