Please select the eligibility criteria that correspond to the clinical trial below.
Title: Micafungin Versus Placebo in the Nosocomial Sepsis in Patients Multi-colonized With Candida, Randomized Controlled Trial
Brief Summary: Invasive Candida infections are burdened with a high mortality rate and is very common in intensive care units. This study aims to evaluate the efficacy of empirical treatment with micafungin in adult patients with suspected invasive candidiasis.


Options:
A: 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.
B: Inclusion Criteria:

* Age ≥ 18 years
* Persistent sepsis without documented invasive candidiasis:

systemic inflammatory response syndrome (SIRS) presence of two signs on the 4 \[temperature \<36 ° C or\> 38 ° C, heart rate\> 90/min, respiratory rate\> 20/min or PaCO2 \<32 mmHg, leukocytosis\> 12,000 / mm3, \<4.000/mm3 or presence of circulating immature forms (\> 10% of cells)\] mechanical ventilation (intubation or tracheostomy) for over 4 days (96 hours) central line use of broad-spectrum antibacterial for more than 4 calendar days (96 hours) in the previous week presence of at least one extra-digestive site colonized by Candida sp. (Urine, mouth, throat, upper and lower respiratory tract, skin folds, and suction drains after surgery ...), not lower digestive tract, are not taken into account the positive samples of rectal swabs and / or stool cultures, absence of proven bacterial infections untreated no evidence of invasive fungal infections (positive blood culture, positive culture of a surgical site, deep biopsy with fungal) infection or mold according to the criteria of the group "fungal infection of the EORTC" organ failure

* Hospitalization in intensive care for over 5 days (120 hours)
* Giving a free, informed and in writing. In the absence of the person of trust or a family member (if present)consent to emergency possible.
* Receiving a social security system,
* Negative pregnancy test for patients of childbearing age

Exclusion Criteria:

* Proven invasive fungal infection (positive blood culture, positive culture of a surgical site, deep biopsy with fungal infection), including aspergillosis requiring antifungal therapy at the time of randomization
* Prognosis of less than 48 hours (for which the patient outcome will be fatal whatever treatment),
* Echinocandin antifungal treatment by more than one day or another antifungal for over 72 hours in the week before the inclusion visit,
* Allergy, hypersensitivity or known intolerance to echinocandins antifungal or any of the excipients of the drug
* Neutropenia (ANC \<500/mm3)
* History of organ and bone marrow,
* Recent chemotherapy (less than 6 months)
* Systemic immunosuppressive therapy in progress, other than with corticosteroids at doses below 2 mg / kg / day of prednisolone or equivalent
* Participation in another interventional study in the same ICU stay or making treatment being evaluated within 28 days prior to randomization
* Any clinical investigator deems incompatible with the conduct of the study in acceptable security conditions
* Pregnant and lactating women,
* Adults subject to a legal protection measure
* Persons deprived of their liberty by a judicial or administrative decision, those hospitalized without consent, persons admitted to a health facility or social purposes other than research
C: Inclusion Criteria:

* surgical patients admitted to our ICU older than 18 years of age and expected to require invasive mechanical ventilation for more than 48 h.

Exclusion Criteria:

* pregnancy,
* proven Candida infection,
* prophylactic or curative antifungal treatment within the last 2 months,
* contraindication to oral drug administration,
* known allergy to nystatin or its derivatives, and prior inclusion in the study
D: Inclusion Criteria:

* Non-pregnant \>18 yrs of age
* Subjects admitted to ICU during the preceding 3 days and expected to stay in the ICU for at least another 48 hours.Subjects can be enrolled on days 3-5 of ICU admission.
* Subjects meeting the clinical prediction rule

Exclusion Criteria:

* Subjects with an allergy/intolerance to caspofungin or echinocandin analog
* absolute neutrophil count \<500/mm3 at study entry or likely to develop such a count during therapy
* acquired immunodeficiency syndrome, aplastic anemia or chronic granulomatous disease
* moderate or severe hepatic insufficiency
* subjects who are pregnant or lactating
* unlikely to survive \< 24 hours
* subjects who have received systemic antifungal therapy within 10 days prior to study entry
* Documented active proven or probable invasive fungal infection upon enrollment
* previously enrolled in this study
* Currently on another investigational agent or have received an investigational agent within 10 days prior to study entry.

Answer: B