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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02781610 |
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Date of registration:
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12/05/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Standardized Treatment of Pulmonary Exacerbations II
STOP2 |
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Scientific title:
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Standardized Treatment of Pulmonary Exacerbations II (STOP2) |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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1048 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02781610 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Chris Goss, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Washington |
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Name:
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Patrick Flume, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of South Carolina |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Cystic Fibrosis
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Intervention(s)
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Drug: Standard of care IV antibiotic(s)
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Primary Outcome(s)
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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]
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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]
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Secondary Outcome(s)
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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]
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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]
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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]
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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]
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Secondary ID(s)
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STOP2-IP-15
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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