Idiopathic Pulmonary Fibrosis
Conditions
Keywords
Idiopathic Pulmonary Fibrosis, IPF, pulmonary fibrosis, antimicrobial therapy, doxycycline, co-trimoxazole
Brief summary
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).
Detailed description
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.
Interventions
DRUGAntimicrobial 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
OTHERNo Intervention: Standard of Care
Standard of care
Sponsors
Duke Clinical Research Institute
University of Chicago
University of Washington
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality | Randomization to up to 35 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 Diffusion Capacity of Lungs for Carbon Monoxide (DLCO) | Randomization to 12 months | — |
| Total Number of Respiratory Infections | Randomization to up to 35 months | — |
| Percent Change in Forced Vital Capacity (FVC) | Randomization to 12 months | — |
| Change in Fatigue Severity Scale Score | Randomization to 12 months | 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. |
| Change in Leicester Cough Questionnaire Score | Randomization to 12 months | 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. |
| Change in EuroQol Index (EQ-5D) Score | Randomization to 12 months | 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. |
| Change in ICEpop CAPability Measure for Older People (ICECAP-O) Score | Randomization to 12 months | 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. |
| Change in Short Form-12 Health Survey (SF-12) 6D Score | Randomization to 12 months | 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. |
| Change in Short Form-12 Health Survey (SF-12) Physical Score | Randomization to 12 months | 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. |
| Change in SF-12 Health Survey (SF-12) Mental Score | Randomization to 12 months | 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. |
| Change in UCSD-Shortness of Breath Questionnaire | Randomization to 12 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 254 |
| Standard of Care Standard of care for patients with IPF for comparison
No Intervention: Standard of Care: Standard of care | 259 |
| Total | 513 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 34 | 36 |
| Overall Study | Lost to Follow-up | 4 | 7 |
| Overall Study | Lung transplant | 3 | 5 |
| Overall Study | Moved out of area | 3 | 4 |
| Overall Study | Other reason not completed | 10 | 12 |
| Overall Study | Physician Decision | 3 | 0 |
| Overall Study | Withdrawal by Subject | 28 | 15 |
Baseline characteristics
| Characteristic | Standard of Care | Total | Antimicrobial Therapy Plus Standard of Care |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 215 Participants | 421 Participants | 206 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 92 Participants | 48 Participants |
| Diffusing capacity of the lung for carbon monoxide (DCLO) | 11.74 mL/min/mmHg STANDARD_DEVIATION 4.414 | 11.62 mL/min/mmHg STANDARD_DEVIATION 4.518 | 11.50 mL/min/mmHg STANDARD_DEVIATION 4.63 |
| Diffusing capacity of the lung for carbon monoxide (DLCO) corrected | 192 mL/min/mmHg STANDARD_DEVIATION 4.466 | 11.59 mL/min/mmHg STANDARD_DEVIATION 4.393 | 11.42 mL/min/mmHg STANDARD_DEVIATION 4.323 |
| Diffusing capacity of the lung for carbon monoxide (DLCO) percent predicted (actual) | 39.78 percent predicted STANDARD_DEVIATION 13.832 | 40.11 percent predicted STANDARD_DEVIATION 15.288 | 40.48 percent predicted STANDARD_DEVIATION 16.738 |
| Diffusing capacity of the lung for carbon monoxide (DLCO) percent predicted (best available) | 40.11 percent STANDARD_DEVIATION 13.814 | 40.38 percent STANDARD_DEVIATION 15.384 | 40.68 percent STANDARD_DEVIATION 16.939 |
