Summary

for people ages 40 years and up (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

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).

Official Title

Study of Clinical Efficacy of Antimicrobial Therapy Strategy Using Pragmatic Design in Idiopathic Pulmonary Fibrosis

Details

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.

Keywords

Idiopathic Pulmonary Fibrosis IPF pulmonary fibrosis antimicrobial therapy doxycycline co-trimoxazole Fibrosis Idiopathic Interstitial Pneumonias Trimethoprim, Sulfamethoxazole Drug Combination Anti-Infective Agents Anti-Bacterial Agents Antimicrobial therapy: Co-trimoxazole or Doxycycline

Eligibility

You can join if…

Open to people ages 40 years and up

  1. ≥ 40 years of age
  2. Diagnosed with idiopathic pulmonary fibrosis (IPF) by enrolling investigator
  3. Signed informed consent

You CAN'T join if...

  1. Received antimicrobial therapy in the past 30 days
  2. Contraindicated for antibiotic therapy, including but not exclusive to:
  3. Allergy or intolerance to both tetracyclines AND trimethoprim, sulfonamides or their combination
  4. Allergy or intolerance to tetracyclines AND known potassium level > 5 mEq/L in the past 90 days.
  5. If the enrolling physician feels the potassium level has normalized, documentation to that effect must be provided.
  6. 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
  7. Allergy or intolerance to tetracyclines AND known glucose-6-phosphate dehydrogenase deficiency
  8. Allergy or intolerance to tetracyclines AND untreated folate or B12 deficiency
  9. Allergy or intolerance to tetracyclines AND known renal insufficiency (defined as a glomerular filtration rate (GFR) < 30 ml within the previous 90 days)
  10. If the enrolling physician feels the renal dysfunction has resolved, documentation to that effect must be provided.
  11. Pregnant or anticipate becoming pregnant
  12. 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.
  13. Concomitant immunosuppression with azathioprine, mycophenolate, cyclophosphamide, or cyclosporine.

Locations

  • University of California David Medical Center accepting new patients
    Sacramento California 95817 United States
  • Stanford accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Weill Medical College of Cornell University
Links
Sign up for this study
ID
NCT02759120
Phase
Phase 3
Study Type
Interventional
Last Updated