Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U01HL128954 | U.S. NIH Grant/Contract | View source |
Not provided
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Terminated for futility after review of first planned interim analysis.
Not provided
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| Name | Class |
|---|---|
| Duke Clinical Research Institute | OTHER |
| University of Chicago | OTHER |
| University of Washington | OTHER |
| University of Pittsburgh |
Not provided
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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).
This is a randomized, un-blinded, phase III, multi-center clinical trial of an antimicrobial therapy strategy in idiopathic pulmonary fibrosis patients. Our overall hypothesis is that reducing harmful microbial impact with antimicrobial therapy will reduce the risk of non-elective, respiratory hospitalization or death in patients with Idiopathic Pulmonary Fibrosis (IPF).
Subjects will be randomized 1:1 to either receive a prescription drug voucher for oral antimicrobial therapy in the form of one double strength 160 milligrams (mg) trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms (kg) or 100mg twice daily if weight > 50 kg. Patients randomized to receive antimicrobial therapy will be given co-trimoxazole unless they have an allergy, contraindication to co-trimoxazole, renal insufficiency (glomerular filtration rate (GFR) < 30 milliliters (ml)), are hyperkalemic (potassium > 5 milliequivalents(mEq)/liter(L)), or are concomitantly taking an angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), or potassium sparing diuretic in which case they will receive doxycycline.
Participation in this study will be between 12 months and 36 months depending on time of enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antimicrobial therapy | Experimental | Co-trimoxazole OR doxycycline |
|
| Standard of care | Other | Standard of care for patients with IPF for comparison |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antimicrobial therapy: Co-trimoxazole or Doxycycline | Drug | 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality | Randomization to up to 35 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Death From Any Cause | Randomization to up to 35 months | |
| Number of Participants With First Non-elective, Respiratory Hospitalization | Randomization to up to 35 months | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Received antimicrobial therapy in the past 30 days
Contraindicated for antibiotic therapy, including but not exclusive to:
Allergy or intolerance to both tetracyclines AND trimethoprim, sulfonamides or their combination
Allergy or intolerance to tetracyclines AND known potassium level > 5 mEq/L in the past 90 days.
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
Allergy or intolerance to tetracyclines AND known glucose-6-phosphate dehydrogenase deficiency
Allergy or intolerance to tetracyclines AND untreated folate or B12 deficiency
Allergy or intolerance to tetracyclines AND known renal insufficiency (defined as a glomerular filtration rate (GFR) < 30 ml within the previous 90 days)
Pregnant or anticipate becoming pregnant
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.
Concomitant immunosuppression with azathioprine, mycophenolate, cyclophosphamide, or cyclosporine.
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Martinez, MD, MS | Weill Cornell Medical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38030064 | Derived | Kim JS, Murray S, Yow E, Anstrom KJ, Kim HJ, Flaherty KR, Martinez FJ, Noth I. Comparison of Pirfenidone and Nintedanib: Post Hoc Analysis of the CleanUP-IPF Study. Chest. 2024 May;165(5):1163-1173. doi: 10.1016/j.chest.2023.11.035. Epub 2023 Nov 27. | |
| 33974018 | Derived | Martinez FJ, Yow E, Flaherty KR, Snyder LD, Durheim MT, Wisniewski SR, Sciurba FC, Raghu G, Brooks MM, Kim DY, Dilling DF, Criner GJ, Kim H, Belloli EA, Nambiar AM, Scholand MB, Anstrom KJ, Noth I; CleanUP-IPF Investigators of the Pulmonary Trials Cooperative. Effect of Antimicrobial Therapy on Respiratory Hospitalization or Death in Adults With Idiopathic Pulmonary Fibrosis: The CleanUP-IPF Randomized Clinical Trial. JAMA. 2021 May 11;325(18):1841-1851. doi: 10.1001/jama.2021.4956. |
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All collected IPD will be uploaded in a de-identified manner into BioLINCC with open access for interested investigators
Within a year of the primary paper publication and then indefinitely maintained by BioLINCC
The data will be open access for interested investigators
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Antimicrobial Therapy Plus Standard of Care | Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 28, 2016 | Dec 14, 2020 |
Not provided
Not provided
| OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| No Intervention: Standard of Care | Other | Standard of care |
|
| Number of Participants With First Non-elective, All-cause Hospitalization |
| Randomization to up to 35 months |
| Total Number of Non-elective Respiratory Hospitalizations | Randomization to up to 35 months |
| Total Number of Non-elective All-cause Hospitalizations | Randomization to up to 35 months |
| Percent Change in Forced Vital Capacity (FVC) | Randomization to 12 months |
