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CleanUP IPF for the Pulmonary Trials Cooperative (CleanUp-IPF)

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ClinicalTrials.gov Identifier: NCT02759120
Recruitment Status : Active, not recruiting
First Posted : May 3, 2016
Last Update Posted : September 17, 2019
Sponsor:
Collaborators:
Duke Clinical Research Institute
University of Chicago
University of Washington
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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).

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Antimicrobial therapy: Co-trimoxazole or Doxycycline Other: No Intervention: Standard of Care Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 509 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Clinical Efficacy of Antimicrobial Therapy Strategy Using Pragmatic Design in Idiopathic Pulmonary Fibrosis
Actual Study Start Date : March 22, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
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 36 months

Standard of care
Standard of care for patients with IPF for comparison
Other: No Intervention: Standard of Care
Standard of care




Primary Outcome Measures :
  1. Time to first non-elective, respiratory hospitalization or all-cause mortality [ Time Frame: Randomization to event (up to 42 months) ]
    Days


Secondary Outcome Measures :
  1. Time to death from any cause [ Time Frame: Randomization to event (up to 42 months) ]
    Days

  2. Time to first non-elective, respiratory hospitalization [ Time Frame: Randomization to event (up to 42 months) ]
    Days

  3. Time to first non-elective, all-cause hospitalization [ Time Frame: Randomization to event (up to 42 months) ]
    Days

  4. Total number of non-elective respiratory hospitalizations [ Time Frame: Randomization to event (up to 42 months) ]
    Days

  5. Total number of non-elective all-cause hospitalizations [ Time Frame: Randomization to event (up to 42 months) ]
    Days

  6. % Change in forced vital capacity (FVC) [ Time Frame: Randomization to 12 months ]
    Percent change

  7. % change in diffusion capacity of lungs for carbon monoxide (DLCO) [ Time Frame: Randomization to 12 months ]
    Percent change

  8. Total number of respiratory infections [ Time Frame: Randomization to event (up to 42 months) ]
    Number of respiratory infections

  9. Change in University of California San Diego (UCSD)-Shortness of Breath Questionnaire [ Time Frame: Randomization to 12 months ]
    Difference in score

  10. Change in Fatigue Severity Scale score [ Time Frame: Randomization to 12 months ]
    Difference in score

  11. Change in Leicester Cough Questionnaire score [ Time Frame: Randomization to 12 months ]
    Difference in score

  12. Change in European Quality of Life-5 dimensions (EQ-5D) score [ Time Frame: Randomization to 12 months ]
    Difference in score

  13. Change in short form-12 health survey (SF-12) score [ Time Frame: Randomization to 12 months ]
    Difference in score

  14. Change in ICEpop (Investigating Choice Experiments for the Preferences of Older People) CAPability measure for Older people (ICECAP-O) score [ Time Frame: Randomization to 12 months ]
    Difference in score



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02759120


  Show 31 Study Locations
Sponsors and Collaborators
Weill Medical College of Cornell University
Duke Clinical Research Institute
University of Chicago
University of Washington
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Fernando Martinez, MD, MS Weill Cornell Medical Medicine

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02759120     History of Changes
Other Study ID Numbers: 1504016087
U01HL128954 ( U.S. NIH Grant/Contract )
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Weill Medical College of Cornell University:
Idiopathic Pulmonary Fibrosis
IPF
pulmonary fibrosis
antimicrobial therapy
doxycycline
co-trimoxazole
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Doxycycline
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Urinary
Renal Agents