Phase IIa Clinical Study of N-Rephasin® SAL200
Condition: Staphylococcus Aureus Bacteremia; Anti-Bacterial Agents
MeSH terms: Staphylococcal Infections; Bacteremia
Intervention: N-Rephasin® SAL200; Placebo
Intervention description: A single dose of SAL200 (SAL-1, 3mg/kg) intravenous administration of the study drug, in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA; A single dose of the formulation buffer (placebo), excluding the main ingredient of the study drug in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: N-Rephasin SAL200; Methicillin-Sensitive Staphylococcus aureus; Methicillin Resistant Staphylococcus Aureus

Summary:

      This study is performed to evaluate safety and to explore the efficacy of a single
      intravenous dose of N-Rephasin® SAL200 (3 mg/kg) in addition to the conventional standard
      treatment, for persistent Staphylococcus aureus bacteremia in patients, for more than 48
      hours even after antibiotic treatment to which Staphylococcus aureus is susceptible.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with MSSA/MRSA bacteremia who are confirmed to have more than a pair of Gram
             positive bacteria in a blood culture conducted at 48~96 hours after the start of
             antibiotic treatment to which S. aureus is susceptible.

          2. Males or females aged 19 years or older

          3. Those who understand the explanatory notes for subjects, and sign the informed
             consent.

        Exclusion Criteria:

          1. Those who do not receive appropriate antibiotics within 48 hours after the occurrence
             of bacteremia (the time point of reporting it to the department of laboratory
             medicine)

          2. The Gram positive strain, identified in a blood culture conducted at 48~96 hours after
             the start of antibiotic treatment to which S. aureus is susceptible, is not the same
             strain of S. aureus which was cultured when the definite diagnosis of S. aureus
             bacteremia was made

          3. Those who pass 48 hours after confirmation of persistent S. aureus bacteremia through
             a blood culture conducted at 48~96 hours after the start of antibiotic treatment to
             which S. aureus is susceptible

          4. Those who have symptoms of septic shock at the time of acquisition of the consent form

               -  Systolic blood pressure lower than 90 mmHg, or blood pressure lower than usual by
                  more than 40 mmHg, in spite of the application of appropriate fluid therapy

               -  Requirement of hypertensor to maintain the systolic blood pressure at 90 mmHg or
                  higher

          5. Those who were infected with mixed bacterial species

          6. Those who are hypersensitive to N-Rephasin® SAL200, who have a clinically significant
             hypersensitivity to it, or a past history there of

          7. Pregnant or lactating women and women of child-bearing potential (who do not agree to
             take appropriate contraceptive measures during the trial period)

          8. Those who participated in other clinical trial within 30 days prior to enrollment

          9. Patients with any conditions that may interfere with study participation or accurate
             evaluation on investigator's judgment

         10. Those who may die within 72 hours due to other serious complications (e.g., cerebral
             infarction, etc.), as per the investigator's judgment