Pulmonary Cystic FibrosisPhase 4STOP2NCT02781610
Standardized Treatment of Pulmonary Exacerbations II
A Phase 4 study of Pulmonary Cystic Fibrosis, run by Chris Goss at 58 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Cystic Fibrosis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 982 participants
- Where
- 58 sitesin 2 countries
- Study dates
- Jun 2016to 6 Mar 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
58 sites in 2 countries.
58 sites in 2 countries
United States57 sites
Akron Children's Hospital
Akron, Ohio, 44308
Providence Alaska Medical Center
Anchorage, Alaska, 99519-6604
University of Michigan Health System
Ann Arbor, Michigan, 48109-5212
Emory University Hospital
Atlanta, Georgia, 30322
Augusta University Medical Center
Augusta, Georgia, 30912
John Hopkins Hospital
Baltimore, Maryland, 21205
Billings Clinic
Billings, Montana, 59107-7000
The Children's Hospital Alabama
Birmingham, Alabama, 35233
St. Luke's Regional Medical Center
Boise, Idaho, 83712
Boston Children's Hospital (BCH)
Boston, Massachusetts, 02115
Women and Children's Hospital of Buffalo
Buffalo, New York, 14222
The University of Vermont Medical Center Inc.
Burlington, Vermont, 05401
North Carolina Children's Hospital
Chapel Hill, North Carolina, 27517
Medical University of South Carolina; Medical University of South Carolina Children's Hospital
Charleston, South Carolina, 29425
University of Virginia Health System
Charlottesville, Virginia, 22908
University Hospital of Cleveland
Cleveland, Ohio, 44106
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwestern
Dallas, Texas, 75390
Dayton Children's Hospital
Dayton, Ohio, 45404
National Jewish Health
Denver, Colorado, 80206
Detroit Medical Center; Harper University Hospital
Detroit, Michigan, 48201
Shands Hospital
Gainesville, Florida, 32610
Hartford Hospital
Hartford, Connecticut, 06106
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Joe DiMaggio Children's Hospital (Adult)
Hollywood, Florida, 33021
Baylor St. Lukes Medical Center
Houston, Texas, 77030
Indiana University Hospital, Indiana University Health
Indianapolis, Indiana, 46202
The University of Kansas Hospital
Kansas City, Kansas, 66160
UC San Diego Medical Center
La Jolla, California, 92037
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Monmouth Medical Center
Long Branch, New Jersey, 07740
University of Wisconsin Hospital Center
Madison, Wisconsin, 53792
University of Miami
Miami, Florida, 33136
Froedtert Hospital
Milwaukee, Wisconsin, 53226
Ruby Memorial Hospital
Morgantown, West Virginia, 26506
Morristown Medical Center
Morristown, New Jersey, 07960
Robert Wood Johnson University Hospital (New Brunswick, NJ)
New Brunswick, New Jersey, 08903
Yale New Haven Hospital
New Haven, Connecticut, 06520
The Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Beth Israel Medical Center
New York, New York, 10003
Columbia University Medical Center
New York, New York, 10032
Lucile S. Packard Children's Hospital
Palo Alto, California, 94304
Saint Francis Medical Center
Peoria, Illinois, 61603
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Medical College of Virginia (Richmond, VA)
Richmond, Virginia, 23298
Highland Hospital; Strong Memorial Hospital
Rochester, New York, 14642
University of California Davis, Health System
Sacramento, California, 95817
University of Washington Medical Center
Seattle, Washington, 98195
Saint Louis University Hospital
St Louis, Missouri, 63110
St. Louis Washington University Adult - Barnes-Jewish Hospital
St Louis, Missouri, 63110
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
University Medical Center
Tucson, Arizona, 85724
University of Texas Health Center at Tyler
Tyler, Texas, 75708-3154
New York Medical College
Valhalla, New York, 10595
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
University of Massachusetts Memorial Health Care (Worcester, MA)
Worcester, Massachusetts, 01655
About this study
Official title: Standardized Treatment of Pulmonary Exacerbations II (STOP2)
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.
Read the 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.
- Conditions
- Pulmonary Cystic Fibrosis
- Being tested
- Standard of care IV antibiotic(s)
- Keywords
- Cystic fibrosis, Pulmonary exacerbation, Antibiotic, Treatment duration, Lung infection, Cystic Fibrosis Foundation, Cystic Fibrosis Foundation National Patient Registry
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care IV antibiotic(s)Drug
IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.
| Study group | Role | What they receive |
|---|---|---|
| ERR-10 | Other | 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. Receives: Drug: Standard of care IV antibiotic(s) |
| ERR-14 | Other | 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. Receives: Drug: Standard of care IV antibiotic(s) |
| NERR-14 | Other | 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. Receives: Drug: Standard of care IV antibiotic(s) |
| NERR-21 | Other | 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. Receives: Drug: Standard of care IV antibiotic(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Start of IV antibiotic treatment to 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).
