Phase 2 Study of CAL02 plus Standard of Care in Severe Community-Acquired Bacterial Pneumonia (SCABP)

INTERVENTION: Product Name: Natriumchloride 0,9%, oplossing voor infusie,Product Code: PRD2128240,Pharmaceutical Form: SOLUTION FOR INFUSION,Other descriptive name: ,Strength: Sodium Chloride 9g,Pharmaceutical form of the placebo: SOLUTION FOR INFUSION,Route of administration of the placebo: INTRAVENOUS INFUSION,Product Name: CAL02,Product Code: PRD9987424,Pharmaceutical Form: SOLUTION FOR INFUSION,Other descriptive name: ,Strength: Sphingomyelin (Egg) 30mg, Cholesterol 10mg,Current Sponsor code: CAL02 CONDITION: MedDRA version: 20.1Level: LLTClassification code: 10010120Term: Community acquired pneumoniaSystem Organ Class: 10021881 SEVERE COMMUNITY‐ACQUIRED BACTERIAL PNEUMONIA (SCABP) ; MedDRA version: 20.1Level: LLTClassification code: 10010120Term: Community acquired pneumoniaSystem Organ Class: 10021881 Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: Main Objective:‐ To evaluate the effect of CAL02 administration on clinical recovery compared to placebo; ‐ To evaluate the safety and tolerability of CAL02 versus placebo Primary end point(s):Time (days) to clinical recovery, the day all severity criteria which met the SCABP definition per protocol at randomization, and any new severity criteria which occurred after randomization, are resolved, and no repeat or additional severity criteria are met within 24 hours after recovery,Incidence and severity of TEAEs including infusion‐related reactions,Incidence of IMP IV infusion interruptions and discontinuations Secondary Objective:To evaluate the effect of CAL02 administration on the duration of critical care management compared to placebo,To evaluate the effect of CAL02 administration on the duration of overall hospital stay compared to placebo,To evaluate the effect of CAL02 administration on early clinical recovery (by Day 5) compared to placebo,To evaluate the effects of CAL02 administration on SOFA scores compared to placebo SECONDARY OUTCOME: Secondary end point(s):Proportion of subjects who achieve clinical recovery by Day 5 Secondary end point(s):Relative change from baseline in whole SOFA score at Day 7 Secondary end point(s):Time to critical care management discharge (days) Secondary end point(s):Time to hospital discharge (days) INCLUSION CRITERIA: Males or females =18 years old,Body weight 40 to 140 kg (88 to 308 lb), inclusive,Clinical diagnosis of CABP (diagnosed =48 hours after hospital admission),Presence of at least one of the following severity criteria, based on protocol defined SCABP: a. Respiratory failure requiring invasive mechanical ventilation support b. Respiratory failure requiring non‐invasive positive pressure ventilation support (eg, continuous positive airway pressure [C‐PAP], bi‐level positive airway pressure [Bi‐PAP]) and partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) =250 mm Hg, excluding home setting non‐invasive positive pressure ventilation support c. Respiratory failure requiring high‐flow oxygen defined as >40 L/min and PaO2/FiO2 ratio =250 mm Hg d. Septic shock requiring treatment with vasopressors at therapeutic doses (defined as >0.07 µg/kg/min norepinephrine equivalent [Appendi X2]) for at least 2 hours to maintain or attempt to maintain mean arteria