Standardized Treatment of Pulmonary Exacerbations II

Completed · Phase 4

Conditions studied: Pulmonary Cystic Fibrosis

In brief

Cystic fibrosis (CF), a life-shortening genetic disease, is marked by acute episodes during which symptoms of lung infection increase and lung function decreases. These pulmonary exacerbations are treated with varying antibiotics for varying time periods based on needs determined by individual patients, their families, and the health care providers. Cystic fibrosis pulmonary guidelines for the treatment of pulmonary exacerbation published by the Cystic Fibrosis Foundation (CFF) in 2009 provided recommendations for treatment and also identified key questions for which additional studies were needed. A strong desire among clinicians to reduce treatment durations (and reduce cost, inconvenience, and potential toxicities) is in conflict with belief that patients not responding robustly to treatment might benefit from extending treatment. This randomized, controlled, open-label study is designed to evaluate the efficacy and safety of differing durations of IV treatment, given in the hospital or at home for a pulmonary exacerbation in adult patients with CF.

Key facts

Study ID

NCT02781610

Run by

Chris Goss

People needed

982

Starts

2016-06-01

Expected to finish

2020-03-06

Last updated by the study team

2021-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Key Inclusion Criteria:
• Male or female ≥18 years of age at Visit 1
• Documentation of a CF diagnosis
• Enrolled in the Cystic Fibrosis Foundation National Patient Registry (CFFNPR) prior to Visit 1 (US sites only)
• At the time of Visit 1, there is a plan to initiate IV antibiotics for a pulmonary exacerbation
• Performed spirometry at Visit 1 and Visit 2 and willing to perform spirometry at Visit 3
• Completed the CRISS questionnaire at Visit 1 and Visit 2 and willing to complete the Cystic Fibrosis Respiratory Symptoms Diary (CFRSD) questionnaire at Visit 3
• Willing to adhere to a specific treatment duration determined by initial response to treatment and subsequent randomization
• Willing to return for follow up Visit 3
• Written informed consent obtained from the subject or subject's legal representative

You may not qualify if…

• Key Exclusion Criteria
• Previous randomization 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 in the two weeks prior to Visit 2, unless admission was due to a desensitization protocol
• Pneumothorax in the two weeks prior to Visit 2
• Primary diagnosis for current hospitalization is unrelated to worsening lower respiratory symptoms (e.g., pulmonary clean out, distal intestinal obstruction syndrome (DIOS), sinusitis)
• Massive hemoptysis defined as > 250 cc in a 24 hour period or 100 cc/day over 4 consecutive days occurring in the two weeks prior to Visit 2
• Current pulmonary exacerbation thought to be due to allergic bronchopulmonary aspergillosis (ABPA)
• At Visit 1, receiving ongoing treatment with a duration of more than 2 weeks with prednisone equivalent to >10mg/day
• History of solid organ transplantation
• Receiving antimicrobial therapy to treat non-tuberculous mycobacterium (e.g., M. abscessus, M. avium complex) in the two weeks prior to Visit 2

Where it is running

• Providence Alaska Medical Center — Anchorage, Alaska, United States
• University Medical Center — Tucson, Arizona, United States
• UC San Diego Medical Center — La Jolla, California, United States
• Lucile S. Packard Children's Hospital — Palo Alto, California, United States
• University of California Davis, Health System — Sacramento, California, United States
• National Jewish Health — Denver, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Shands Hospital — Gainesville, Florida, United States
• Joe DiMaggio Children's Hospital (Adult) — Hollywood, Florida, United States
• University of Miami — Miami, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Augusta University Medical Center — Augusta, Georgia, United States
• St. Luke's Regional Medical Center — Boise, Idaho, United States
• Saint Francis Medical Center — Peoria, Illinois, United States
• Indiana University Hospital, Indiana University Health — Indianapolis, Indiana, United States
• The University of Kansas Hospital — Kansas City, Kansas, United States
• John Hopkins Hospital — Baltimore, Maryland, United States
• Boston Children's Hospital (BCH) — Boston, Massachusetts, United States
• University of Massachusetts Memorial Health Care (Worcester, MA) — Worcester, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Detroit Medical Center; Harper University Hospital — Detroit, Michigan, United States
• Saint Louis University Hospital — St Louis, Missouri, United States
• St. Louis Washington University Adult - Barnes-Jewish Hospital — St Louis, Missouri, United States
• The Children's Hospital Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.