Candida in the Respiratory Tract Secretions of Critically Ill Patients and The Efficacy of Antifungal Treatment
Condition: Ventilator Associated Pneumonia; Respiratory Tract Infection
MeSH terms: Pneumonia; Respiratory Tract Infections; Pneumonia, Ventilator-Associated
Intervention: Normal Saline; anidulafungin
Intervention description: Normal Saline; TBA
Intervention MeSH terms: Anidulafungin
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Candida; ventilator associated pneumonia; respiratory tract infection; antifungal; biomarker

Summary:

      The purpose of the study is to determine whether the effect of treating Candida spp. isolated
      in the respiratory tract secretions of patients with a clinical suspicion of ventilator
      associated pneumonia (VAP) on clinical outcomes will be feasible and supported by biomarker
      data obtained.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patients (>18 years old)

          2. In the ICU > 48 hours

          3. Mechanically ventilated (>48 hours)

          4. Grow a Candida spp. on respiratory tract secretion culture (either by Bronchoalveolar
             Lavage or Endotracheal Aspirate) taken on or between 48 hours before or after the day
             of their suspicion of respiratory tract infection.

          5. Develop a clinical suspicion of respiratory tract infection while ventilated as
             defined by the following criteria (as defined previously in our VAP trial)5:

               -  The presence of new, worsening or persistent radiographic features suggestive of
                  pneumonia without another obvious cause AND

               -  The presence of any two of the following:

                    -  Fever > 38C (core temperature)

                    -  Leukocytosis (>11.0 x109/L) or neutropenia (<3.5 x109/L)

                    -  Purulent endotracheal aspirates or change in character of aspirates

                    -  Isolation of pathogenic bacteria from endotracheal aspirates

                    -  Increasing oxygen requirements

        Exclusion Criteria:

          1. Patients not expected to be in ICU for more than 72 hours (due to imminent death,
             withdrawal of aggressive care or discharge).

          2. Patients with Candida spp. in the blood or another sterile body site.

          3. Patients colonized at other non-pulmonary body site(s) with Candida.

          4. Already being treated with antifungal drugs (because of documented fungal infection,
             pre-emptive therapy, or prophylaxis).

          5. Allergy to study drugs (Fluconazole or the Echinocandin on formulary at treating
             institution).

          6. Immunocompromised patients (post-organ transplantation, Acquired Immunodeficiency
             Syndrome [AIDS], neutropenia [<1000 absolute neutrophils], corticosteroids [>20
             mgs/day of prednisone or equivalent for more than 6 months]). These patients are
             excluded since Candida may be more invasive and these patients are much more likely to
             require systemic antifungal therapy.

          7. Patients with fulminant liver failure or end stage liver disease (Child's Class C).

          8. Women who are pregnant or lactating.

          9. Enrollment in industry sponsored interventional trial (co-enrollment in other academic
             studies would be allowed with the proviso that there was no potential interaction
             between the protocols).

         10. Prior randomization in this study.