CleanUP IPF for the Pulmonary Trials Cooperative

NCT02759120 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: 1504016087U01HL128954
• Study Type: interventional
• Target: 513
• Locations: 1 country
• Sites: 31

Brief Summary

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).

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis; IPF; pulmonary fibrosis; antimicrobial therapy; doxycycline; co-trimoxazole

Outcome Measures

Primary Outcomes (1)

• Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality

  Randomization to up to 35 months

Secondary Outcomes (16)

• Number of Participants With Death From Any Cause

  Randomization to up to 35 months

• Number of Participants With First Non-elective, Respiratory Hospitalization

  Randomization to up to 35 months

• Number of Participants With First Non-elective, All-cause Hospitalization

  Randomization to up to 35 months

• Total Number of Non-elective Respiratory Hospitalizations

  Randomization to up to 35 months

• Total Number of Non-elective All-cause Hospitalizations

  Randomization to up to 35 months

Study Arms (2)

Antimicrobial therapy

EXPERIMENTAL

Co-trimoxazole OR doxycycline

Drug: Antimicrobial therapy: Co-trimoxazole or Doxycycline

Standard of care

OTHER

Standard of care for patients with IPF for comparison

Other: No Intervention: Standard of Care

Interventions

Antimicrobial therapy: Co-trimoxazole or Doxycycline DRUG

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 36 months

Antimicrobial therapy

No Intervention: Standard of Care OTHER

Standard of care

Standard of care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 40 years of age
• Diagnosed with idiopathic pulmonary fibrosis (IPF) by enrolling investigator
• Signed informed consent

You may not qualify if:

• Received antimicrobial therapy in the past 30 days
• 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.
• 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
• Allergy or intolerance to tetracyclines AND known glucose-6-phosphate dehydrogenase deficiency
• Allergy or intolerance to tetracyclines AND untreated folate or B12 deficiency
• 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.
• Pregnant or anticipate becoming pregnant
• 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.
• Concomitant immunosuppression with azathioprine, mycophenolate, cyclophosphamide, or cyclosporine.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Duke Clinical Research Institute: collaborator
• University of Chicago: collaborator
• University of Washington: collaborator
• University of Pittsburgh: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (31)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Stanford

Stanford, California, 94305, United States

Location

Loyola University Chicago

Chicago, Illinois, 60153, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Mayo Clinic

Rochester, New York, 55905, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State

Columbus, Ohio, 43221, United States

Location

Pennsylvania State University

Hershey, Pennsylvania, 17033, United States

Location

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

Vanderbilt

Nashville, Tennessee, 37232, United States

Location

University of Texas at San Antonio

San Antonio, Texas, 78229, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

INOVA

Falls Church, Virginia, 22042, United States

Location

Washington University

Seattle, Washington, 98195, United States

Location

Related Publications (3)

• Kim JS, Murray S, Yow E, Anstrom KJ, Kim HJ, Flaherty KR, Martinez FJ, Noth I. Comparison of Pirfenidone and Nintedanib: Post Hoc Analysis of the CleanUP-IPF Study. Chest. 2024 May;165(5):1163-1173. doi: 10.1016/j.chest.2023.11.035. Epub 2023 Nov 27.

  PMID: 38030064 DERIVED

• Martinez FJ, Yow E, Flaherty KR, Snyder LD, Durheim MT, Wisniewski SR, Sciurba FC, Raghu G, Brooks MM, Kim DY, Dilling DF, Criner GJ, Kim H, Belloli EA, Nambiar AM, Scholand MB, Anstrom KJ, Noth I; CleanUP-IPF Investigators of the Pulmonary Trials Cooperative. Effect of Antimicrobial Therapy on Respiratory Hospitalization or Death in Adults With Idiopathic Pulmonary Fibrosis: The CleanUP-IPF Randomized Clinical Trial. JAMA. 2021 May 11;325(18):1841-1851. doi: 10.1001/jama.2021.4956.

  PMID: 33974018 DERIVED

• Anstrom KJ, Noth I, Flaherty KR, Edwards RH, Albright J, Baucom A, Brooks M, Clark AB, Clausen ES, Durheim MT, Kim DY, Kirchner J, Oldham JM, Snyder LD, Wilson AM, Wisniewski SR, Yow E, Martinez FJ; CleanUP-IPF Study Team. Design and rationale of a multi-center, pragmatic, open-label randomized trial of antimicrobial therapy - the study of clinical efficacy of antimicrobial therapy strategy using pragmatic design in Idiopathic Pulmonary Fibrosis (CleanUP-IPF) clinical trial. Respir Res. 2020 Mar 12;21(1):68. doi: 10.1186/s12931-020-1326-1.

  PMID: 32164673 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Elizabeth Peters
• Organization: Weill Cornell Medicine

elp2018@med.cornell.edu

646-962-2742

Study Officials

• Fernando Martinez, MD, MS

  Weill Cornell Medical Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 3, 2016
• Study Start: March 22, 2017
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: April 8, 2021
• Results First Posted: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within a year of the primary paper publication and then indefinitely maintained by BioLINCC
• Access Criteria: The data will be open access for interested investigators

Locations

US (31)