MedTrace Logo

Phase IIa Clinical Study of N-Rephasin® SAL200

NCT03089697 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-10-06

Study results available
· View outcomes & findings →

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.

Conditions

  • Staphylococcus Aureus Bacteremia
  • Anti-Bacterial Agents

Interventions

BIOLOGICAL

N-Rephasin® SAL200

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Intron Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Hong-Bin Kim, M.D, PhD · Seoul National University Bundang Hospital

  • Wan Beom Park, M.D, PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-07
Primary Completion
2019-11-07
Completion
2019-11-07

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03089697 on ClinicalTrials.gov