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Standardized Treatment of Pulmonary Exacerbations II (STOP2)

Primary Purpose

Pulmonary Cystic Fibrosis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Standard of care IV antibiotic(s)
Sponsored by
Chris Goss
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Cystic Fibrosis focused on measuring Cystic fibrosis, Pulmonary exacerbation, Antibiotic, Treatment duration, Lung infection, Cystic Fibrosis Foundation, Cystic Fibrosis Foundation National Patient Registry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • The Children's Hospital Alabama
  • Providence Alaska Medical Center
  • University Medical Center
  • UC San Diego Medical Center
  • Lucile S. Packard Children's Hospital
  • University of California Davis, Health System
  • National Jewish Health
  • Hartford Hospital
  • Yale New Haven Hospital
  • Shands Hospital
  • Joe DiMaggio Children's Hospital (Adult)
  • University of Miami
  • Emory University Hospital
  • Augusta University Medical Center
  • St. Luke's Regional Medical Center
  • Saint Francis Medical Center
  • Indiana University Hospital, Indiana University Health
  • The University of Kansas Hospital
  • John Hopkins Hospital
  • Boston Children's Hospital (BCH)
  • University of Massachusetts Memorial Health Care (Worcester, MA)
  • University of Michigan Health System
  • Detroit Medical Center; Harper University Hospital
  • Saint Louis University Hospital
  • St. Louis Washington University Adult - Barnes-Jewish Hospital
  • Billings Clinic
  • Dartmouth Hitchcock Medical Center
  • Monmouth Medical Center
  • Morristown Medical Center
  • Robert Wood Johnson University Hospital (New Brunswick, NJ)
  • Women and Children's Hospital of Buffalo
  • The Long Island Jewish Medical Center
  • Beth Israel Medical Center
  • Columbia University Medical Center
  • Highland Hospital; Strong Memorial Hospital
  • SUNY Upstate Medical University Hospital
  • New York Medical College
  • North Carolina Children's Hospital
  • Wake Forest University Baptist Medical Center
  • Akron Children's Hospital
  • University Hospital of Cleveland
  • Nationwide Children's Hospital
  • Dayton Children's Hospital
  • Penn State Milton S. Hershey Medical Center
  • Hospital of the University of Pennsylvania
  • Children's Hospital of Pittsburgh of UPMC
  • Medical University of South Carolina; Medical University of South Carolina Children's Hospital
  • University of Texas Southwestern
  • Baylor St. Lukes Medical Center
  • University of Texas Health Center at Tyler
  • The University of Vermont Medical Center Inc.
  • University of Virginia Health System
  • Medical College of Virginia (Richmond, VA)
  • University of Washington Medical Center
  • Ruby Memorial Hospital
  • University of Wisconsin Hospital Center
  • Froedtert Hospital
  • Calgary Canada Adult CF Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

ERR-10

ERR-14

NERR-14

NERR-21

Arm Description

ERR treatment duration - 10 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.

ERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.

NERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.

NERR treatment duration - 21 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.

Outcomes

Primary Outcome Measures

Absolute Change in FEV1 % Predicted From Visit 1 to Visit 3 Between ERR-10 Day and ERR-14 Day
Absolute change in FEV1 % predicted from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment).
Absolute Change in FEV1 % Predicted From Visit 1 to Visit 3 Between NERR-14 Day and NERR-21
Absolute change in FEV1 % predicted from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment).

Secondary Outcome Measures

Change in CRISS From Visit 1 to Visit 3 Between ERR-10 Day and ERR-14 Day
Absolute change in respiratory symptoms, as measured by the the Cystic Fibrosis Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CFRSD-CRISS), from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment). The Diary asks a participant to state the extent of their 8 respiratory symptoms: difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present 'a great deal' or 'extremely'. A summed score (range from 0-24) is calculated for each participant and converted to a final score with a range of 0 to 100, where the lowest scores indicate improvement of symptoms.
Change in CRISS From Visit 1 to Visit 3 Between NERR-14 Day and NERR-21 Day
Absolute change in respiratory symptoms, as measured by the the Cystic Fibrosis Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CFRSD-CRISS), from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment). The Diary asks a participant to state the extent of their 8 respiratory symptoms: difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present 'a great deal' or 'extremely'. A summed score (range from 0-24) is calculated for each participant and converted to a final score with a range of 0 to 100, where the lowest scores indicate improvement of symptoms.
Change in Weight From Visit 1 to Visit 3 Between ERR-10 Day and ERR-14 Day
Absolute change in weight (kg) from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment).
Change in Weight From Visit 1 to Visit 3 Between NERR-14 Day and NERR-21 Day
Absolute change in weight (kg) from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment).