| Diffusing capacity of the lung for carbon monoxide (DLCO) percent predicted (corrected) | 40.00 percent STANDARD_DEVIATION 13.988 | 40.10 percent STANDARD_DEVIATION 14.487 | 40.20 percent STANDARD_DEVIATION 15.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 23 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 249 Participants | 490 Participants | 241 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| EuroQoL index score | 0.80 Scores on a scale STANDARD_DEVIATION 0.173 | 0.80 Scores on a scale STANDARD_DEVIATION 0.182 | 0.80 Scores on a scale STANDARD_DEVIATION 0.191 |
| EuroQoL thermometer response | 69.78 Scores on a scale STANDARD_DEVIATION 20.044 | 69.33 Scores on a scale STANDARD_DEVIATION 21.19 | 68.90 Scores on a scale STANDARD_DEVIATION 22.286 |
| Fatigue Severity Scale score | 3.98 Scores on a scale STANDARD_DEVIATION 1.708 | 3.90 Scores on a scale STANDARD_DEVIATION 1.633 | 3.81 Scores on a scale STANDARD_DEVIATION 1.554 |
| Forced expiratory volume (FEV1)/Forced vital capacity (FVC) percentage | 73.46 percent STANDARD_DEVIATION 2.098 | 73.57 percent STANDARD_DEVIATION 2.118 | 73.68 percent STANDARD_DEVIATION 2.138 |
| Forced Expiratory Volume in 1 second (FEV1) | 2.23 Liters STANDARD_DEVIATION 0.624 | 2.22 Liters STANDARD_DEVIATION 0.622 | 2.20 Liters STANDARD_DEVIATION 0.621 |
| Forced expiratory volume in 1 second (FEV1) percent predicted | 77.01 percent predicted STANDARD_DEVIATION 18.195 | 77.87 percent predicted STANDARD_DEVIATION 18.916 | 78.79 percent predicted STANDARD_DEVIATION 19.656 |
| Forced vital capacity (FVC) | 2.78 Liters STANDARD_DEVIATION 0.848 | 2.75 Liters STANDARD_DEVIATION 0.824 | 2.71 Liters STANDARD_DEVIATION 0.798 |
| Forced vital capacity (FVC) percent predicted | 70.20 percent predicted STANDARD_DEVIATION 17.683 | 70.76 percent predicted STANDARD_DEVIATION 17.863 | 71.36 percent predicted STANDARD_DEVIATION 18.071 |
| GAP stage I | 54 participants | 144 participants | 60 participants |
| GAP stage II | 133 participants | 257 participants | 124 participants |
| GAP stage III | 64 participants | 113 participants | 49 participants |
| ICEpop CAPability Measure for Older People (ICECAP-O) Score summary score | 0.36 Scores on a scale STANDARD_DEVIATION 0.209 | 0.36 Scores on a scale STANDARD_DEVIATION 0.213 | 0.35 Scores on a scale STANDARD_DEVIATION 0.217 |
| Leicester cough questionnaire total score | 17.19 Scores on a scale STANDARD_DEVIATION 3.589 | 16.95 Scores on a scale STANDARD_DEVIATION 3.638 | 16.71 Scores on a scale STANDARD_DEVIATION 3.681 |
| Medical History AIDS | 0 Participants | 0 Participants | 0 Participants |
| Medical History Any tumor | 16 Participants | 37 Participants | 21 Participants |
| Medical History Asthma | 12 Participants | 26 Participants | 14 Participants |
| Medical History Atrial fibrillation | 31 Participants | 52 Participants | 21 Participants |
| Medical History Cerebrovascular disease | 4 Participants | 7 Participants | 3 Participants |
| Medical History Chronic pulmonary disease | 163 Participants | 314 Participants | 151 Participants |
| Medical History Congestive heart failure | 12 Participants | 20 Participants | 8 Participants |
| Medical History Connective tissue disease | 1 Participants | 3 Participants | 2 Participants |
| Medical History Coronary artery disease | 79 Participants | 148 Participants | 69 Participants |
| Medical History Dementia | 3 Participants | 3 Participants | 0 Participants |
| Medical History Diabetes | 39 Participants | 88 Participants | 49 Participants |
| Medical History Diabetes with end organ damage | 1 Participants | 1 Participants | 0 Participants |
| Medical History Emphysema or chronic bronchitis | 28 Participants | 53 Participants | 25 Participants |
| Medical History Evidence of pulmonary hypertension | 21 Participants | 40 Participants | 19 Participants |
| Medical History Gastroesophageal reflux disease (GERD) | 149 Participants | 305 Participants | 156 Participants |
| Medical History Hay fever | 46 Participants | 97 Participants | 51 Participants |
