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).

Condition

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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:
  3. Allergy or intolerance to both tetracyclines AND trimethoprim, sulfonamides or their combination
  4. Allergy or intolerance to tetracyclines AND known potassium level > 5 mEq/L in the past 90 days.
  5. If the enrolling physician feels the potassium level has normalized, documentation to that effect must be provided.
  6. 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
  7. Allergy or intolerance to tetracyclines AND known glucose-6-phosphate dehydrogenase deficiency
  8. Allergy or intolerance to tetracyclines AND untreated folate or B12 deficiency
  9. Allergy or intolerance to tetracyclines AND known renal insufficiency (defined as a glomerular filtration rate (GFR) < 30 ml within the previous 90 days)
  10. If the enrolling physician feels the renal dysfunction has resolved, documentation to that effect must be provided.
  11. Pregnant or anticipate becoming pregnant
  12. 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.
  13. Concomitant immunosuppression with azathioprine, mycophenolate, cyclophosphamide, or cyclosporine.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Antimicrobial therapy
Co-trimoxazole OR doxycycline
  • 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 42 months
Other
Standard of care
Standard of care for patients with IPF for comparison
  • Other: No Intervention: Standard of Care
    Standard of care

Recruiting Locations

Trials Today and nearby locations

University of Cincinnati
Cincinnati, Ohio 45267
Contact:
Nishant Gupta, MD, MS
513-558-4858
nishant.gupta@uc.edu

Ohio State
Columbus, Ohio 43221
Contact:
Nitin Bhatt, MD
nitin.bhatt@osumc.edu

Mayo Clinic
Rochester, New York 55905
Contact:
Moua Teng, MD
moua.teng@mayo.edu

University of Rochester
Rochester, New York 14642
Contact:
Matt Kottmann, MD
585-275-4861
matt_kottmann@urmc.rochester.edu

Columbia University
New York, New York 10032
Contact:
David Lederer, MD, MS
212-305-8203
dl427@cumc.columbia.edu

Weill Cornell Medicine
New York, New York 10065
Contact:
Robert Kaner, MD
646-962-2333
rkaner@med.cornell.edu

Pennsylvania State University
Hershey, Pennsylvania 17033
Contact:
Rebecca Bascom, MD, MPH
717-531-6526
rbascom@pennstatehealth.psu.edu

Temple University
Philadelphia, Pennsylvania 19122
Contact:
Gerard Criner, MD
215-707-8113
Gerard.Criner@tuhs.temple.edu

INOVA
Falls Church, Virginia 22042
Contact:
Christopher King, MD
703-953-7837
christopher.king@inova.org

Washington University
Seattle, Washington 98195
Contact:
Ganesh Raghu, MD
206-598-0440
graghu@uw.edu

University of Virginia
Charlottesville, Virginia 22908
Contact:
Imre Noth, MD
434-297-7737
in2c@hscmail.mcc.virginia.edu

University of Utah
Salt Lake City, Utah 84108
Contact:
Mary Beth Scholand, MD
801-581-5864
scholand@genetics.utah.edu

Vanderbilt
Nashville, Tennessee 37232
Contact:
Lisa Lancaster, MD
615-343-7068
lisa.lancaster@vanderbilt.edu

University of Texas at San Antonio
San Antonio, Texas 78229
Contact:
Anoop Nambiar, MD, MS
210-567-6267
nambiar@uthscsa.edu

Albany Medical College
Albany, New York 12208
Contact:
Beegle Scott, MD
BeegleS@mail.amc.edu

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
Contact:
Rick Enelow, MD
603-650-5533
Richard.I.Enelow@dartmouth.edu

Northwestern University
Chicago, Illinois 60611
Contact:
Sangeeta Bhorade, MD
312-695-4015
sbhorade@nm.org

University of Chicago
Chicago, Illinois 60637
Contact:
Mary Strek, MD
773-702-1796
mstrek@medicine.bsd.uchicago.edu

Loyola University Chicago
Chicago, Illinois 60153
Contact:
Dan Dilling, MD, FACP
708-216-5404
ddillin@lumc.edu

Stanford
Stanford, California 94305
Contact:
Rishi Raj, MD
650-497-2929
Rishi.Raj@stanford.edu

University of Arizona
Tucson, Arizona 85724
Contact:
Sachin Chaudhary, MD
989-980-3228
sachin@deptofmed.arizona.edu

University of California David Medical Center
Sacramento, California 95817
Contact:
Justin Oldham, MD
916-871-1522
joldham@ucdavis.edu

University of Kansas
Kansas City, Kansas 66160
Contact:
Mark Hamblin, MD
913-588-6045
mhamblin@kucm.edu

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Leo Ginns, MD
617-726-1718
Ginns.Leo@mgh.harvard.edu

Spectrum Health
Grand Rapids, Michigan 49503
Contact:
Shelley Schmidt, MD
616-267-8244
shelley.schmidt@spectrumhealth.org

University of Minnesota
Minneapolis, Minnesota 55455
Contact:
Hyun Kim, MD
612-624-0999
kimxx015@umn.edu

University of Michigan
Ann Arbor, Michigan 48109
Contact:
Beth Belloli, MD
734-615-8383
bellolie@med.umich.edu

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Contact:
Joe Zibrak, MD
617-667-5864
jzibrak@bidmc.harvard.edu

Brigham and Women's Hospital
Boston, Massachusetts 02115
Contact:
Hilary Goldberg, MD
617-732-7420
hjgoldberg@bwh.harvard.edu

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Tracy Luckhardt, MD
205-975-6770
tluckhardt@uabmc.edu

More Details

NCT ID
NCT02759120
Status
Recruiting
Sponsor
Weill Medical College of Cornell University

Study Contact

Fernando Martinez, MD, MS
212-746-6420
fjm2003@med.cornell.edu

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.