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

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ClinicalTrials.gov Identifier: NCT02759120
Recruitment Status : Terminated (Terminated for futility after review of first planned interim analysis.)
First Posted : May 3, 2016
Results First Posted : March 3, 2021
Last Update Posted : April 8, 2021
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 : 513 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
Actual Primary Completion Date : March 16, 2020
Actual Study Completion Date : March 16, 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. Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality [ Time Frame: Randomization to up to 35 months ]

Secondary Outcome Measures :
  1. Number of Participants With Death From Any Cause [ Time Frame: Randomization to up to 35 months ]
  2. Number of Participants With First Non-elective, Respiratory Hospitalization [ Time Frame: Randomization to up to 35 months ]
  3. Number of Participants With First Non-elective, All-cause Hospitalization [ Time Frame: Randomization to up to 35 months ]
  4. Total Number of Non-elective Respiratory Hospitalizations [ Time Frame: Randomization to up to 35 months ]
  5. Total Number of Non-elective All-cause Hospitalizations [ Time Frame: Randomization to up to 35 months ]
  6. Percent Change in Forced Vital Capacity (FVC) [ Time Frame: Randomization to 12 months ]
  7. Percent Change in Diffusion Capacity of Lungs for Carbon Monoxide (DLCO) [ Time Frame: Randomization to 12 months ]
  8. Total Number of Respiratory Infections [ Time Frame: Randomization to up to 35 months ]
  9. Change in UCSD-Shortness of Breath Questionnaire [ Time Frame: Randomization to 12 months ]
    Change in University of California San Diego (UCSD) Shortness of Breath Questionnaire (0 - 120 range). A lower score indicates a better health score. The UCSD-Shortness of Breath Questionnaire assesses the severity of shortness of breath during specific activities of daily living.

  10. Change in Fatigue Severity Scale Score [ Time Frame: Randomization to 12 months ]
    Fatigue Severity Scale score (1 - 7 range). A lower score indicates a better health score. The Fatigue Severity Scale measures the severity of fatigue and its effect on a person's activities and lifestyle.

  11. Change in Leicester Cough Questionnaire Score [ Time Frame: Randomization to 12 months ]
    Leicester Cough Questionnaire score (3 - 21 range). A higher score indicates a better health score. The Leicester Cough Questionnaire measures quality of life in people with a chronic cough.

  12. Change in EuroQol Index (EQ-5D) Score [ Time Frame: Randomization to 12 months ]
    European Quality of Life-5 dimensions (EQ-5D) score (0 - 1 range). A higher score indicates a better health score. The EQ-5D measures quality of life across 5 dimensions (1. Mobility, 2. Self-care, 3. Usual activities, 4. Pain/discomfort, 5. Anxiety/depression.

  13. Change in ICEpop CAPability Measure for Older People (ICECAP-O) Score [ Time Frame: Randomization to 12 months ]
    Change in ICEpop (Investigating Choice Experiments for the Preferences of Older People) CAPability measure for Older people (ICECAP-O) score (0 - 1 range). A lower score indicates a better health score. The ICEpop CAPability measure for Older people (ICECAP-O) is intended for use in economic evaluations of care services for older people.

  14. Change in Short Form-12 Health Survey (SF-12) 6D Score [ Time Frame: Randomization to 12 months ]
    Change in Short Form-12 health survey (SF-12) 6D score (0.29 - 1.00 range). A higher indicates a better health score. The SF-12 6D score provides and economic evaluation.

  15. Change in Short Form-12 Health Survey (SF-12) Physical Score [ Time Frame: Randomization to 12 months ]

    Change in short form-12 health survey (SF-12) physical component summary (PSC) score (0 - 100 range). A higher score indicates a better health score.

    The short form-12 health survey physical score assesses limitations in physical activities because of health problems.


  16. Change in SF-12 Health Survey (SF-12) Mental Score [ Time Frame: Randomization to 12 months ]

    Change in short form-12 health survey (SF-12) mental component summary (MCS) score (0 - 100 range). A higher score indicates a better health score.

    The short form-12 health survey (SF-12) mental component summary (MCS) assesses general mental health.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Locations
Show 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
  Study Documents (Full-Text)

Documents provided by Weill Medical College of Cornell University:
Statistical Analysis Plan  [PDF] November 28, 2016
Study Protocol  [PDF] March 2, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02759120    
Other Study ID Numbers: 1504016087
U01HL128954 ( U.S. NIH Grant/Contract )
First Posted: May 3, 2016    Key Record Dates
Results First Posted: March 3, 2021
Last Update Posted: April 8, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPD will be uploaded in a de-identified manner into BioLINCC with open access for interested investigators
Supporting Materials: Study Protocol
Statistical Analysis Plan (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
URL: https://biolincc.nhlbi.nih.gov/home/

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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
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Doxycycline
Anti-Bacterial Agents
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Urinary
Renal Agents