Cystic Fibrosis Clinical Trial
— STOP-OB-13Official title:
Pilot Observational Study to Determine Feasibility of a Standardized Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis
Verified date | October 2016 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 220 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins | Baltimore | Maryland |
United States | CFF Adult Program University of Alabama | Birmingham | Alabama |
United States | Medical University of South Carolina | Charleston | South Carolina |
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 The University of Texas Southwestern Medical Center at Dallas | Dallas | Texas |
United States | National Jewish Health | Denver | Colorado |
United States | CFF Care Center & Pediatric Program University of Wisconsin | Madison | Wisconsin |
United States | CFF Care Center & Pediatric Program Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
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 Arizona Health Science Center | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Cystic Fibrosis Foundation Therapeutics, Medical University of South Carolina |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Variability of practicing clinicians' treatment objectives, approaches, and assessment of outcomes related to CF pulmonary exacerbation | Describe the variability of practicing clinicians' treatment objectives as measured by the physician assessment questionnaire, treatment approaches as measured by the choices of medications (specifically antibiotics), and assessment of patient level outcomes related to CF pulmonary exacerbation (change in lung function as measured by spirometry, respiratory symptoms as measure by the CFRSD-CRISS questionnaire) and health related quality of life (as measured by the EQ-5D questionnaire). | during hospitalization and during a period following discharge of 28 days from time of start of IV antibiotic therapy. | No |
Other | Inform the design of future pragmatic research of CF pulmonary exacerbation | Identify the appropriate target patient population for future clinical trials by clarifying required stratification factors, and estimating target treatment effects and variability of treatment response. | During hospitalization and during a period following discharge of 28 days from time of start of IV antibiotic therapy. | No |
Primary | Feasibility of using the CFF National Patient Registry | Assess feasibility using the CFF National Patient Registry as measured by the accuracy of data entry | 28 days from time of start of IV antibiotic therapy. | No |
Secondary | Physician and patient level clinical outcomes for their use in comparative studies of CF pulmonary exacerbations to determine the optimal treatment endpoints | Evaluate physician assessment of treatment response as measured by the physician treatment assessment questionnaire. Evaluate change in lung function and patient reported respiratory symptoms and quality of life in response to treatment of an acute pulmonary exacerbation. | During hospitalization and during a period following discharge of 28 days from time of start of IV antibiotic therapy. | No |
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