CleanUP IPF for the Pulmonary Trials Cooperative
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Antimicrobial therapy: Co-trimoxazole or Doxycycline; No Intervention: Standard of Care
Intervention description: 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
Intervention MeSH terms: Doxycycline; Anti-Bacterial Agents; Trimethoprim, Sulfamethoxazole Drug Combination; Anti-Infective Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 513.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Idiopathic Pulmonary Fibrosis; IPF; pulmonary fibrosis; antimicrobial therapy; doxycycline; co-trimoxazole

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).
    

Eligibility 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.