| Percent Change in Diffusion Capacity of Lungs for Carbon Monoxide (DLCO) | Randomization to 12 months |
| Total Number of Respiratory Infections | Randomization to up to 35 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Tucson |
| Arizona |
| 85724 |
| United States |
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| Stanford | Stanford | California | 94305 | United States |
| Loyola University Chicago | Chicago | Illinois | 60153 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| University of Kansas | Kansas City | Kansas | 66160 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Mayo Clinic | Rochester | New York | 55905 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Ohio State | Columbus | Ohio | 43221 | United States |
| Pennsylvania State University | Hershey | Pennsylvania | 17033 | United States |
| Temple University | Philadelphia | Pennsylvania | 19122 | United States |
| Vanderbilt | Nashville | Tennessee | 37232 | United States |
| University of Texas at San Antonio | San Antonio | Texas | 78229 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| INOVA | Falls Church | Virginia | 22042 | United States |
| Washington University | Seattle | Washington | 98195 | United States |
| 32164673 | Derived | Anstrom KJ, Noth I, Flaherty KR, Edwards RH, Albright J, Baucom A, Brooks M, Clark AB, Clausen ES, Durheim MT, Kim DY, Kirchner J, Oldham JM, Snyder LD, Wilson AM, Wisniewski SR, Yow E, Martinez FJ; CleanUP-IPF Study Team. Design and rationale of a multi-center, pragmatic, open-label randomized trial of antimicrobial therapy - the study of clinical efficacy of antimicrobial therapy strategy using pragmatic design in Idiopathic Pulmonary Fibrosis (CleanUP-IPF) clinical trial. Respir Res. 2020 Mar 12;21(1):68. doi: 10.1186/s12931-020-1326-1. |
| FG001 |
| Standard of Care |
Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Antimicrobial Therapy Plus Standard of Care | Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months |
| BG001 | Standard of Care | Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Medical History | Data could not be located. | Count of Participants | Participants |
| |||||||||||||||
| Physical Exam | Data could not be located. | Count of Participants | Participants |
| |||||||||||||||
| Standard of Care medications | Data could not be located. | Count of Participants | Participants |
| |||||||||||||||
| Prior medications | Data could not be located. | Count of Participants | Participants |
| |||||||||||||||
| Forced Expiratory Volume in 1 second (FEV1) | Data could not be located. | Mean | Standard Deviation | Liters |
| ||||||||||||||
| Forced expiratory volume in 1 second (FEV1) percent predicted | Data could not be located. | Mean | Standard Deviation | percent predicted |
| ||||||||||||||
| Forced expiratory volume (FEV1)/Forced vital capacity (FVC) percentage | Data could not be located. | Mean | Standard Deviation | percent |
| ||||||||||||||
| Forced vital capacity (FVC) | Data could not be located. | Mean | Standard Deviation | Liters |
| ||||||||||||||
| Forced vital capacity (FVC) percent predicted | Data could not be located. | Mean | Standard Deviation | percent predicted |
| ||||||||||||||
| Diffusing capacity of the lung for carbon monoxide (DCLO) | Data could not be located. | Mean | Standard Deviation | mL/min/mmHg |
| ||||||||||||||
| Diffusing capacity of the lung for carbon monoxide (DLCO) corrected | Data could not be located. | Mean | Standard Deviation | mL/min/mmHg |
| ||||||||||||||
| Diffusing capacity of the lung for carbon monoxide (DLCO) percent predicted (actual) | Data could not be located. | Mean | Standard Deviation | percent predicted |
| ||||||||||||||
| Diffusing capacity of the lung for carbon monoxide (DLCO) percent predicted (corrected) | Data could not be located. | Mean | Standard Deviation | percent |
| ||||||||||||||
| Diffusing capacity of the lung for carbon monoxide (DLCO) percent predicted (best available) | Data could not be located. | Mean | Standard Deviation | percent |
| ||||||||||||||
| GAP stage | The GAP stage assessment system is a clinical prediction tool that estimates prognosis in patients with idiopathic pulmonary fibrosis. The GAP model includes four baseline variables that were found to be predictive of outcome, as identified by logistic regression. These factors are: gender (G), age (A) and two lung physiology variables (P) (forced vital capacity and diffusing capacity of the lung for carbon monoxide). A higher stage indicates a higher rate of mortality. One year mortality rates by stage: Stage I = 6% Stage II=16% Stage III = 39% | Data could not be located. | Number | participants |
| ||||||||||||||
| University of California San Diego (UCSD) shortness of breath questionnaire total score | University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ) total score (0 - 120 range). A lower score indicates a better health score. The UCSD SOBQ is a 24-item self-administered questionnaire that assesses dyspnea associated with activities of daily living. | Data could not be located. | Mean | Standard Deviation | Scores on a scale |
| |||||||||||||
| EuroQoL index score | EuroQoL score (0 - 1 range). A higher score indicates a better health score. This self-administered instrument includes five health state items (e.g. mobility, self-care). | Data could not be located. | Mean | Standard Deviation | Scores on a scale |
