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Trial record 2 of 86 for:    stop cystic fibrosis

Standardized Treatment of Pulmonary Exacerbations II (STOP2)

This study is currently recruiting participants.
Verified September 2017 by Chris Goss, Seattle Children's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781610
First Posted: May 24, 2016
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Cystic Fibrosis Foundation Therapeutics
CF Therapeutics Development Network Coordinating Center
Medical University of South Carolina
University of Washington
Information provided by (Responsible Party):
Chris Goss, Seattle Children's Hospital
  Purpose

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.


Condition Intervention Phase
Pulmonary Cystic Fibrosis Drug: Standard of care IV antibiotic(s) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Standardized Treatment of Pulmonary Exacerbations II (STOP2)

Resource links provided by NLM:


Further study details as provided by Chris Goss, Seattle Children's Hospital:

Primary Outcome Measures:
  • Absolute change in FEV1 % predicted from Visit 1 to Visit 3 between ERR-10 day and ERR-14 Day [ Time Frame: Start of IV antibiotic treatment to14 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 [ Time Frame: Start of IV antibiotic treatment to14 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 [ Time Frame: Start of IV antibiotic treatment to14 days after the end of IV antibiotic treatment ]
  • Change in CRISS from Visit 1 to Visit 3 between NERR-14 day and NERR-21 day [ Time Frame: Start of IV antibiotic treatment to14 days after the end of IV antibiotic treatment ]
  • Change in weight from Visit 1 to Visit 3 between ERR-10 day and ERR-14 day [ Time Frame: Start of IV antibiotic treatment to14 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 [ Time Frame: Start of IV antibiotic treatment to14 days after the end of IV antibiotic treatment ]

Estimated Enrollment: 880
Study Start Date: June 2016
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ERR-10
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.
Drug: Standard of care IV antibiotic(s)
IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.
ERR-14
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.
Drug: Standard of care IV antibiotic(s)
IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.
NERR-14
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.
Drug: Standard of care IV antibiotic(s)
IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.
NERR-21
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.
Drug: Standard of care IV antibiotic(s)
IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781610


Contacts
Contact: Christian Buhagiar 206-884-1237 christian.buhagiar@seattlechildrens.org