Measured: Start of IV antibiotic treatment to14 days after the end of IV antibiotic treatment
Secondary outcomes (4)
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
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).
Measured: Start of IV antibiotic treatment to14 days after the end of IV antibiotic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startJun 2016
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 982 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chris Goss
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, CF Therapeutics Development Network Coordinating Center, Medical University of South Carolina, University of Washington
- Responsible party
- Sponsor-investigator, Chris Goss, Seattle Children's Hospital
- Investigators
- Chris Goss, MD, Principal investigator, University of WashingtonPatrick Flume, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781610
- Sponsor's protocol ID
- STOP2-IP-15
- Acronym
- STOP2
- Status last verified
- Apr 2021
- First submitted
- 12 May 2016
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
McElvaney OJ, Heltshe SL, Odem-Davis K, West NE, Sanders DB, Fogarty B, VanDevanter DR, Flume PA, Goss CH. Adjunctive Systemic Corticosteroids for Pulmonary Exacerbations of Cystic Fibrosis. Ann Am Thorac Soc. 2024 May;21(5):716-726. doi: 10.1513/AnnalsATS.202308-673OC.
PubMed 38096105Thornton CS, Caverly LJ, Kalikin LM, Carmody LA, McClellan S, LeBar W, Sanders DB, West NE, Goss CH, Flume PA, Heltshe SL, VanDevanter DR, LiPuma JJ. Prevalence and Clinical Impact of Respiratory Viral Infections from the STOP2 Study of Cystic Fibrosis Pulmonary Exacerbations. Ann Am Thorac Soc. 2024 Apr;21(4):595-603. doi: 10.1513/AnnalsATS.202306-576OC.
PubMed 37963297Gold 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.
PubMed 35300932VanDevanter 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.
PubMed 34933824Goss 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.
PubMed 34469706Holland 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.
PubMed 34159577
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Treatment of Pulmonary Exacerbations II (STOP2)
- ClinicalTrials.gov ID
- NCT02781610
- Acronym / sponsor ID
- STOP2 / STOP2-IP-15
- Conditions
- Pulmonary Cystic Fibrosis
- Keywords
- Cystic fibrosis, Pulmonary exacerbation, Antibiotic, Treatment duration, Lung infection, Cystic Fibrosis Foundation, Cystic Fibrosis Foundation National Patient Registry
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 982 participants (actual)
- Lead sponsor
- Chris GossUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, CF Therapeutics Development Network Coordinating Center, Medical University of South Carolina, University of Washington
- Study start
- Jun 2016
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 24 May 2016 (estimated)
- Results
- Posted 8 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ERR-10 | Other | Drug: Standard of care IV antibiotic(s)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-14 | Other | Drug: Standard of care IV antibiotic(s)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-14 | Other | Drug: Standard of care IV antibiotic(s)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-21 | Other | Drug: Standard of care IV antibiotic(s)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | ERR-10, ERR-14, NERR-14, NERR-21 |
Primary outcome
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 to 14 days after the end of IV antibiotic treatment
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
Time frame: Start of IV antibiotic treatment to14 days after the end of IV antibiotic treatment
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).
4 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38096105McElvaney OJ, Heltshe SL, Odem-Davis K, West NE, Sanders DB, Fogarty B, VanDevanter DR, Flume PA, Goss CH. Adjunctive Systemic Corticosteroids for Pulmonary Exacerbations of Cystic Fibrosis. Ann Am Thorac Soc. 2024 May;21(5):716-726. doi: 10.1513/AnnalsATS.202308-673OC.
- Derived from this study: PubMed 37963297Thornton CS, Caverly LJ, Kalikin LM, Carmody LA, McClellan S, LeBar W, Sanders DB, West NE, Goss CH, Flume PA, Heltshe SL, VanDevanter DR, LiPuma JJ. Prevalence and Clinical Impact of Respiratory Viral Infections from the STOP2 Study of Cystic Fibrosis Pulmonary Exacerbations. Ann Am Thorac Soc. 2024 Apr;21(4):595-603. doi: 10.1513/AnnalsATS.202306-576OC.
- Derived from this study: PubMed 35300932Gold 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.
- Derived from this study: PubMed 34933824VanDevanter 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.
- Derived from this study: PubMed 34469706Goss 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.
- Derived from this study: PubMed 34159577Holland 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Goss, MD principal investigator
University of Washington
Patrick Flume, MD principal investigator
Medical University of South Carolina
58 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Pulmonary Cystic Fibrosis, run by Chris Goss at 58 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 to 14 days after the end of IV antibiotic treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02781610, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.