| Medical History Hemiplegia | 1 Participants | 1 Participants | 0 Participants |
| Medical History High cholesterol | 154 Participants | 298 Participants | 144 Participants |
| Medical History Hypertension | 129 Participants | 256 Participants | 127 Participants |
| Medical History Intermittent claudication | 7 Participants | 9 Participants | 2 Participants |
| Medical History Leukemia | 1 Participants | 1 Participants | 0 Participants |
| Medical History Lung cancer | 4 Participants | 7 Participants | 3 Participants |
| Medical History Lymphoma | 2 Participants | 3 Participants | 1 Participants |
| Medical History Metastatic solid tumor | 0 Participants | 1 Participants | 1 Participants |
| Medical History Mild liver disease | 5 Participants | 12 Participants | 7 Participants |
| Medical History Moderate or severe disease | 3 Participants | 7 Participants | 4 Participants |
| Medical History Moderate or sever renal disease | 8 Participants | 17 Participants | 9 Participants |
| Medical History Myocardial infarct | 32 Participants | 52 Participants | 20 Participants |
| Medical History Osteoarthritis | 73 Participants | 139 Participants | 66 Participants |
| Medical History Osteoporosis | 11 Participants | 30 Participants | 19 Participants |
| Medical History Other cancer (excluding basal cell carcinoma) | 37 Participants | 76 Participants | 39 Participants |
| Medical History Peripheral vascular disease | 11 Participants | 20 Participants | 9 Participants |
| Medical History Stomach ulcers | 16 Participants | 28 Participants | 12 Participants |
| Medical History Stroke | 10 Participants | 19 Participants | 9 Participants |
| Medical History Ulcer disease | 3 Participants | 7 Participants | 4 Participants |
| Medical History Valvular heart disease | 13 Participants | 20 Participants | 7 Participants |
| Physical Exam Bibasilar, inspiratory crackles | 240 Participants | 478 Participants | 238 Participants |
| Physical Exam Clubbing | 51 Participants | 92 Participants | 41 Participants |
| Physical Exam Increased P2 | 8 Participants | 15 Participants | 7 Participants |
| Physical Exam Jugular venous distension | 4 Participants | 8 Participants | 4 Participants |
| Physical Exam Other significant finding | 10 Participants | 23 Participants | 13 Participants |
| Physical Exam Peripheral edema | 20 Participants | 36 Participants | 16 Participants |
| Prior medications Azathioprine | 3 Participants | 4 Participants | 1 Participants |
| Prior medications Chronic prednisone (> 1 month) | 53 Participants | 96 Participants | 43 Participants |
| Prior medications Co-trimoxazole | 38 Participants | 81 Participants | 43 Participants |
| Prior medications Doxycycline | 41 Participants | 95 Participants | 54 Participants |
| Prior medications H2 blockers (H2 receptor antagonists) | 53 Participants | 102 Participants | 49 Participants |
| Prior medications N-acetylcysteine (NAC) | 13 Participants | 27 Participants | 14 Participants |
| Prior medications Proton pump inhibitors (PPI) | 158 Participants | 316 Participants | 158 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 14 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 12 Participants | 7 Participants |
| Race (NIH/OMB) White | 244 Participants | 475 Participants | 231 Participants |
| Region of Enrollment United States | 259 participants | 513 participants | 254 participants |
| Sex: Female, Male Female | 51 Participants | 111 Participants | 60 Participants |
| Sex: Female, Male Male | 208 Participants | 402 Participants | 194 Participants |
| SF12 mental component summary (MCS) score | 0.36 score on a scale STANDARD_DEVIATION 0.209 | 0.36 score on a scale STANDARD_DEVIATION 0.213 | 0.35 score on a scale STANDARD_DEVIATION 0.217 |
| SF12 physical component summary (PCS) score | 40.23 Scores on a scale STANDARD_DEVIATION 9.171 | 40.83 Scores on a scale STANDARD_DEVIATION 8.991 | 41.46 Scores on a scale STANDARD_DEVIATION 8.776 |