Full Information

First Posted
May 12, 2016
Last Updated
April 28, 2021
Sponsor
Chris Goss
Collaborators
Cystic Fibrosis Foundation, CF Therapeutics Development Network Coordinating Center, Medical University of South Carolina, University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT02781610
Brief Title
Standardized Treatment of Pulmonary Exacerbations II
Acronym
STOP2
Official Title
Standardized Treatment of Pulmonary Exacerbations II (STOP2)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
March 6, 2020 (Actual)
Study Completion Date
March 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chris Goss
Collaborators
Cystic Fibrosis Foundation, CF Therapeutics Development Network Coordinating Center, Medical University of South Carolina, University of Washington

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
The study will assess the non-inferiority of 10 days versus 14 days treatment duration among patients who have an early robust improvement (ERR subjects) and the superiority of 21 days versus 14 days treatment duration among the subjects who do not meet the definition of ERR (non-ERR; NERR). Subjects will undergo pulmonary function testing (spirometry) and complete a respiratory symptom score [Chronic Respiratory Infection Symptom Score (CRISS)] at initiation of IV treatment (Baseline/ Visit 1) and at Day 7-10 (Visit 2). At Visit 2, subjects will be allocated to groups ERR or NERR based on their initial clinical response as determined by the change in forced expiratory volume in 1 second (FEV1; percent of predicted) and CRISS from Baseline and then randomized to an IV treatment duration (nested within group). ERR subjects [≥8% predicted improvement in FEV1 from Visit 1 to Visit 2 and CRISS reduction of ≥11 points from Visit 1 to Visit 2] will be randomized 1:1 to either 10 days or 14 days total IV antibiotic treatment duration. Remaining (NERR) subjects will be randomized 1:1 to receive either 14 or 21 days total IV antibiotic treatment duration. All subjects will be evaluated again at Visit 3, 14 days following scheduled completion of IV antibiotic treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Cystic Fibrosis
Keywords
Cystic fibrosis, Pulmonary exacerbation, Antibiotic, Treatment duration, Lung infection, Cystic Fibrosis Foundation, Cystic Fibrosis Foundation National Patient Registry

