Phase IIa Clinical Study of N-Rephasin® SAL200

NCT03089697 | Terminated Phase 2 Results

• 1 other identifier: ITB-101
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

N-Rephasin SAL200; Methicillin-Sensitive Staphylococcus aureus; Methicillin Resistant Staphylococcus Aureus

Outcome Measures

Primary Outcomes (1)

• Safety Endpoints - Summary of Treatment-emergent Adverse Events (Safety Set)

  The safety analysis was conducted based on the data of all AEs, physical examinations, clinical laboratory tests, and vital signs (blood pressure, pulse rate, body temperature, and respiratory rate) collected from the subjects. All subjects who enrolled in this study (13 subjects in the placebo group and 12 subjects in the N RephasinⓇ SAL200 group) were defined as the Safety Set and included in the analysis.

  up to 4 Week ± 5 Days

Secondary Outcomes (3)

• Efficacy Endpoints 1

  by day 14

• Efficacy Endpoint 2

  by day 14

• Efficacy Endpoint 3

  by day 14

Study Arms (2)

N-Rephasin® SAL200

EXPERIMENTAL

To assign the study group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with N-Rephasin® SAL200 (3mg/kg); N-Rephasin® SAL 200 is given by intravenous only once at Day 1.

Biological: N-Rephasin® SAL200

Placebo

PLACEBO COMPARATOR

To assign the control group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with Formulation buffer (placebo); Placebo (INT200) is given by intravenous only once at Day 1 (same way with Experimental group)

Other: Placebo

Interventions

N-Rephasin® SAL200 BIOLOGICAL

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

N-Rephasin® SAL200

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Males or females aged 19 years or older
• Those who understand the explanatory notes for subjects, and sign the informed consent.

You may not qualify if:

• 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)
• 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
• 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
• 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
• 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
• Pregnant or lactating women and women of child-bearing potential (who do not agree to take appropriate contraceptive measures during the trial period)
• Those who participated in other clinical trial within 30 days prior to enrollment
• Patients with any conditions that may interfere with study participation or accurate evaluation on investigator's judgment
• Those who may die within 72 hours due to other serious complications (e.g., cerebral infarction, etc.), as per the investigator's judgment

Sponsors & Collaborators

• Intron Biotechnology, Inc.: lead

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (4)

• Kundsin RB. Documentation of airborne infection during surgery. Ann N Y Acad Sci. 1980;353:255-61. doi: 10.1111/j.1749-6632.1980.tb18928.x. No abstract available.

  PMID: 6939390 RESULT

• Etienne J, Fleurette J, Ninet JF, Favet P, Gruer LD. Staphylococcal endocarditis after dental extraction. Lancet. 1986 Aug 30;2(8505):511-2. doi: 10.1016/s0140-6736(86)90377-6. No abstract available.

  PMID: 2875256 RESULT

• Lamy B, Dargere S, Arendrup MC, Parienti JJ, Tattevin P. How to Optimize the Use of Blood Cultures for the Diagnosis of Bloodstream Infections? A State-of-the Art. Front Microbiol. 2016 May 12;7:697. doi: 10.3389/fmicb.2016.00697. eCollection 2016.

  PMID: 27242721 RESULT

• van Hal SJ, Jensen SO, Vaska VL, Espedido BA, Paterson DL, Gosbell IB. Predictors of mortality in Staphylococcus aureus Bacteremia. Clin Microbiol Rev. 2012 Apr;25(2):362-86. doi: 10.1128/CMR.05022-11.

  PMID: 22491776 RESULT

Related Links

• Frency J, Brun Y, Bes M, Meugnier H, Grimont F, Grimon PAD, Newi C, Fleurette J. Staphylococcus lugdunensis sp. and Staphylococcus schleiferi sp. novel two species from human clinical specimens. Int Syst Bacteriol. 1998;38:168-172
• Seung-Ho Han et al., Monitoring of Methicillin-Resistant Staphylococcus aureus in Nasal Swabs Obtained fron Dental Clinic Healthcare Providers and Medical Environments Nurses. Int J Oral Biology. 2010;35:7-12
• Hyuk Min Lee, Dong Eun Yong, Kyungwon Lee., Antimicrobial Resistance of Clinically Important Bacteria Isolated from 12 Hospitals in Korea in 2004 . Korean Journal of Clinical Microbiology 2005;8(1):66-73
• Woo J-H, Song J-H, Cheong H-S, Lee E-K, Chae S-M, Kim N-J. Analysis of Economic Outcomes of Methicillin-Resistant Staphylococcus Aureus(MRSA) Bacteremia Using Retrospective Case-Control Study. Korean J Clin Pharm 2007;17(2):59-64.
• Lee, H, Yong, D, Lee, K, Hong, S, Kim, E, Jung, S, Park, Y, Choi, T, Eo, Y, Shin, J et al. Antimicrobial Resistance of Clinically Important Bacteria Isolated from 12 Hospitals in Korea in 2004. Korean J Clinical Microbiology 2005;8(1):66-73

Limitations and Caveats

Enrollment into this study was terminated by the Sponsor prior to completion for strategic reasons (to initiate clinical development abroad).

Results Point of Contact

• Title: Jun SooYoun, Ph.D. / Executive Director/ Principal researcher
• Organization: Institute of iNtRON Biotechnology

jsy@intron.co.kr

+82-31-739-5332

Study Officials

• Hong-Bin Kim, M.D, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• Wan Beom Park, M.D, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: March 24, 2017
• Study Start: March 7, 2017
• Primary Completion: November 7, 2019
• Study Completion: November 7, 2019
• Last Updated: October 6, 2021
• Results First Posted: August 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)