CleanUP IPF for the Pulmonary Trials Cooperative

Phase 3

Terminated

• Conditions: Idiopathic Pulmonary Fibrosis

• Registration Number: NCT02759120
• Lead Sponsor: Weill Medical College of Cornell University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2016-04-28
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-05-03
• Study Start: 2017-03-22
• Primary Completion: 2020-03-16
• Study Completion: 2020-03-16
• Results First Submitted: 2020-12-22
• Results First Submitted QC: 2021-02-09
• Status Verified: 2021-03
• Results First Posted: 2021-03-03
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 513

Inclusion Criteria

1. ≥ 40 years of age
2. Diagnosed with idiopathic pulmonary fibrosis (IPF) by enrolling investigator
3. Signed informed consent

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality	Randomization to up to 35 months

Secondary Outcome Measures

Name	Time	Method
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
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
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	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.
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.

Trial Locations

Locations (31)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Vanderbilt; 🇺🇸 Nashville, Tennessee, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Stanford; 🇺🇸 Stanford, California, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States

Loyola University Chicago; 🇺🇸 Chicago, Illinois, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Spectrum Health; 🇺🇸 Grand Rapids, Michigan, United States

Albany Medical College; 🇺🇸 Albany, New York, United States

Weill Cornell Medicine; 🇺🇸 New York, New York, United States

Columbia University; 🇺🇸 New York, New York, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Mayo Clinic; 🇺🇸 Rochester, New York, United States

Ohio State; 🇺🇸 Columbus, Ohio, United States

Pennsylvania State University; 🇺🇸 Hershey, Pennsylvania, United States

University of Texas at San Antonio; 🇺🇸 San Antonio, Texas, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

INOVA; 🇺🇸 Falls Church, Virginia, United States

Washington University; 🇺🇸 Seattle, Washington, United States

University of Kansas; 🇺🇸 Kansas City, Kansas, United States

University of Rochester; 🇺🇸 Rochester, New York, United States