CleanUP IPF for the Pulmonary Trials Cooperative

Stopped early · Phase 3

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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).

Key facts

Study ID

NCT02759120

Run by

Weill Medical College of Cornell University

People needed

513

Starts

2017-03-22

Expected to finish

2020-03-16

Last updated by the study team

2021-04-08

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 40 years of age
• Diagnosed with idiopathic pulmonary fibrosis (IPF) by enrolling investigator
• Signed informed consent

You may not qualify if…

• 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.
• If the enrolling physician feels the potassium level has normalized, documentation to that effect must be provided.
• 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)
• If the enrolling physician feels the renal dysfunction has resolved, documentation to that effect must be provided.
• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Arizona — Tucson, Arizona, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Stanford — Stanford, California, United States
• Loyola University Chicago — Chicago, Illinois, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• University of Kansas — Kansas City, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Albany Medical College — Albany, New York, United States
• Columbia University — New York, New York, United States
• Weill Cornell Medicine — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Mayo Clinic — Rochester, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State — Columbus, Ohio, United States
• Pennsylvania State University — Hershey, Pennsylvania, United States
• Temple University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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