Idiopathic Pulmonary Fibrosis Clinical Trial
— CleanUp-IPFOfficial title:
Study of Clinical Efficacy of Antimicrobial Therapy Strategy Using Pragmatic Design in Idiopathic Pulmonary Fibrosis
Verified date | March 2021 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the effect of standard care, versus standard of care plus antimicrobial therapy (co-trimoxazole or doxycycline), on clinical outcomes in patients diagnosed with idiopathic pulmonary fibrosis (IPF).
Status | Terminated |
Enrollment | 513 |
Est. completion date | March 16, 2020 |
Est. primary completion date | March 16, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: 1. = 40 years of age 2. Diagnosed with idiopathic pulmonary fibrosis (IPF) by enrolling investigator 3. Signed informed consent Exclusion Criteria: 1. Received antimicrobial therapy in the past 30 days 2. Contraindicated for antibiotic therapy, including but not exclusive to: 1. Allergy or intolerance to both tetracyclines AND trimethoprim, sulfonamides or their combination 2. Allergy or intolerance to tetracyclines AND known potassium level > 5 mEq/L in the past 90 days. - If the enrolling physician feels the potassium level has normalized, documentation to that effect must be provided. 3. Allergy or intolerance to tetracyclines AND concomitant use of angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), potassium sparing diuretic, dofetilide, methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide 4. Allergy or intolerance to tetracyclines AND known glucose-6-phosphate dehydrogenase deficiency 5. Allergy or intolerance to tetracyclines AND untreated folate or B12 deficiency 6. Allergy or intolerance to tetracyclines AND known renal insufficiency (defined as a glomerular filtration rate (GFR) < 30 ml within the previous 90 days) - If the enrolling physician feels the renal dysfunction has resolved, documentation to that effect must be provided. 3. Pregnant or anticipate becoming pregnant 4. Use of an investigational study agent for IPF therapy within the past 30 days, or an IV infusion with a half-life of four (4) weeks. 5. Concomitant immunosuppression with azathioprine, mycophenolate, cyclophosphamide, or cyclosporine. |
Country | Name | City | State |
---|---|---|---|
United States | Albany Medical College | Albany | New York |
United States | University of Michigan | Ann Arbor | Michigan |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | University of Virginia | Charlottesville | Virginia |
United States | Loyola University Chicago | Chicago | Illinois |
United States | Northwestern University | Chicago | Illinois |
United States | University of Chicago | Chicago | Illinois |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Ohio State | Columbus | Ohio |
United States | INOVA | Falls Church | Virginia |
United States | Spectrum Health | Grand Rapids | Michigan |
United States | Pennsylvania State University | Hershey | Pennsylvania |
United States | University of Kansas | Kansas City | Kansas |
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Vanderbilt | Nashville | Tennessee |
United States | Columbia University | New York | New York |
United States | Weill Cornell Medicine | New York | New York |
United States | Temple University | Philadelphia | Pennsylvania |
United States | Mayo Clinic | Rochester | New York |
United States | University of Rochester | Rochester | New York |
United States | University of California Davis Medical Center | Sacramento | California |
United States | University of Utah | Salt Lake City | Utah |
United States | University of Texas at San Antonio | San Antonio | Texas |
United States | Washington University | Seattle | Washington |
United States | Stanford | Stanford | California |
United States | University of Arizona | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | Duke Clinical Research Institute, National Heart, Lung, and Blood Institute (NHLBI), University of Chicago, University of Pittsburgh, University of Washington |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality | Randomization to up to 35 months | ||
Secondary | Number of Participants With Death From Any Cause | Randomization to up to 35 months | ||
Secondary | Number of Participants With First Non-elective, Respiratory Hospitalization | Randomization to up to 35 months | ||
Secondary | Number of Participants With First Non-elective, All-cause Hospitalization | Randomization to up to 35 months | ||
Secondary | Total Number of Non-elective Respiratory Hospitalizations | Randomization to up to 35 months | ||
Secondary | Total Number of Non-elective All-cause Hospitalizations | Randomization to up to 35 months | ||
Secondary | Percent Change in Forced Vital Capacity (FVC) | Randomization to 12 months | ||
Secondary | Percent Change in Diffusion Capacity of Lungs for Carbon Monoxide (DLCO) | Randomization to 12 months | ||
Secondary | Total Number of Respiratory Infections | Randomization to up to 35 months | ||
Secondary | Change in UCSD-Shortness of Breath Questionnaire | Change in University of California San Diego (UCSD) Shortness of Breath Questionnaire (0 - 120 range). A lower score indicates a better health score. The UCSD-Shortness of Breath Questionnaire assesses the severity of shortness of breath during specific activities of daily living. | Randomization to 12 months | |
Secondary | Change in Fatigue Severity Scale Score | Fatigue Severity Scale score (1 - 7 range). A lower score indicates a better health score. The Fatigue Severity Scale measures the severity of fatigue and its effect on a person's activities and lifestyle. | Randomization to 12 months | |
Secondary | Change in Leicester Cough Questionnaire Score | Leicester Cough Questionnaire score (3 - 21 range). A higher score indicates a better health score. The Leicester Cough Questionnaire measures quality of life in people with a chronic cough. | Randomization to 12 months | |
Secondary | Change in EuroQol Index (EQ-5D) Score | European Quality of Life-5 dimensions (EQ-5D) score (0 - 1 range). A higher score indicates a better health score. The EQ-5D measures quality of life across 5 dimensions (1. Mobility, 2. Self-care, 3. Usual activities, 4. Pain/discomfort, 5. Anxiety/depression. | Randomization to 12 months | |
Secondary | Change in ICEpop CAPability Measure for Older People (ICECAP-O) Score | Change in ICEpop (Investigating Choice Experiments for the Preferences of Older People) CAPability measure for Older people (ICECAP-O) score (0 - 1 range). A lower score indicates a better health score. The ICEpop CAPability measure for Older people (ICECAP-O) is intended for use in economic evaluations of care services for older people. | Randomization to 12 months | |
Secondary | Change in Short Form-12 Health Survey (SF-12) 6D Score | Change in Short Form-12 health survey (SF-12) 6D score (0.29 - 1.00 range). A higher indicates a better health score. The SF-12 6D score provides and economic evaluation. | Randomization to 12 months | |
Secondary | Change in Short Form-12 Health Survey (SF-12) Physical Score | Change in short form-12 health survey (SF-12) physical component summary (PSC) score (0 - 100 range). A higher score indicates a better health score.
The short form-12 health survey physical score assesses limitations in physical activities because of health problems. |
Randomization to 12 months | |
Secondary | Change in SF-12 Health Survey (SF-12) Mental Score | Change in short form-12 health survey (SF-12) mental component summary (MCS) score (0 - 100 range). A higher score indicates a better health score.
The short form-12 health survey (SF-12) mental component summary (MCS) assesses general mental health. |
Randomization to 12 months |
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