Last updated on January 2019

CleanUP IPF for the Pulmonary Trials Cooperative


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02759120

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Albany Medical College

Albany, NY United States
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Weill Cornell Medicine

New York, NY United States
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Stanford

Stanford, CA United States
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Mayo Clinic

Rochester, NY United States
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Columbia University

New York, NY United States
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Spectrum Health

Grand Rapids, MI United States
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Northwestern University

Chicago, IL United States
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University of Minnesota

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University of Chicago

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University of Cincinnati

Cincinnati, OH United States
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University of Michigan

Ann Arbor, MI United States
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Cleveland Clinic

Cleveland, OH United States
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Temple University

Philadelphia, PA United States
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University of Utah

Salt Lake City, UT United States
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Loyola University Chicago

Chicago, IL United States
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Vanderbilt

Nashville, TN United States
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Washington University

Seattle, WA United States
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Recruitment Status: Open


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