Phase IIa Clinical Study of N-Rephasin® SAL200 (NCT03089697) | Clinical Trial Compass
TerminatedPhase 2
Phase IIa Clinical Study of N-Rephasin® SAL200
Stopped: Enrollment into this study was terminated by the Sponsor prior to completion for strategic reasons.
South Korea25 participantsStarted 2017-03-07
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
âś“. 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.
âś“. Males or females aged 19 years or older
âś“. Those who understand the explanatory notes for subjects, and sign the informed consent.
Exclusion criteria
âś•. 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)
âś•. 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
âś•. 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
âś•. Those who have symptoms of septic shock at the time of acquisition of the consent form
What they're measuring
1
Safety Endpoints - Summary of Treatment-emergent Adverse Events (Safety Set)
âś•. Those who were infected with mixed bacterial species
✕. Those who are hypersensitive to N-Rephasin® SAL200, who have a clinically significant hypersensitivity to it, or a past history there of
âś•. Pregnant or lactating women and women of child-bearing potential (who do not agree to take appropriate contraceptive measures during the trial period)
âś•. Those who participated in other clinical trial within 30 days prior to enrollment