Clinical Trials List
2015-10-01 - 2017-07-31
Phase I/II
Terminated4
ICD-10 B95.6
Staphylococcus aureus as the cause of diseases classified elsewhere
A Phase I-II Study of the Safety and Efficacy of a True Human Antibody, 514G3, in Subjects Hospitalized With Bacteremia Due to Staphylococcus Aureus
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Trial Applicant
Clinipace Taiwan Co., Ltd
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 蔡欣諺 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 李原地 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
Audit
None
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Po-Liang Lu Division of Infectious Disease
- 鄭宇辰 Division of Infectious Disease
- Shang-Yi Lin Division of Infectious Disease
- 林蔚如 Division of Infectious Disease
- Chung-Hao Huang Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Phase I: Determination of the Maximum Tolerated Dose [ Time Frame: 14 Days ]
The highest dose administered with no more than one dose limiting toxicity
Phase II: Safety and tolerability [ Time Frame: 28 days ]
The incidence of adverse events, serious adverse events, and laboratory abnormalities will be compared between the 514G3 arm and the placebo arm.
Secondary Outcome Measures :
Determination of the serum half-life of 514G3 [ Time Frame: 28 days ]
Serum levels of 514G3 will be measured at protocol specified timepoints to determine the half-life, and to ensure clearance of the antibody during the follow up period after dosing.
Duration of Fever [ Time Frame: 28 days ]
Length of hospitalization [ Time Frame: 28 days ]
Time to sterile culture from date of randomization [ Time Frame: 28 Days ]
The time to sterile culture is the interval in days from the first dose of study drug until 2 consecutive days of negative blood cultures has occurred. The difference in this interval will be compared between patients randomized to placebo and those who received the highest dose of 514G3
Incidence of Serious Adverse Events [ Time Frame: 28 days ]
Differences in the incidence of SAEs between the 514G3 and placebo arms will be compared.
Opsonophagocytosis Assay [ Time Frame: 14 days ]
Serum samples from patients will be assessed with an in vitro opsonophagocytosis assay which measures the ability of the serum to mediate uptake of staph aureus by white blood cells. Differences in the levels of activity will be compared between treatment and placebo
Inclution Criteria
One or more blood cultures positive for staphylococcus aureus within 2 days of initiating treatment with 514G3.
Temperature ≥ 38.0°C
Age ≥18, male or female subjects.
Adequate renal function, defined by serum creatinine ≤ 2 times the upper limit of normal (ULN).
Adequate hepatic function
Adequate bone marrow function
For women of childbearing potential (WOCBP), a negative serum pregnancy test result at Screening.
Signed and dated institutional review board (IRB)/ Ethics Committee (EC)-approved informed consent before any protocol-specific screening procedures are performed.
Expected survival of at least 2 months.
Exclusion Criteria
Polymicrobial bacteremia.
Known or suspected osteomyelitis or meningitis.
Patients that are being mechanically ventilated as a result of a pulmonary infection at the time of screening. Mechanical ventilation for other reasons, such as trauma, is acceptable.
Presence of any removable infection source (e.g., intravascular line, abscess, or prosthesis) that will not be removed or debrided within 3 days after randomization.
Definite or possible left-sided endocarditis, by Modified Duke Criteria, based on screening echocardiogram. Subjects with suspected right-sided endocarditis are permitted.
Need for emergent valve surgery at the time of screening, and/or the presence of decompensated heart failure or cardiogenic shock.
Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
Infection with human immunodeficiency virus (HIV) and a CD4 count <200 cells/mm3.
Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition to 514G3 or any component of its formulations.
Women who are pregnant or breastfeeding.
The Estimated Number of Participants
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Taiwan
8 participants
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Global
36 participants