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
982 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ERR-10
Arm Type
Other
Arm Description
ERR treatment duration - 10 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.
Arm Title
ERR-14
Arm Type
Other
Arm Description
ERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.
Arm Title
NERR-14
Arm Type
Other
Arm Description
NERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.
Arm Title
NERR-21
Arm Type
Other
Arm Description
NERR treatment duration - 21 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.
Intervention Type
Drug
Intervention Name(s)
Standard of care IV antibiotic(s)
Intervention Description
IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.
Primary Outcome Measure Information:
Title
Absolute Change in FEV1 % Predicted From Visit 1 to Visit 3 Between ERR-10 Day and ERR-14 Day
Description
Absolute change in FEV1 % predicted from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment).
Time Frame
Start of IV antibiotic treatment to 14 days after the end of IV antibiotic treatment
Title
Absolute Change in FEV1 % Predicted From Visit 1 to Visit 3 Between NERR-14 Day and NERR-21
Description
Absolute change in FEV1 % predicted from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment).
Time Frame
Start of IV antibiotic treatment to14 days after the end of IV antibiotic treatment
Secondary Outcome Measure Information:
Title
Change in CRISS From Visit 1 to Visit 3 Between ERR-10 Day and ERR-14 Day
Description
Absolute change in respiratory symptoms, as measured by the the Cystic Fibrosis Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CFRSD-CRISS), from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment). The Diary asks a participant to state the extent of their 8 respiratory symptoms: difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present 'a great deal' or 'extremely'. A summed score (range from 0-24) is calculated for each participant and converted to a final score with a range of 0 to 100, where the lowest scores indicate improvement of symptoms.
Time Frame
Start of IV antibiotic treatment to14 days after the end of IV antibiotic treatment
Title
Change in CRISS From Visit 1 to Visit 3 Between NERR-14 Day and NERR-21 Day
Description
Absolute change in respiratory symptoms, as measured by the the Cystic Fibrosis Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CFRSD-CRISS), from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment). The Diary asks a participant to state the extent of their 8 respiratory symptoms: difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present 'a great deal' or 'extremely'. A summed score (range from 0-24) is calculated for each participant and converted to a final score with a range of 0 to 100, where the lowest scores indicate improvement of symptoms.
Time Frame
Start of IV antibiotic treatment to14 days after the end of IV antibiotic treatment
Title
Change in Weight From Visit 1 to Visit 3 Between ERR-10 Day and ERR-14 Day
Description
Absolute change in weight (kg) from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment).
Time Frame
Start of IV antibiotic treatment to14 days after the end of IV antibiotic treatment
Title
Change in Weight From Visit 1 to Visit 3 Between NERR-14 Day and NERR-21 Day
Description
Absolute change in weight (kg) from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment).
Time Frame
Start of IV antibiotic treatment to14 days after the end of IV antibiotic treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Goss, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick Flume, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99519-6604
Country
United States
Facility Name
University Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
UC San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Lucile S. Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of California Davis, Health System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Joe DiMaggio Children's Hospital (Adult)
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Augusta University Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
St. Luke's Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Indiana University Hospital, Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
The University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
John Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Boston Children's Hospital (BCH)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Massachusetts Memorial Health Care (Worcester, MA)
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5212
Country
United States
Facility Name
Detroit Medical Center; Harper University Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Saint Louis University Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Louis Washington University Adult - Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Robert Wood Johnson University Hospital (New Brunswick, NJ)
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Women and Children's Hospital of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
Facility Name
The Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Highland Hospital; Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
North Carolina Children's Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
University Hospital of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Dayton Children's Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Medical University of South Carolina; Medical University of South Carolina Children's Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor St. Lukes Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708-3154
Country
United States
Facility Name
The University of Vermont Medical Center Inc.
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Medical College of Virginia (Richmond, VA)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Ruby Memorial Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
University of Wisconsin Hospital Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Calgary Canada Adult CF Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35300932
Citation
Gold LS, Hansen RN, Patrick DL, Tabah A, Heltshe SL, Flume PA, Goss CH, West NE, Sanders DB, VanDevanter DR, Kessler L. Health care costs in a randomized trial of antimicrobial duration among cystic fibrosis patients with pulmonary exacerbations. J Cyst Fibros. 2022 Jul;21(4):594-599. doi: 10.1016/j.jcf.2022.03.001. Epub 2022 Mar 14.
Results Reference
derived
PubMed Identifier
34933824
Citation
VanDevanter DR, Heltshe SL, Skalland M, West NE, Sanders DB, Goss CH, Flume PA. C-reactive protein (CRP) as a biomarker of pulmonary exacerbation presentation and treatment response. J Cyst Fibros. 2022 Jul;21(4):588-593. doi: 10.1016/j.jcf.2021.12.003. Epub 2021 Dec 18.
Results Reference
derived
PubMed Identifier
34469706
Citation
Goss CH, Heltshe SL, West NE, Skalland M, Sanders DB, Jain R, Barto TL, Fogarty B, Marshall BC, VanDevanter DR, Flume PA; STOP2 Investigators. A Randomized Clinical Trial of Antimicrobial Duration for Cystic Fibrosis Pulmonary Exacerbation Treatment. Am J Respir Crit Care Med. 2021 Dec 1;204(11):1295-1305. doi: 10.1164/rccm.202102-0461OC.
Results Reference
derived
PubMed Identifier
34159577
Citation
Holland P, Jahnke N. Single versus combination intravenous anti-pseudomonal antibiotic therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2021 Jun 23;6(6):CD002007. doi: 10.1002/14651858.CD002007.pub5.
Results Reference
derived

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Standardized Treatment of Pulmonary Exacerbations II

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