Pilot Observational Study to Determine Feasibility of a Standardized Treatment of Pulmonary Exacerb. in Patients With CF
STOP-OB-13
1 other identifier
observational
220
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2014
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 6, 2014
CompletedFirst Posted
Study publicly available on registry
April 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedOctober 26, 2016
October 1, 2016
1.4 years
March 6, 2014
October 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (1)
Physician and patient level clinical outcomes for their use in comparative studies of CF pulmonary exacerbations to determine the optimal treatment endpoints
During hospitalization and during a period following discharge of 28 days from time of start of IV antibiotic therapy.
Other Outcomes (2)
Variability of practicing clinicians' treatment objectives, approaches, and assessment of outcomes related to CF pulmonary exacerbation
during hospitalization and during a period following discharge of 28 days from time of start of IV antibiotic therapy.
Inform the design of future pragmatic research of CF pulmonary exacerbation
During hospitalization and during a period following discharge of 28 days from time of start of IV antibiotic therapy.
Study Arms (1)
CF patients with pulmonary exacerbations
Patients with CF who are hospitalized with a pulmonary exacerbation treated with intravenous antibiotics.
Eligibility Criteria
Patients with Cystic Fibrosis who are hospitalized with a pulmonary exacerbation treated with intravenous antibiotics.
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- Medical University of South Carolinacollaborator
- Cystic Fibrosis Foundationcollaborator
Study Sites (12)
CFF Adult Program University of Alabama
Birmingham, Alabama, 35233, United States
CFF Care Center Arizona Health Science Center
Tucson, Arizona, 85721, United States
National Jewish Health
Denver, Colorado, 80206, United States
Johns Hopkins
Baltimore, Maryland, 21205, United States
CFF Care Center & Pediatric Program Rainbow Babies and Children's Hospita
Cleveland, Ohio, 44106, United States
Rainbow Babies and Children's Hospital & University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
CFF Care Center & Pediatric Program Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
CFF Care Center & Pediatric Program The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235, United States
CFF Care Center & Pediatric Program Seattle Children's Hospital
Seattle, Washington, 98105, United States
University of Washington
Seattle, Washington, 98195, United States
CFF Care Center & Pediatric Program University of Wisconsin
Madison, Wisconsin, 53706, United States
Related Publications (2)
VanDevanter DR, Heltshe SL, Sanders DB, West NE, Skalland M, Flume PA, Goss CH; STOP-OB Study. Changes in symptom scores as a potential clinical endpoint for studies of cystic fibrosis pulmonary exacerbation treatment. J Cyst Fibros. 2021 Jan;20(1):36-38. doi: 10.1016/j.jcf.2020.08.006. Epub 2020 Aug 13.
PMID: 32800708DERIVEDStuart Elborn J, Geller DE, Conrad D, Aaron SD, Smyth AR, Fischer R, Kerem E, Bell SC, Loutit JS, Dudley MN, Morgan EE, VanDevanter DR, Flume PA. A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients. J Cyst Fibros. 2015 Jul;14(4):507-14. doi: 10.1016/j.jcf.2014.12.013. Epub 2015 Jan 13.
PMID: 25592656DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher H. Goss, MD MSc
University of Washington
- PRINCIPAL INVESTIGATOR
Patrick Flume, MD
Medical University of South Carolina
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
March 6, 2014
First Posted
April 10, 2014
Study Start
January 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
October 26, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Data will be available once the primary manuscripts are published. Data without identifiers will be available through the Cystic Fibrosis Therapeutics Development Network Coordinating Center once an application to use the data is approved.