Trial Search Results

CleanUP IPF for the Pulmonary Trials Cooperative

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).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Weill Medical College of Cornell University

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Stanford Investigator(s):

Intervention(s):

  • Drug: Antimicrobial therapy: Co-trimoxazole or Doxycycline
  • Other: No Intervention: Standard of Care

Phase:

Phase 3

Eligibility


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.

Ages Eligible for Study

40 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting