Candida in the Respiratory Tract Secretions of Critically Ill Patients and The Efficacy of Antifungal Treatment

• Status: Terminated
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daren K. Heyland
• Collaborators: Pfizer; Queen's University; The Physicians' Services Incorporated Foundation
• Treatments: Anidulafungin; Antifungal Agents; Miconazole

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.