  Hide Study Locations
Locations
United States, Alabama
The Children's Hospital Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Heather Y. Hathorne       hhathorne@peds.uab.edu   
United States, Alaska
Providence Alaska Medical Center Recruiting
Anchorage, Alaska, United States, 99519-6604
Contact: Vicki Roberts       vicki.roberts@providence.org   
United States, Arizona
University Medical Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Osmara Y Molina de Rodriguez       omolina@email.arizona.edu   
United States, California
UC San Diego Medical Center Recruiting
La Jolla, California, United States, 92037
Contact: Katie Kinninger       kkinninger@ucsd.edu   
Lucile S. Packard Children's Hospital Recruiting
Palo Alto, California, United States, 94304
Contact: Colleen Dunn       cedunn@stanford.edu   
University of California Davis, Health System Recruiting
Sacramento, California, United States, 95817
Contact: Kaitlyn Kirk       kkirk@ucdavis.edu   
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Connie St. Clair       StClairC@njhealth.org   
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06106
Contact: Alison Champagne       alison.champagne@hhchealth.org   
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06520
Contact: Jonathan Koff       jonathan.koff@yale.edu   
United States, Florida
Shands Hospital Recruiting
Gainesville, Florida, United States, 32610
Contact: Noni A Graham       Noni.graham@medicine.ufl.edu   
Joe DiMaggio Children's Hospital (Adult) Not yet recruiting
Hollywood, Florida, United States, 33021
Contact: Vivian Bango-Sanchez       vbango-sanchez@mhs.net   
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Eliana J Mendes       emendes@med.miami.edu   
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Eric A Hunter       eahunte@emory.edu   
Augusta University Medical Center Not yet recruiting
Augusta, Georgia, United States, 30912
Contact: Heidi Stapp       hstapp@augusta.edu   
United States, Idaho
St. Luke's Regional Medical Center Recruiting
Boise, Idaho, United States, 83712
Contact: Dixie L Durham       durhamd@slhs.org   
United States, Illinois
Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61603
Contact: Ashley Scott       Ashley.Scott@osfhealthcare.org   
United States, Indiana
Indiana University Hospital, Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lisa Bendy       lbendy@iupui.edu   
United States, Kansas
The University of Kansas Hospital Not yet recruiting
Kansas City, Kansas, United States, 66160
Contact: Adam Schooley       aschooley@kumc.edu   
United States, Maryland
John Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Contact: Britany Zeglin       bzeglin1@jhmi.edu   
United States, Massachusetts
Boston Children's Hospital (BCH) Recruiting
Boston, Massachusetts, United States, 02115
Contact: Robert Fowler       Robert.fowler@childrens.harvard.edu   
University of Massachusetts Memorial Health Care (Worcester, MA) Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Jaclyn Longtine       Jaclyn.Longtine@umassmed.edu   
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109-5212
Contact: Dawn Kruse       dmkruse@med.umich.edu   
Detroit Medical Center; Harper University Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Debra Driscoll       ddriscol@med.wayne.edu   
United States, Missouri
Saint Louis University Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Freda Branch       freda.branch@health.slu.edu   
St. Louis Washington University Adult - Barnes-Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Tina Hicks       Hicks_T@kids.wustl.edu   
United States, Montana
Billings Clinic Recruiting
Billings, Montana, United States, 59107-7000
Contact: Jerimiah Lysinger       JLysinger@billingsclinic.org   
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Barbara A Rodgers       Barbara.A.Rodgers@hitchcock.org   
United States, New Jersey
Monmouth Medical Center Recruiting
Long Branch, New Jersey, United States, 07740
Contact: Bridget Marra       bridget.marra@RWJBH.org   
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Nancy Martinez       nancy.martinez@atlantichealth.org   
Robert Wood Johnson University Hospital (New Brunswick, NJ) Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Deborah A McCloskey       mcclosda@rwjms.rutgers.edu   
United States, New York
Women and Children's Hospital of Buffalo Recruiting
Buffalo, New York, United States, 14222
Contact: Nadine Caci       ncaci@upa.chob.edu   
The Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Kathleen O'Connor       koconnor6@northwell.edu   
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Contact: Anne Kukral       akukral@chpnet.org   
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Emily DiMango       ead3@cumc.columbia.edu   
Highland Hospital; Strong Memorial Hospital Recruiting
Rochester, New York, United States, 14642
Contact: Judy Sroka       judy_sroka@urmc.rochester.edu   
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Donna M Lindner       lindnerd@upstate.edu   
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Meighan Gallagher       Meighan_Gallagher@nymc.edu   
United States, North Carolina
North Carolina Children's Hospital Recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: Rose Cunnion       rcunnion@email.unc.edu   
Wake Forest University Baptist Medical Center Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Bob Hmieleski       bhmieles@wakehealth.edu   
United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44308
Contact: Deborah Ouellette       douellette@chmca.org   
University Hospital of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Heather Tribout       Heather.tribout@UHhospitals.org   
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Lisa Duke       Lisa.Duke@nationwidechildrens.org   
Dayton Children's Hospital Not yet recruiting
Dayton, Ohio, United States, 45404
Contact: Sandy R Bartosik       bartosiks@childrensdayton.org   
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Diane M Kitch       dkitch@psu.edu   
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Victoria Fleck       Victoria.Fleck@uphs.upenn.edu   
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Elizabeth Hartigan       elizabeth.hartigan@chp.edu   
United States, South Carolina
Medical University of South Carolina; Medical University of South Carolina Children's Hospital Recruiting
Charleston, South Carolina, United States, 29425
Contact: Ashley Warden       jonesash@musc.edu   
United States, Texas
Clements University Hospital Recruiting
Dallas, Texas, United States, 75390
Contact: Christopher Tran       Christopher.Tran@UTSouthwestern.edu   
Baylor St. Lukes Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Tracy L Mosely       tmosely@bcm.tmc.edu   
University of Texas Health Center at Tyler Not yet recruiting
Tyler, Texas, United States, 75708-3154
Contact: Debbie Fielder       debbie.fielder@uthct.edu   
United States, Vermont
The University of Vermont Medical Center Inc. Recruiting
Burlington, Vermont, United States, 05401
Contact: Julie Sweet       Julie.Sweet@uvmhealth.org   
United States, Virginia
University of Virginia Health System Not yet recruiting
Charlottesville, Virginia, United States, 22908
Contact: Christie Aderholt       cla6e@virginia.edu   
Medical College of Virginia (Richmond, VA) Recruiting
Richmond, Virginia, United States, 23298
Contact: Ryan Hayden       ryan.hayden@vcuhealth.org   
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Moira Aitken       moira@u.washington.edu   
United States, West Virginia
Ruby Memorial Hospital Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Tammy Clark       tclark@hsc.wvu.edu   
United States, Wisconsin
University of Wisconsin Hospital Center Recruiting
Madison, Wisconsin, United States, 53792
Contact: Chiron (Sophia) Stevens       scstevens@medicine.wisc.edu   
Froedtert Hospital Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Erin Hubertz       ehubertz@mcw.edu   
Canada, Alberta
Calgary Canada Adult CF Clinic Recruiting
Calgary, Alberta, Canada, T2N 4N1
Contact: Michael Parkins, MD    403-220-5951      
Sponsors and Collaborators
Chris Goss
Cystic Fibrosis Foundation Therapeutics
CF Therapeutics Development Network Coordinating Center
Medical University of South Carolina
University of Washington
Investigators
Principal Investigator: Chris Goss, MD University of Washington
Principal Investigator: Patrick Flume, MD Medical University of South Carolina
  More Information

Responsible Party: Chris Goss, Professor of Medicine and Pediatrics, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT02781610     History of Changes
Other Study ID Numbers: STOP2-IP-15
First Submitted: May 12, 2016
First Posted: May 24, 2016
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chris Goss, Seattle Children's Hospital:
Cystic fibrosis
Pulmonary exacerbation
Antibiotic
Treatment duration
Lung infection
Cystic Fibrosis Foundation
Cystic Fibrosis Foundation National Patient Registry

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents