CleanUP IPF for the Pulmonary Trials Cooperative

Idiopathic Pulmonary Fibrosis Clinical Trial

— CleanUp-IPF  

Official title:

Study of Clinical Efficacy of Antimicrobial Therapy Strategy Using Pragmatic Design in Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02759120
• Other study ID #: 1504016087
• Secondary ID: U01HL128954
• Status: Terminated
• Phase: Phase 3
• Start date: March 22, 2017
• Est. completion date: March 16, 2020

Study information

• Verified date: March 2021
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• 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

Other:
• No Intervention: Standard of Care
Standard of care

Locations

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

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

Outcome

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