Phase 2
N=52
Safety & Efficacy of True Human Antibody, 514G3, in Staphylococcus Aureus Bacteremia Hospitalized Subjects.
Staphylococcus Aureus Bacteremia
Bottom Line
View on ClinicalTrials.gov: NCT02357966 ↗Enrolled (actual)
52
Serious AEs
30.8%
Results posted
Nov 2024
Primary outcome: Primary: Number of Participants Who Experienced Dose-limiting Toxicities — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 514G3 (2 mg/kg) plus standard IV antibiotic treatment (Biological); 514G3 (10 mg/kg) plus standard IV antibiotic treatment (Biological); 514G3 (40 mg/kg) plus standard IV antibiotic treatment (Biological); Placebo plus standard IV antibiotic treatment (Other); 514G3 (40 mg/kg) plus standard IV antibiotic treatment: Phase II (Biological); Placebo plus standard IV antibiotic treatment: Phase II (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- XBiotech, Inc.
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Dose-limiting Toxicities |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants Who Experienced the Adverse Events |
1; 1; 1; 2; 5; 5 | — |
| SECONDARY Time to Clearance of Bacteremia (Time to Sterile Culture From Date of Randomization) |
1.67; 3.67; 2.0; 3.5; 2.54; 2.33 | — |
| SECONDARY Steady State Maximum Concentration of 514G3 |
37.5; 198.0; 684.7; 740.0 | — |
| SECONDARY Length of Hospitalization (Duration of Hospitalization Stay After Randomization) |
23.67; 11.33; 11.67; 20; 13.71; 17 | — |
| SECONDARY Difference in Opsonophagocytosis Activity Between Arms (Pharmacodynamics) |
129.7; 1.1 | — |
Summary
This study is a Phase I/II, double-blind, placebo-controlled trial investigating the True Human monoclonal antibody 514G3 in subjects hospitalized with Staphylococcus aureus bacteremia. Phase I involves dose escalation to evaluate potential toxicity and establish the recommended phase 2 dosage of 514G3. In Phase II (dose expansion), eligible subjects will be randomized at a ratio of 2:1 to receive either a single dose of 514G3 with standard IV antibiotic therapy or a single dose of placebo with standard IV antibiotic therapy, aiming to assess safety and tolerability. The trial aims to determine the safety, efficacy, and optimal dosage regimen of 514G3 in these hospitalized subjects.
Eligibility Criteria
Inclusion 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.
Data sourced from ClinicalTrials.gov (NCT02357966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.