Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT00934934
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00934934
Study Brief:
Protocol Section:
NCT00934934