CleanUP IPF for the Pulmonary Trials Cooperative

Overview

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 (ACEI), angiotensin II receptor blockers (ARB), or potassium sparing diuretic
    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/min 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.
  5. Concomitant immunosuppression with azathioprine, mycophenolate, cyclophosphamide, or cyclosporine.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Teng Moua, M.D.

Closed for enrollment

Contact information:

Pulmonary Clinical Research Unit

(800) 753-1606

PCRUE18@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20317438

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