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CleanUP IPF for the Pulmonary Trials Cooperative

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

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02759120

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 3

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Weill Medical College of Cornell University

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Fernando Martinez, MD, MS
Principal Investigator Affiliation Weill Cornell Medical Medicine

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherOtherOtherOtherOther
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294

Site Contact

Tracy Luckhardt, MD

tluckhardt@uabmc.edu

205-975-6770

University of Arizona, Tucson, Arizona

Status

Recruiting

Address

University of Arizona

Tucson, Arizona, 85724

Site Contact

Sachin Chaudhary, MD

sachin@deptofmed.arizona.edu

989-980-3228

Sacramento, California

Status

Recruiting

Address

University of California David Medical Center

Sacramento, California, 95817

Site Contact

Justin Oldham, MD

joldham@ucdavis.edu

916-871-1522

Stanford, Stanford, California

Status

Recruiting

Address

Stanford

Stanford, California, 94305

Site Contact

Rishi Raj, MD

Rishi.Raj@stanford.edu

650-497-2929

Loyola University Chicago, Chicago, Illinois

Status

Recruiting

Address

Loyola University Chicago

Chicago, Illinois, 60153

Site Contact

Dan Dilling, MD, FACP

ddillin@lumc.edu

708-216-5404

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

Site Contact

Sangeeta Bhorade, MD

sbhorade@nm.org

312-695-4015

University of Chicago, Chicago, Illinois

Status

Recruiting

Address

University of Chicago

Chicago, Illinois, 60637

Site Contact

Mary Strek, MD

mstrek@medicine.bsd.uchicago.edu

773-702-1796

University of Kansas, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas

Kansas City, Kansas, 66160

Site Contact

Mark Hamblin, MD

mhamblin@kucm.edu

913-588-6045

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Leo Ginns, MD

Ginns.Leo@mgh.harvard.edu

617-726-1718

Brigham and Women's Hospital, Boston, Massachusetts

Status

Recruiting

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Site Contact

Hilary Goldberg, MD

hjgoldberg@bwh.harvard.edu

617-732-7420

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Recruiting

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Site Contact

Joe Zibrak, MD

jzibrak@bidmc.harvard.edu

617-667-5864

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

Beth Belloli, MD

bellolie@med.umich.edu

734-615-8383

Spectrum Health, Grand Rapids, Michigan

Status

Recruiting

Address

Spectrum Health

Grand Rapids, Michigan, 49503

Site Contact

Shelley Schmidt, MD

shelley.schmidt@spectrumhealth.org

616-267-8244

University of Minnesota, Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota

Minneapolis, Minnesota, 55455

Site Contact

Hyun Kim, MD

kimxx015@umn.edu

612-624-0999

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

Site Contact

Rick Enelow, MD

Richard.I.Enelow@dartmouth.edu

603-650-5533

Albany Medical College, Albany, New York

Status

Recruiting

Address

Albany Medical College

Albany, New York, 12208

Site Contact

Beegle Scott, MD

BeegleS@mail.amc.edu

212-746-6420

Columbia University, New York, New York

Status

Recruiting

Address

Columbia University

New York, New York, 10032

Site Contact

David Lederer, MD, MS

dl427@cumc.columbia.edu

212-305-8203

Weill Cornell Medicine, New York, New York

Status

Recruiting

Address

Weill Cornell Medicine

New York, New York, 10065

Site Contact

Robert Kaner, MD

rkaner@med.cornell.edu

646-962-2333

University of Rochester, Rochester, New York

Status

Recruiting

Address

University of Rochester

Rochester, New York, 14642

Site Contact

Matt Kottmann, MD

matt_kottmann@urmc.rochester.edu

585-275-4861

Mayo Clinic, Rochester, New York

Status

Recruiting

Address

Mayo Clinic

Rochester, New York, 55905

Site Contact

Moua Teng, MD

moua.teng@mayo.edu

212-746-6420

University of Cincinnati, Cincinnati, Ohio

Status

Recruiting

Address

University of Cincinnati

Cincinnati, Ohio, 45267

Site Contact

Nishant Gupta, MD, MS

nishant.gupta@uc.edu

513-558-4858

Cleveland Clinic, Cleveland, Ohio

Status

Not yet recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Site Contact

Daniel Culver, DO

212-746-6420

Ohio State, Columbus, Ohio

Status

Recruiting

Address

Ohio State

Columbus, Ohio, 43221

Site Contact

Nitin Bhatt, MD

nitin.bhatt@osumc.edu

212-746-6420

Pennsylvania State University, Hershey, Pennsylvania

Status

Recruiting

Address

Pennsylvania State University

Hershey, Pennsylvania, 17033

Site Contact

Rebecca Bascom, MD, MPH

rbascom@pennstatehealth.psu.edu

717-531-6526

Temple University, Philadelphia, Pennsylvania

Status

Recruiting

Address

Temple University

Philadelphia, Pennsylvania, 19122

Site Contact

Gerard Criner, MD

Gerard.Criner@tuhs.temple.edu

215-707-8113

Vanderbilt, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt

Nashville, Tennessee, 37232

Site Contact

Lisa Lancaster, MD

lisa.lancaster@vanderbilt.edu

615-343-7068

University of Texas at San Antonio, San Antonio, Texas

Status

Recruiting

Address

University of Texas at San Antonio

San Antonio, Texas, 78229

Site Contact

Anoop Nambiar, MD, MS

nambiar@uthscsa.edu

210-567-6267

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah, 84108

Site Contact

Mary Beth Scholand, MD

scholand@genetics.utah.edu

801-581-5864

University of Virginia, Charlottesville, Virginia

Status

Recruiting

Address

University of Virginia

Charlottesville, Virginia, 22908

Site Contact

Imre Noth, MD

in2c@hscmail.mcc.virginia.edu

434-297-7737

INOVA, Falls Church, Virginia

Status

Recruiting

Address

INOVA

Falls Church, Virginia, 22042

Site Contact

Christopher King, MD

christopher.king@inova.org

703-953-7837

Washington University, Seattle, Washington

Status

Recruiting

Address

Washington University

Seattle, Washington, 98195

Site Contact

Ganesh Raghu, MD

graghu@uw.edu

206-598-0440

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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