Pilot Observational Study to Determine Feasibility of a Standardized Treatment of Pulmonary Exacerb. in Patients With CF

Completed

Conditions studied: Cystic Fibrosis, Lung Infection, Cystic Fibrosis Pulmonary Exacerbation

In brief

The goal of this research study is to better understand current treatment practices for pulmonary exacerbations (lung infections) and whether the Cystic Fibrosis National Patient Registry (CFFNPR)can be used for this type of study.

Key facts

Study ID

NCT02109822

Run by

University of Washington

People needed

220

Starts

2014-01-01

Expected to finish

2015-06-01

Last updated by the study team

2016-10-26

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ≥12 years of age at Visit 1
• Enrolled in the CFFNPR (Patients may enroll in the Registry at Visit 1 if not previously enrolled.)
• Current hospitalization for treatment of a pulmonary exacerbation
• Planned hospital admission of at least 5 days with intravenous (IV) antibiotics at Visit 1
• Able to perform spirometry at admission and willing to perform spirometry on subsequent treatment and visit days
• Willing and able to complete symptom score daily
• Willing to return for a follow up visit at end of treatment (if necessary) and 28 days after start of IV antibiotic therapy
• Written informed consent (and assent when applicable) obtained from the participant or participant's legal representative

You may not qualify if…

• Previous enrollment in this study
• Treatment with IV antibiotics in the 6 weeks prior to Visit 1
• Admission to the intensive care unit for current pulmonary exacerbation
• Pneumothorax on admission
• Current hospitalization for scheduled pulmonary clean out
• Current hospitalization for sinusitis as the primary diagnosis
• Massive hemoptysis defined as > 250 cc in a 24 hour period, or 100 cc/day over 4 consecutive days occurring within one week of Visit 1
• Current pulmonary exacerbation thought to be due to allergic bronchopulmonary aspergillosis (ABPA)
• Ongoing treatment with prednisone equivalent >10 mg/day for greater than 2 weeks initiated prior to Visit 1
• History of solid organ transplantation Currently receiving antimicrobial therapy to treat non-tuberculous mycobacterium (e.g., M. abscessus, M. avium complex)

Where it is running

• CFF Adult Program University of Alabama — Birmingham, Alabama, United States
• CFF Care Center Arizona Health Science Center — Tucson, Arizona, United States
• National Jewish Health — Denver, Colorado, United States
• Johns Hopkins — Baltimore, Maryland, United States
• CFF Care Center & Pediatric Program Rainbow Babies and Children's Hospita — Cleveland, Ohio, United States
• Rainbow Babies and Children's Hospital & University Hospitals Case Medical Center — Cleveland, Ohio, United States
• CFF Care Center & Pediatric Program Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• CFF Care Center & Pediatric Program The University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• CFF Care Center & Pediatric Program Seattle Children's Hospital — Seattle, Washington, United States
• University of Washington — Seattle, Washington, United States
• CFF Care Center & Pediatric Program University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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