Cystic Fibrosis Exacerbation Treatment with IV Antibiotics: The STOP2 Study – Phase IV

Protocol Description

The purpose of this multi-center collaborative research study is to help determine the length of time that a person with cystic fibrosis should be given antibiotics intravenously (via IV) for treatment of pulmonary exacerbations. A pulmonary exacerbation is a worsening of respiratory symptoms. Doctors and patients want to make sure the patient gets antibiotics long enough to get better without treating too long and exposing the patient to unnecessary risks.

Study Level: Phase IV

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to participants of both genders, ages 18 and older, who have cystic fibrosis and are going to be put onto IV antibiotics for a pulmonary exacerbation.
Males and females: Ages 18 and older

Requirements

In this study, participants will be given standard-of-care IV antibiotics. For patients who meet criteria for early robust response within the first week of treatment, IV antibiotics will be provided for a total of either 10 or 14 days, determined by randomization. For patients who do not meet the criteria for early robust response to treatment, IV antibiotics will be provided for a total of either 14 or 21 days, again determined by randomization. Physical exams, tests and blood and sputum samples will be collected at certain intervals.
Visits: 34
Duration: 24 to 35 days

Status: Open to Enrollment

Source(s) of Support

Medical University of South Carolina
Cystic Fibrosis Foundation Therapeutics
CF Therapeutics Development Network Coordinating Center
University of Washington

Additional Information

Study Description at National Institutes of Health
Cystic Fibrosis
Pulmonary Medicine Research

Primary Investigator

Joseph Pilewski, MD

Contact Information

For more information about the study or enrollment, please contact:
Clinical Research Nurse Coordinator
Rose Lanzo BS, RRT, CRC
412-692-5872