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
tluckhardt@uabmc.edu
205-975-6770

University of Arizona, Tucson, AZ

Sachin Chaudhary, MD
sachin@deptofmed.arizona.edu
989-980-3228

University of California Davis Medical Center, Sacremento, CA

Justin Oldham, MD
joldham@ucdavis.edu
916-871-1522

Stanford University, Stanford, CA

Rishi Raj, MD
Rishi.Raj@stanford.edu
650-497-2929

Loyola University, Chicago, IL

Dan Dilling, MD, FACP
ddillin@lumc.edu
708-216-5404

Northwestern University, Chicago, IL

Sangeeta Bhorade, MD
sbhorade@nm.org
312-695-4015

University of Chicago, Chicago, IL

Mary Strek, MD
mstrek@medicine.bsd.uchicago.edu
773-702-1796

University of Kansas Medical Center, Kansas City, KC

Mark hamblin, MD
mhamblin@kumc.edu
913-588-6045

Beth Israel Deaconess Medical Center, Boston, MA

Joe Zibrack, MD
jzibrak@bidmc.harvard.edu
617-667-5864

Brigham and Women’s Hospital, Boston, MA

Hilary Goldberg, MD
hjgoldberg@bwh.harvard.edu
617-732-7420

Massachusetts General Hospital, Boston, MA

Leo Ginns, MD
Ginns.Leo@mgh.harvard.edu
617-726-1718

University of Michigan, Ann Arbor, MI

Beth Belloli, MD
bellolie@med.umich.edu
734-615-8383

Spectrum Health, Grand Rapids, MI

Shelley Schmidt, MD
shelley.schmidt@spectrumhealth.org
616-267-8244

University of Minnesota, Minneapolis, MN

Hyun Kim, MD
kimxx015@umn.edu
612-624-0999

Mayo Clinic, Rochester, MN

Moua Teng, MD
moua.teng@mayo.edu
212-746-6420

Dartmouth-Hitchcock Medical Center, Lehanon, NH

Rick Enelow, MD
Richard.I.Enelow@dartmouth.edu
603-650-5533

Albany Medical College, Albany, NY

Scott Beegle, MD
BeegleS@mail.amc.edu
212-746-6420

Columbia University, New York, NY

David Lederer, MD, MS
dl427@cumc.columbia.edu
212-305-8203

Weill Cornell Medicine, New York, NY

Robert Kaner, MD
rkaner@med.cornell.edu
646-962-2333

University of Rochester, Rochester, NY

Matt Kottman, MD
matt_kottmann@urmc.rochester.edu
585-275-4861

University of Cincinnati, Cincinnati, OH

Nishant Gupta, MD, MS
nishant.gupta@uc.edu
513-558-4858

Cleveland Clinic, Cleveland, OH

Daniel Culver, DO
culverd@ccf.org
212-746-6420

Ohio State, Columbus, OH

Nitin Bhatt, MD
nitin.bhatt@osumc.edu
212-746-6420

Penn State University, Hershey, PA

Rebecca Bascom, MD, MPh
rbascom@pennstatehealth.psu.edu
717-531-6526

Temple University, Philadelphia, PA

Gerard Criner, MD
Gerard.Criner@tuhs.temple.edu
215-707-8113

Vanderbilt University, Nashville, TN

Lisa Lancaster, MD
lisa.lancaster@vanderbilt.edu
615-343-7068

University of Texas at San Antonio, San Antonio, TX

Anoop Nambiar, MD, MS
nambiar@uthscsa.edu
210-567-6267

University of Utah, Salt Lake City, UT

Mary Beth Scholand, MD
scholand@genetics.utah.edu
801-581-5864

University of Virginia, Charlottesville, VA

Imre Noth, MD
in2c@hscmail.mcc.virginia.edu
434-297-7737

INOVA, Falls Church, VA

Christopher King, MD
christopher.king@inova.org
703-953-7837

University of Washington, Seattle, WA

Ganesh Raghu, MD
graghu@uw.edu
206-598-0440