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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 28, 2016
First Posted Date  ICMJE May 3, 2016
Last Update Posted Date September 17, 2019
Actual Study Start Date  ICMJE March 22, 2017
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2017)
Time to first non-elective, respiratory hospitalization or all-cause mortality [ Time Frame: Randomization to event (up to 42 months) ]
Days
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2016)
Time to first non-elective, respiratory hospitalization or all-cause mortality [ Time Frame: Randomization to event (up to 42 months) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2017)
  • Time to death from any cause [ Time Frame: Randomization to event (up to 42 months) ]
    Days
  • Time to first non-elective, respiratory hospitalization [ Time Frame: Randomization to event (up to 42 months) ]
    Days
  • Time to first non-elective, all-cause hospitalization [ Time Frame: Randomization to event (up to 42 months) ]
    Days
  • Total number of non-elective respiratory hospitalizations [ Time Frame: Randomization to event (up to 42 months) ]
    Days
  • Total number of non-elective all-cause hospitalizations [ Time Frame: Randomization to event (up to 42 months) ]
    Days
  • % Change in forced vital capacity (FVC) [ Time Frame: Randomization to 12 months ]
    Percent change
  • % change in diffusion capacity of lungs for carbon monoxide (DLCO) [ Time Frame: Randomization to 12 months ]
    Percent change
  • Total number of respiratory infections [ Time Frame: Randomization to event (up to 42 months) ]
    Number of respiratory infections
  • Change in University of California San Diego (UCSD)-Shortness of Breath Questionnaire [ Time Frame: Randomization to 12 months ]
    Difference in score
  • Change in Fatigue Severity Scale score [ Time Frame: Randomization to 12 months ]
    Difference in score
  • Change in Leicester Cough Questionnaire score [ Time Frame: Randomization to 12 months ]
    Difference in score
  • Change in European Quality of Life-5 dimensions (EQ-5D) score [ Time Frame: Randomization to 12 months ]
    Difference in score
  • Change in short form-12 health survey (SF-12) score [ Time Frame: Randomization to 12 months ]
    Difference in score
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2016)
  • Time to death from any cause [ Time Frame: Randomization to event (up to 42 months) ]
  • Time to first non-elective, respiratory hospitalization [ Time Frame: Randomization to event (up to 42 months) ]
  • Time to first non-elective, all-cause hospitalization [ Time Frame: Randomization to event (up to 42 months) ]
  • Total number of non-elective respiratory hospitalizations [ Time Frame: Randomization to event (up to 42 months) ]
  • Total number of non-elective all-cause hospitalizations [ Time Frame: Randomization to event (up to 42 months) ]
  • % Change in forced vital capacity (FVC) [ Time Frame: Randomization to 12 months ]
  • % change in diffusion capacity of lungs for carbon monoxide (DLCO) [ Time Frame: Randomization to 12 months ]
  • Total number of respiratory infections [ Time Frame: Randomization to event (up to 42 months) ]
  • Change in Univeristy of California San Diego (UCSD)-Shortness of Breath Questionnaire [ Time Frame: Randomization to 12 months ]
  • Change in Fatigue Severity Scale score [ Time Frame: Randomization to 12 months ]
  • Change in Leicester Cough Questionnaire score [ Time Frame: Randomization to 12 months ]
  • Change in European Quality of Life-5 dimensions (EQ-5D) score [ Time Frame: Randomization to 12 months ]
  • Change in short form-12 health survey (SF-12) score [ Time Frame: Randomization to 12 months ]
  • Change in ICEpop CAPability measure for Older people (ICECAP-O) score [ Time Frame: Randomization to 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CleanUP IPF for the Pulmonary Trials Cooperative
Official Title  ICMJE Study of Clinical Efficacy of Antimicrobial Therapy Strategy Using Pragmatic Design in Idiopathic Pulmonary Fibrosis
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE
  • 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
  • Other: No Intervention: Standard of Care
    Standard of care
Study Arms  ICMJE
  • Experimental: Antimicrobial therapy
    Co-trimoxazole OR doxycycline
    Intervention: Drug: Antimicrobial therapy: Co-trimoxazole or Doxycycline
  • Standard of care
    Standard of care for patients with IPF for comparison
    Intervention: Other: No Intervention: Standard of Care
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 12, 2019)
509
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2016)
500
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02759120
Other Study ID Numbers  ICMJE 1504016087
U01HL128954 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE
  • Duke Clinical Research Institute
  • University of Chicago
  • University of Washington
  • University of Pittsburgh
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Fernando Martinez, MD, MS Weill Cornell Medical Medicine
PRS Account Weill Medical College of Cornell University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP