CleanUP IPF for the Pulmonary Trials Cooperative



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:1/23/2019
Start Date:March 22, 2017
End Date:July 2019
Contact:Fernando Martinez, MD, MS
Email:fjm2003@med.cornell.edu
Phone:212-746-6420

Use our guide to learn which trials are right for you!

Study of Clinical Efficacy of Antimicrobial Therapy Strategy Using Pragmatic Design in Idiopathic Pulmonary Fibrosis

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).

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.

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:

1. Allergy or intolerance to both tetracyclines AND trimethoprim, sulfonamides or
their combination

2. 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.

3. Pregnant or anticipate becoming pregnant

4. 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.

5. Concomitant immunosuppression with azathioprine, mycophenolate, cyclophosphamide, or
cyclosporine.
We found this trial at
31
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-667-5864
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-975-6770
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-1718
?
mi
from
Boston, MA
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-732-7420
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Phone: 773-702-1796
University of Chicago One of the world's premier academic and research institutions, the University of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
(612) 625-5000
Phone: 612-624-0999
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
116th St and Broadway
New York, New York 10027
(212) 854-1754
Phone: 212-305-8203
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
?
mi
from
New York, NY
Click here to add this to my saved trials
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Phone: 585-275-4861
University of Rochester The University of Rochester is one of the country's top-tier research universities....
?
mi
from
Rochester, NY
Click here to add this to my saved trials
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Phone: 801-581-5864
University of Utah Research is a major component in the life of the U benefiting...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Stanford, California 94304
Phone: 650-497-2929
?
mi
from
Stanford, CA
Click here to add this to my saved trials
47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
?
mi
from
Albany, NY
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-615-8383
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Charlottesville, Virginia 22903
(434) 924-0311
Phone: 434-297-7737
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
Phone: 312-695-4015
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1200 West Loyola Avenue
Chicago, Illinois 60626
Phone: 708-216-5404
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Phone: 513-558-4858
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Columbus, Ohio 43210
?
mi
from
Columbus, OH
Click here to add this to my saved trials
6565 Arlington Boulevard
Falls Church, Virginia 60637
Phone: 703-953-7837
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
Phone: 616-267-8244
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Hershey, Pennsylvania 17033
Phone: 717-531-6526
?
mi
from
Hershey, PA
Click here to add this to my saved trials
Kansas City, Kansas
Phone: 913-588-6045
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Phone: 603-650-5533
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Nashville, Tennessee 37212
Phone: 615-343-7068
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New York, New York 10065
Phone: 646-962-2333
?
mi
from
New York, NY
Click here to add this to my saved trials
1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Phone: 215-707-8113
Temple University Temple University is many things to many people. A place to pursue life's...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Rochester, New York 55905
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Sacramento, California 95817
Phone: 916-871-1522
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
San Antonio, Texas 78249
Phone: 210-567-6267
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Seattle, Washington 98104
Phone: 206-598-0440
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Tucson, Arizona 85721
(520) 621-2211
Phone: 989-980-3228
University of Arizona The University of Arizona is a premier, public research university. Established in...
?
mi
from
Tucson, AZ
Click here to add this to my saved trials