Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase III of Recombinant Human Activated Protein C and Low Dose of Hydrocortisone and Fludrocortisone in Adult Septic Shock
Brief Summary: This study aims at comparing the efficacy and safety of recombinant human activated protein C to that of low dose of corticosteroids and at investigating the interaction between these drugs in the management of septic shock


Options:
A: Inclusion Criteria:

* hospitalized in intensive care unit for less than 7 days
* septic shock for less than 24 hours
* at least one proven site of infection
* at least 2 organ dysfunction as defined by a SOFA score =or\> to 3 for at least 6 consecutive hours
* need for vasopressor (dopamine =or\>15µg/kg/min or epinephrine/norepinephrine at =or\>0,25 µg/kg/min for at least 6 consecutive hours, to maintain systolic arterial pressure at 90 mmHg or more OR mean arterial pressure at 6( mmHg or more
* informed consent

Exclusion Criteria:

* pregnancy or breath feeding
* decision not to resuscitate
* underlying disease with an estimated life expectancy of less than 1 month
* formal indication for corticosteroids
* recent surgery (ie within the past 72 hours) or a surgery at high risk of bleeding
* gastro-intestinal bleeding within the past 6 weeks
* chronic liver disease (Child C)
* recent trauma (ie within the past 72 hours)
* intracranial process
* history of stroke, CNS bleeding or traumatic brain injury within the past 3 months
* platelet counts of less than 30000 per cubic millimeter
* formal indication for curative anticoagulant; prophylactic use of heparin is allowed
* any condition of high risk of bleeding as per patient's primary physicians
* hypersensitivity of activated drotrecogin alpha or any other component of the drug
* no affiliation to a social security

Amendments to eligibility criteria were:

On 27/03/2008: Changes in following exclusion criteria :

* "surgical procedure in the past 7 days" was changed for "surgical procedure within 72 hours, or any surgery associated with high risk of bleeding, or a planned surgery within 24 h".
* "chronic liver disease" was clarified as "chronic liver disease with Child score C".
* "severe thrombopenia" was clarified "as severe thrombopenia (\<30,000/mm3, before transfusion).

On 25/08/2009: The exclusion criteria: surgical procedure within 72 hours, or any surgery associated with high risk of bleeding, or a planned surgery within 24 h" was changed for "surgical procedure within 12 hours, or any surgery associated with high risk of bleeding

On 11/06/2010: the inclusion criteria: admitted to the ICU for \< 7 days was removed; and a new exclusion criteria was added: "patients who had a previous episode of sepsis during the same hospital stay

On 18/04/2012: following the withdrawal of DAA from the market: the following exclusion criteria (only related to DAA) were removed :

1. any surgery in the past 12 hours, or any surgery associated with high risk of bleeding;
2. chronic liver disease with a Child score C;
3. recent trauma;
4. any intracranial mass, or stroke or head injury in the past 3 months;
5. severe thrombocytopenia (\< 30.000 /mm3, before platelet transfusion);
6. formal indication for anticoagulation, or any other condition associated with increased risk of bleeding, as appreciated by the patient's physician.
B: Inclusion Criteria:

* Severe community-acquired pneumonia Fine V
* CRP \>=15 mg/100 mL

Exclusion Criteria:

* Major contraindications for corticosteroids, such as uncontrolled diabetes, immunosuppression
* Previous glucocorticoid treatment during the previous month
* Documented extrapulmonary infection
* Previous hospitalization in the previous month
C: Inclusion Criteria:

1. Patients 18 years of age or older admitted for hospitalization from the community or a nursing home with CAP.
2. CAP will be defined by a new infiltrate on chest radiograph and the presence of one or several of the following acute respiratory signs or symptoms:

   * cough
   * sputum production
   * dyspnea
   * core body temperature \>38.0° C
   * auscultatory findings of abnormal breath sounds and rales
   * leukocyte count \>10 or \<4 x 109 cells L-1 (1)

Exclusion Criteria:

1. Patients or family members unable to give written informed consent, e.g. with severe dementia.
2. Patients with active intravenous drug use.
3. Severe immunosuppression (e.g. patients infected with human immunodeficiency virus infection and a CD4 count below 350 x 109/L, patients on immunosuppressive therapy after solid organ transplantation and neutropenic patients with neutrophil count \< 500 x 109/L and patients under chemotherapy with neutrophils 500-1000 x 109/L with an expected decrease to values \< 500 x 109/L); patients with cystic fibrosis as well as patients with active tuberculosis.
4. Patients with acute burn injury
5. Patients with acute gastrointestinal bleeding within 3 months of the current hospitalization
6. Patients with an acute concomitant condition requiring more than 0.5mg/kg/d prednisone equivalent
7. Pregnancy or breast feeding
8. Patients with known adrenal insufficiency
D: Inclusion Criteria:

* males and females,
* between 18 and 75 year old
* who present a burned surface more than 30% of the body surface
* who need catecholamine infusion
* between J0 and J3 after the injury.

Exclusion Criteria:

* pregnancy,
* trauma,
* sepsis,
* cardiac insufficiency,
* AIDS,
* etomidate administration

Answer: A