| |||||||||||||
| EuroQoL thermometer response | EuroQoL visual analog scale (0 - 100 range). A higher score indicates a better health score. Includes a 0-100 "thermometer" rating of current state of health from 0 as worst imaginable to 100 as best. | Data could not be located. | Mean | Standard Deviation | Scores on a scale |
| |||||||||||||
| ICEpop CAPability Measure for Older People (ICECAP-O) Score summary score | ICEpop CAPability Measure for Older People (ICECAP-O) Score (0 - 1 range). A lower score indicates a better health score. The ICECAP-O is a measure of capability in older people for use in economic evaluation. | Data could not be located. | Mean | Standard Deviation | Scores on a scale |
| |||||||||||||
| SF12 mental component summary (MCS) score | Short Form-12 mental component summary (MCS) score (0 - 100 range). A higher score indicates a better health score. The Short Form 12 MSC score assess mental health and well-being. | Data could not be located. | Mean | Standard Deviation | score on a scale |
| |||||||||||||
| SF12 physical component summary (PCS) score | Short form-12 physical components summary (PSC) score (0 - 100 range). A higher score indicates a better health score. The Short form-12 PSC score assesses limitations in physical activity because of health problems. | Data could not be located. | Mean | Standard Deviation | Scores on a scale |
| |||||||||||||
| SF6D score (economic evaluation) | Short form-12 6D health survey score (0.29 - 1.00 range). A higher score indicates a better health score. The Short form-12 6D health survey provides an economical evaluation. | Data could not be located. | Mean | Standard Deviation | Scores on a scale |
| |||||||||||||
| Fatigue Severity Scale score | Fatigue Severity Score (1 - 7 range). A lower score indicates a better health score. The fatigue severity questionnaire measures how fatigue impacts one's ability to function in the last week. | Data could not be located. | Mean | Standard Deviation | Scores on a scale |
| |||||||||||||
| Leicester cough questionnaire total score | Leicester cough questionnaire total score (3 - 21 range). A higher score indicates a better health score. The Leicester cough questionnaire assesses symptoms of cough frequency and severity. | Data could not be located. | Mean | Standard Deviation | Scores on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality | Posted | Count of Participants | Participants | Randomization to up to 35 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Death From Any Cause | Posted | Count of Participants | Participants | Randomization to up to 35 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With First Non-elective, Respiratory Hospitalization | Posted | Count of Participants | Participants | Randomization to up to 35 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With First Non-elective, All-cause Hospitalization | Posted | Count of Participants | Participants | Randomization to up to 35 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Number of Non-elective Respiratory Hospitalizations | Posted | Number | hospitalizations | Randomization to up to 35 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Number of Non-elective All-cause Hospitalizations | Posted | Number | hospitalizations | Randomization to up to 35 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Forced Vital Capacity (FVC) | Posted | Mean | 95% Confidence Interval | percent change | Randomization to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Diffusion Capacity of Lungs for Carbon Monoxide (DLCO) | Posted | Mean | 95% Confidence Interval | percent change | Randomization to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Number of Respiratory Infections | Posted | Number | 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. | Posted | Mean | 95% Confidence Interval | Scores on a scale | 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. | Posted | Mean | 95% Confidence Interval | Scores on a scale | 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. | Posted | Mean | 95% Confidence Interval | Scores on a scale | 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. | Posted | Mean | 95% Confidence Interval | Scores on a scale | 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. | Posted | Mean | 95% Confidence Interval | Scores on a scale | 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. | Posted | Mean | 95% Confidence Interval | Scores on a scale | 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. | Posted | Mean | 95% Confidence Interval | Scores on a scale | 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. | Posted | Mean | 95% Confidence Interval | Scores on a scale | Randomization to 12 months |
|
|
Thirty-five months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Antimicrobial Therapy Plus Standard of Care | Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months | 37 | 254 | 71 | 254 | 62 | 254 |
| EG001 | Standard of Care | Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care | 37 | 259 | 65 | 259 | 23 | 259 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embollism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Cardiac disorder | Cardiac disorders | Systematic Assessment |