| SF6D score (economic evaluation) | 0.72 Scores on a scale STANDARD_DEVIATION 0.114 | 0.72 Scores on a scale STANDARD_DEVIATION 0.115 | 0.72 Scores on a scale STANDARD_DEVIATION 0.115 |
| Standard of Care medications Nintedanib | 97 Participants | 198 Participants | 101 Participants |
| Standard of Care medications Pirfenidone | 160 Participants | 318 Participants | 158 Participants |
| University of California San Diego (UCSD) shortness of breath questionnaire total score | 32.91 Scores on a scale STANDARD_DEVIATION 32.91 | 32.77 Scores on a scale STANDARD_DEVIATION 32.77 | 32.62 Scores on a scale STANDARD_DEVIATION 24.246 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 37 / 254 | 37 / 259 |
| other Total, other adverse events | 62 / 254 | 23 / 259 |
| serious Total, serious adverse events | 71 / 254 | 65 / 259 |
Outcome results
Primary
Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality
Time frame: Randomization to up to 35 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Antimicrobial Therapy Plus Standard of Care | Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality | 52 Participants |
| Standard of Care | Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality | 56 Participants |
p-value: 0.8395% CI: [0.71, 1.53]Regression, Cox
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.
Time frame: Randomization to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Antimicrobial Therapy Plus Standard of Care | Change in EuroQol Index (EQ-5D) Score | -0.040 Scores on a scale |
| Standard of Care | Change in EuroQol Index (EQ-5D) Score | -0.046 Scores on a scale |
p-value: 0.7695% CI: [-4.64, 3.39]Regression, Cox
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.
Time frame: Randomization to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Antimicrobial Therapy Plus Standard of Care | Change in Fatigue Severity Scale Score | 0.24 Scores on a scale |
| Standard of Care | Change in Fatigue Severity Scale Score | 0.13 Scores on a scale |
p-value: 0.5495% CI: [-0.24, 0.46]Regression, Cox
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.
Time frame: Randomization to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Antimicrobial Therapy Plus Standard of Care | Change in ICEpop CAPability Measure for Older People (ICECAP-O) Score | 0.027 Scores on a scale |
| Standard of Care | Change in ICEpop CAPability Measure for Older People (ICECAP-O) Score | 0.017 Scores on a scale |
p-value: 0.6395% CI: [-0.031, 0.051]Regression, Cox
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.
Time frame: Randomization to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Antimicrobial Therapy Plus Standard of Care | Change in Leicester Cough Questionnaire Score | -0.58 Scores on a scale |
| Standard of Care | Change in Leicester Cough Questionnaire Score | -0.58 Scores on a scale |
p-value: 0.9995% CI: [-0.79, 0.8]Regression, Linear
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.
Time frame: Randomization to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Antimicrobial Therapy Plus Standard of Care | Change in SF-12 Health Survey (SF-12) Mental Score | -1.29 Scores on a scale |
| Standard of Care | Change in SF-12 Health Survey (SF-12) Mental Score | -1.59 Scores on a scale |
p-value: 0.7595% CI: [-1.61, 2.2]Regression, Linear
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.
Time frame: Randomization to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Antimicrobial Therapy Plus Standard of Care | Change in Short Form-12 Health Survey (SF-12) 6D Score | -0.013 Scores on a scale |
| Standard of Care | Change in Short Form-12 Health Survey (SF-12) 6D Score | -0.031 Scores on a scale |
p-value: 0.1595% CI: [-0.007, 0.043]Regression, Cox
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.
