Please select the eligibility criteria that correspond to the clinical trial below.
Title: Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis
Brief Summary: The purposes of this study are to determine:

1. Whether drotrecogin alfa (activated) helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa (activated).
2. Whether drotrecogin alfa (activated) minimizes long term disabilities associated with severe sepsis.
3. The side effects that might be associated with drotrecogin alfa (activated) administration to children with severe sepsis.


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:

* Suspected or proven acute infection.
* Abnormally high or low core body temperature
* Cardiovascular dysfunction which requires the use of vasoactive drugs (such as, dopamine, dobutamine, epinephrine) and is the result of severe sepsis.
* Respiratory dysfunction which requires the use of mechanical ventilation and is the result of severe sepsis.

Exclusion Criteria:

* Patients at increased risk of bleeding.
* Patients at high risk for an intracranial bleed.
* Patients who have undergone a bone marrow transplant.
* Patients with end-stage renal disease.
* Patients whose family or primary care physician is unwilling to allow transfusion of blood products.
C: Inclusion Criteria

* Adults greater than or equal to 18 years of age
* Receiving inpatient treatment for severe sepsis
* Indicated for treatment with Drotrecogin Alfa (Activated) under approved label in the country where the patient is enrolled

Exclusion Criteria

* Contraindicated for heparin treatment
* Require a higher dose of heparin than defined in the trial
* Have acute or chronic renal failure with an estimated creatinine clearance less than 30mL/min
* Weigh more than 135 kg (297 pounds)
* Are not expected to survive 28 days given their medical condition.
D: Inclusion Criteria:

* Must be 18 years or older
* Must have evidence of infection
* Must have systemic inflammatory response syndrome (SIRS)
* Must have vasopressor-dependent septic shock

Exclusion Criteria:

* Have received vasopressor therapy (at any dose) for greater than 24 hours prior to the start of study drug
* Have sepsis-induced organ dysfunction for greater than 36 hours prior to the start of the study drug infusion
* Have single organ dysfunction and recent surgery (within 30 days of study entry)
* Have had surgery performed within the 12-hour period immediately preceding the study drug infusion, or are postoperative with evidence of active bleeding, or have planned or anticipated surgery during the infusion period
* Are not expected to survive 28 days given their preexisting uncorrectable medical condition

Answer: B