Overview

CleanUP IPF for the Pulmonary Trials Cooperative

Status:
Terminated
Trial end date:
2020-03-16
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Weill Medical College of Cornell University
Collaborators:
Duke Clinical Research Institute
National Heart, Lung, and Blood Institute (NHLBI)
University of Chicago
University of Pittsburgh
University of Washington
Treatments:
Anti-Bacterial Agents
Anti-Infective Agents
Doxycycline
Trimethoprim, Sulfamethoxazole Drug Combination
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.