| ||
| Nervous system disorder | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Gastrointestinal disorder | Gastrointestinal disorders | Systematic Assessment |
| ||
| General disorders and administrative site conditions | General disorders | Systematic Assessment |
| ||
| Metabolic and nutrition disorders | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Musculoskeletal and connective tissue disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Vascular disorders | Vascular disorders | Systematic Assessment |
| ||
| Injury, poisoning, and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Renal and urinary disorders | Renal and urinary disorders | Systematic Assessment |
| ||
| Hepatobiliary disorders | Hepatobiliary disorders | Systematic Assessment |
| ||
| Neoplasm benign, malignant, and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Endocrine disorders | Endocrine disorders | Systematic Assessment |
| ||
| Immune system disorders | Immune system disorders | Systematic Assessment |
| ||
| Investigations | Investigations | Systematic Assessment |
| ||
| Product issues | Product Issues | Systematic Assessment |
| ||
| Infections and infestations | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Peters | Weill Cornell Medicine | 646-962-2742 | elp2018@med.cornell.edu |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 2, 2018 | Dec 17, 2020 | Prot_001.pdf |
Not provided
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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| Myocardial infarct |
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| Valvular heart disease |
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| Congestive heart failure |
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| Stroke |
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| Osteoarthritis |
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| Osteoporosis |
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| Hypertension |
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| High cholesterol |
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| Stomach ulcers |
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| Hay fever |
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| Atrial fibrillation |
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| Intermittent claudication |
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| Peripheral vascular disease |
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| Cerebrovascular disease |
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| Dementia |
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| Chronic pulmonary disease |
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| Connective tissue disease |
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| Ulcer disease |
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| Mild liver disease |
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| Diabetes |
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| Hemiplegia |
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| Moderate or sever renal disease |
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| Diabetes with end organ damage |
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| Any tumor |
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| Leukemia |
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| Moderate or severe disease |
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| Metastatic solid tumor |
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| AIDS |
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| Lung cancer |
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| Other cancer (excluding basal cell carcinoma) |
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| Gastroesophageal reflux disease (GERD) |
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| Asthma |
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| Evidence of pulmonary hypertension |
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| Emphysema or chronic bronchitis |
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| Lymphoma |
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| Bibasilar, inspiratory crackles |
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| Jugular venous distension |
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| Increased P2 |
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| Peripheral edema |
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| Other significant finding |
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| Nintedanib |
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| H2 blockers (H2 receptor antagonists) |
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| Chronic prednisone (> 1 month) |
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| Azathioprine |
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| N-acetylcysteine (NAC) |
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| Co-trimoxazole |
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| Doxycycline |
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| II |
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| III |
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