Time frame: Randomization to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Antimicrobial Therapy Plus Standard of Care | Change in Short Form-12 Health Survey (SF-12) Physical Score | -1.36 Scores on a scale |
| Standard of Care | Change in Short Form-12 Health Survey (SF-12) Physical Score | -1.88 Scores on a scale |
p-value: 0.5395% CI: [-1.11, 2.15]Regression, Cox
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.
Time frame: Randomization to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Antimicrobial Therapy Plus Standard of Care | Change in UCSD-Shortness of Breath Questionnaire | 5.67 Scores on a scale |
| Standard of Care | Change in UCSD-Shortness of Breath Questionnaire | 6.29 Scores on a scale |
p-value: 0.7695% CI: [-4.64, 3.39]Regression, Cox
Secondary
Number of Participants With Death From Any Cause
Time frame: Randomization to up to 35 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Antimicrobial Therapy Plus Standard of Care | Number of Participants With Death From Any Cause | 37 Participants |
| Standard of Care | Number of Participants With Death From Any Cause | 37 Participants |
p-value: 0.6595% CI: [0.7, 1.78]Regression, Cox
Secondary
Number of Participants With First Non-elective, All-cause Hospitalization
Time frame: Randomization to up to 35 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Antimicrobial Therapy Plus Standard of Care | Number of Participants With First Non-elective, All-cause Hospitalization | 54 Participants |
| Standard of Care | Number of Participants With First Non-elective, All-cause Hospitalization | 47 Participants |
p-value: 0.1395% CI: [0.91, 2.01]Regression, Cox
Secondary
Number of Participants With First Non-elective, Respiratory Hospitalization
Time frame: Randomization to up to 35 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Antimicrobial Therapy Plus Standard of Care | Number of Participants With First Non-elective, Respiratory Hospitalization | 36 Participants |
| Standard of Care | Number of Participants With First Non-elective, Respiratory Hospitalization | 31 Participants |
p-value: 0.2595% CI: [0.82, 2.17]Regression, Cox
Secondary
Percent Change in Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)
Time frame: Randomization to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Antimicrobial Therapy Plus Standard of Care | Percent Change in Diffusion Capacity of Lungs for Carbon Monoxide (DLCO) | -1.72 percent change |
| Standard of Care | Percent Change in Diffusion Capacity of Lungs for Carbon Monoxide (DLCO) | -2.56 percent change |
p-value: 0.5195% CI: [-1.67, 3.35]Regression, Cox
Secondary
Percent Change in Forced Vital Capacity (FVC)
Time frame: Randomization to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Antimicrobial Therapy Plus Standard of Care | Percent Change in Forced Vital Capacity (FVC) | -2.99 percent change |
| Standard of Care | Percent Change in Forced Vital Capacity (FVC) | -4.13 percent change |
p-value: 0.1995% CI: [-0.56, 2.83]Regression, Cox
Secondary
Total Number of Non-elective All-cause Hospitalizations
Time frame: Randomization to up to 35 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Antimicrobial Therapy Plus Standard of Care | Total Number of Non-elective All-cause Hospitalizations | 72 hospitalizations |
| Standard of Care | Total Number of Non-elective All-cause Hospitalizations | 52 hospitalizations |
p-value: 0.1695% CI: [0.9, 1.83]Regression, Cox
Secondary
Total Number of Non-elective Respiratory Hospitalizations
Time frame: Randomization to up to 35 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Antimicrobial Therapy Plus Standard of Care | Total Number of Non-elective Respiratory Hospitalizations | 55 hospitalizations |
| Standard of Care | Total Number of Non-elective Respiratory Hospitalizations | 43 hospitalizations |
p-value: 0.495% CI: [0.78, 1.89]Regression, Cox
Secondary
Total Number of Respiratory Infections
Time frame: Randomization to up to 35 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Antimicrobial Therapy Plus Standard of Care | Total Number of Respiratory Infections | 34 respiratory infections |
| Standard of Care | Total Number of Respiratory Infections | 49 respiratory infections |
p-value: 0.1395% CI: [0.46, 1.11]Regression, Cox