Early Fluconazole Treatment for Coccidiodomycosis Pneumonia

Overview

  • Study type

    Interventional
  • Study phase

    IV
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 15-007551
    NCT ID: NCT02663674
    Sponsor Protocol Number: 14-0053

About this study

This is a Phase IV randomized, double-blinded, placebo-controlled study in 1000 individuals aged 18 years or older, with community acquired pneumonia (CAP) who meet all eligibility criteria in endemic regions. This study is designed to provide data on the effectiveness of early antifungal treatment (Fluconazole, 400 mg/day) for coccidioidomycosis pneumonia (also referred to as Valley Fever (VF) Pneumonia or acute onset valley fever) vs. placebo in subjects with coccidioidomycosis pneumonia. Patients who are prescribed antibacterials by their health care provider for acute CAP will be randomized to receive either placebo or 400 mg/day of fluconazole for 42 days. The primary objective is to assess the clinical response of early empiric antifungal therapy with fluconazole through Day 22 in subjects with coccidioidomycosis pneumonia and are compliant with the study intervention.

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  1. Aged ≥18 years and presenting for clinical care in coccidioidomycosis endemic areas.
  2. Have a health care provider who has decided to treat community acquired pneumonia with antibacterials.
  3. Be able to take and tolerate oral antibacterials/antifungals.
  4. Able to understand the study and provide informed consent.
  5. Willing and able to comply with study procedures and complete study visits.
  6. Willing to allow access to medical record, and medical records are available to the study team.
  7. If enrolled at the same study site at which the diagnosis of CAP was made, the first dosage of study drug will be administered within 36 hours of determination of the need for antibacterials.
  8. If referred from another facility, the screening activities must be completed such that the first dosage of study drug will be administered within 36 hours of discharge from that facility.
  9. Able to swallow large pills.
  10. Sexually active female subjects must be of non-childbearing potential* or, if of childbearing potential, must use a highly effective method of birth control** (captured on the appropriate data collection form) *Non-childbearing potential is defined as being post-menopausal for at least 18 months or surgically sterile via bilateral oophorectomy or hysterectomy.
    1. **Female subjects must avoid becoming pregnant by using one of the following acceptable methods of birth control for 30 days prior to study drug dosing: and must be maintained for 30 days after last dose of study drug
      1. Intrauterine contraceptive device; OR
      2. Oral contraceptives; OR
      3. iImplanon®, Nexplanon®, DepoProvera®, contraceptive skin patch or NuvaRing®; OR
      4. Tubal ligation;

11. Non-pregnant female subjects of childbearing potential must have a negative pregnancy test within 24 hours prior to enrollment and at Visit 03 - Visit 06.

Exclusion Criteria:

  1. Have recently received an experimental agent* or participating in or planning to participate in a study involving an experimental agent** while in the active drug administration phase of this study. * defined as within 30 days prior to enrollment in this study **(e.g., vaccine, drug, biologic device, blood product, or medication)
  2. Present clinical diagnosis of hospital acquired pneumonia (HAP).
  3. Have CAP requiring immediate hospitalization.
  4. Treatment of CAP that requires more than one dose of parenteral antibacterials.
  5. Documented microbiologically- or serologically-confirmed past infection with coccidioidomycosis.
  6. Clinical diagnosis of coccidioidal infection is of sufficient certainty as to exclude antibacterial therapy.
  7. Have a history of systemic antibacterial treatment or systemic antifungal treatment within 30 days of enrollment, other than prescribed as therapy for this CAP episode.
  8. Long term immunosuppressive use* of high dose oral or parenteral glucocorticoids**; or high-dose inhaled steroids***. *defined as taken within 30 days of enrollment **high dose defined as prednisone >/= 20 mg total daily dose, or equivalent dose of other glucocorticoids ***high dose defined as >800 mcg/day of beclomethasone dipropionate or equivalent
  9. Have confirmed or suspected immunosuppression as a result of an underlying illness, (Other than well controlled HIV infections), primary immunodeficiency, or treatment, or induction/maintenance use of immunosuppressive agents*. *including anti-neoplastic chemotherapy for cancer or cytotoxic radiation therapy for cancer, anti-TNF medications, or other parenterally-administered immunomodulating agents
  10. History of a solid organ or bone marrow transplant.
  11. Have poorly controlled HIV-infection* or HIV-infection treated with Lopinavir, Tipranavir, Etravirine or Didanosine. *defined as CD4 < 200 cell/mm3 or detectable HIV viral load within six months of enrollment
  12. Current diagnosis and/or treatment of active liver disease including abnormal baseline liver function tests as defined as: AST greater than or equal to 135 IU/L OR ALT greater than or equal to 150 IU/L OR total bilirubin greater than or equal to 3.0mg/dL.
  13. On hemo or peritoneal dialysis or have a creatinine of > or = 2.0 mg/dL or estimated CrCl < or = 50 mL/min.
  14. History of hypokalemia defined as less than 3.5 mEQ/L on more than one occasion during the last 30 days.
  15. History of cardiovascular disease with increased risk for torsades de pointes as defined as:
    1.  NYHA Heart Failure Criteria III or greater; OR
    2. History of atrial or ventricular dysrhythmias; OR
    3. History of structural heart disease (including previously repaired); OR
    4. Marked prolongation of corrected QT interval (> 450ms ) or prominent T wave inversion on baseline resting 12-lead ECG, as determined by treating provider; OR
    5. Family history of prolonged QT syndrome.
  16. Pregnant or lactating females.
  17. History of azole intolerance or allergy or severe allergic reaction (e.g., anaphylaxis) to Spherusol® or any component of Spherusol® or history of allergic reaction to other coccidioidins. *includes: sodium chloride, sodium borate, phenol and timerosal
  18. Individuals for whom study participation would not be in their best interest, as determined by the clinical investigator.
  19. Are taking medications that may result in clinically significant interactions with fluconazole* will be evaluated by a licensed clinical to determine appropriateness to enroll on a case by case basis
  20. Subjects taking medications that may result in clinically significant interactions with fluconazole will be evaluated for exclusion on individual basis.
  21. Positive point of care HIV test at Day 1 visit consistent with new HIV diagnosis

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Janis Blair, M.D.

Open for enrollment

Contact information:

Michael Burke