Clinical trial NCT00511186 (phase 2, status: terminated)
Conditions: sepsis, bacterial infections and mycoses
ICD codes: A02.1, A22.7, A26.7, A32.7, A42.7, A54.86, B37.7
Drugs: placebo, biap
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][C@]12SC(C)(C)[C@@H](N1C(=O)[C@H]2NC(=O)[C@H](N)C1=CC=CC=C1)C(O)=O
Reason stopped: 
    sufficient poc to switch development from bovine ap to recombinant ap
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients between the age of 18 and 80 years.

          -  Proven or suspected infection.

          -  Two out of four SIRS criteria of systemic inflammation, existing for less than 24
             hours after admission in the intensive care unit, as follows:

               -  Core temperature higher then 38 degree Celsius or lower then 36 degree Celsius.

               -  Heart rate above 90 beats/min (unless the patient has a medical condition known
                  to increase heart rate or is receiving treatment that would prevent tachycardia).

               -  Respiratory rate above 20 breaths/min, a PaCO2 lower then 32mmHg or the use of
                  mechanical ventilation for an acute respiratory process.

               -  White-cell count above 12,000/mm3 or below 4,000/mm3 or a differential count
                  showing >10 percent immature neutrophils.

          -  Acute renal failure, defined as

               -  Rise in serum creatinine level to ≥150μmol/L within the previous 48 hours, in the
                  absence of primary underlying renal disease OR

               -  Minimally a stage 1 Kidney Injury according to AKIN creatinine criteria: Increase
                  in serum creatinine ≥26.2µmol/L (0.3mg/dL) or increase to ≥150% (≥1.5 -fold) from
                  baseline in the previous 48 hours in the absence of primary underlying renal
                  disease and where baseline creatinine is less than 150 µmol/L) OR

               -  Minimally a stage 1 Kidney Injury according to AKIN Urine Output criteria: Urine
                  Output of ≤ 0.5mg/kg/h for ≥6h and following adequate fluid resuscitation when
                  applicable, in the absence of underlying primary renal disease and where baseline
                  creatinine is less than 150µmol/L)

          -  Written informed consent obtained prior to any study intervention.

        Exclusion Criteria:

          -  Pregnant women or nursing mothers and fecund females who are not on effective
             contraception (chemical: pill; or mechanical: IUD)

          -  Patients already on dialysis (RTT) at entry

          -  Known HIV (sero-positive) patients

          -  Patients receiving immunosuppressant therapy or on chronic high doses of steroids
             equivalent to prednisone 1mg/Kg/day

          -  Patients expected to have rapidly fatal disease within 24 hours

          -  Known confirmed gram-positive sepsis

          -  Known confirmed fungal sepsis

          -  Acute pancreatitis with no established source of infection

          -  Patients not expected to survive for 28 days due to other medical conditions such as
             end-stage neoplasm or other diseases

          -  Participation in another investigational study within 90 days prior to start of the
             study which might interfere with this study

          -  Any previous administration of active study medication.

          -  Known allergy for dairy (bovine) products including cow milk.

          -  Sepsis without renal failure as defined in the Entry Criteria.

          -  History of chronic renal failure or history of persistent creatinine level equal or
             greater than 150umol/L prior to entry for reasons other than the current sepsis
             condition".