Contact a CleanUP IPF Trial Team

We’re linking those affected by IPF to world-renowned researchers conducting the CleanUp IPF trial at top-ranked medical centers. You have an opportunity to be part of a team working toward cures for this devastating disease. Please contact the CleanUP IPF Trial team listed below to learn more about trial participation.

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers No
Study Type Interventional
Eligible Ages 40 Years and Over
Gender All

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:
    • 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.
  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.
  7. Pregnant or anticipate becoming pregnant
  8. 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.
  9. Concomitant immunosuppression with azathioprine, mycophenolate, cyclophosphamide, or cyclosporine.

Trial Details

Trial ID: NCT02759120
Phase Phase 3

Lead Sponsor

Weill Medical College of Cornell University
Principal Investigator Fernando Martinez, MD, MS
Principal Investigator Affiliation Weill Cornell Medical Medicine
Agency Class Other Other Other Other Other
Overall Status Recruiting
Countries United States
Conditions Idiopathic Pulmonary Fibrosis

Additional Details

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.

University of Alabama at Birmingham, Birmingham, AL

Tracy Luckhardt, MD
[email protected]

University of Arizona, Tucson, AZ

Sachin Chaudhary, MD
[email protected]

University of California Davis Medical Center, Sacremento, CA

Justin Oldham, MD
jol[email protected]

Stanford University, Stanford, CA

Rishi Raj, MD
[email protected]

Loyola University, Chicago, IL

Dan Dilling, MD, FACP
[email protected]

Northwestern University, Chicago, IL

Sangeeta Bhorade, MD
[email protected]

University of Chicago, Chicago, IL

Mary Strek, MD
[email protected]

University of Kansas Medical Center, Kansas City, KC

Mark hamblin, MD
[email protected]

Beth Israel Deaconess Medical Center, Boston, MA

Joe Zibrack, MD
[email protected]

Brigham and Women’s Hospital, Boston, MA

Hilary Goldberg, MD
[email protected]

Massachusetts General Hospital, Boston, MA

Leo Ginns, MD
[email protected]

University of Michigan, Ann Arbor, MI

Beth Belloli, MD
[email protected]

Spectrum Health, Grand Rapids, MI

Shelley Schmidt, MD
[email protected]

University of Minnesota, Minneapolis, MN

Hyun Kim, MD
[email protected]

Mayo Clinic, Rochester, MN

Moua Teng, MD
[email protected]

Dartmouth-Hitchcock Medical Center, Lehanon, NH

Rick Enelow, MD
[email protected]

Albany Medical College, Albany, NY

Scott Beegle, MD
[email protected]

Columbia University, New York, NY

David Lederer, MD, MS
[email protected]

Weill Cornell Medicine, New York, NY

Robert Kaner, MD
[email protected]

University of Rochester, Rochester, NY

Matt Kottman, MD
[email protected]

University of Cincinnati, Cincinnati, OH

Nishant Gupta, MD, MS
[email protected]

Cleveland Clinic, Cleveland, OH

Daniel Culver, DO
[email protected]

Ohio State, Columbus, OH

Nitin Bhatt, MD
[email protected]

Penn State University, Hershey, PA

Rebecca Bascom, MD, MPh
[email protected]

Temple University, Philadelphia, PA

Gerard Criner, MD
[email protected]

Vanderbilt University, Nashville, TN

Lisa Lancaster, MD
[email protected]

University of Texas at San Antonio, San Antonio, TX

Anoop Nambiar, MD, MS
[email protected]

University of Utah, Salt Lake City, UT

Mary Beth Scholand, MD
[email protected]

University of Virginia, Charlottesville, VA

Imre Noth, MD
[email protected]

INOVA, Falls Church, VA

Christopher King, MD
[email protected]

University of Washington, Seattle, WA

Ganesh Raghu, MD
[email protected]