CleanUP IPF for the Pulmonary Trials Cooperative

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02759120
• Date of registration: 28/04/2016
• Prospective Registration: Yes
• Primary sponsor: Weill Medical College of Cornell University
• Public title: CleanUP IPF for the Pulmonary Trials Cooperative CleanUp-IPF
• Scientific title: Study of Clinical Efficacy of Antimicrobial Therapy Strategy Using Pragmatic Design in Idiopathic Pulmonary Fibrosis
• Date of first enrolment: March 22, 2017
• Target sample size: 509
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02759120
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Fernando Martinez, MD, MS
• Affiliation: Weill Cornell Medical Medicine

Key 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.



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: Antimicrobial therapy: Co-trimoxazole or Doxycycline

Other: No Intervention: Standard of Care

Primary Outcome(s)

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

Secondary Outcome(s)

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

Change in University 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]

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)]

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

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

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

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

Time to first non-elective, all-cause hospitalization [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)]

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

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]

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

Secondary ID(s)

1504016087

U01HL128954

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Chicago

Duke Clinical Research Institute

National Heart, Lung, and Blood Institute (NHLBI)

University of Pittsburgh

University of Washington