Staphylococcus Aureus BacteremiaPhase 1/2NCT02357966
Safety & Efficacy of True Human Antibody, 514G3, in Staphylococcus Aureus Bacteremia Hospitalized Subjects.
A Phase 1/2 study testing 514G3 (2 mg/kg) plus standard IV antibiotic treatment, 514G3 (10 mg/kg) plus standard IV antibiotic treatment and 514G3 (40 mg/kg) plus standard IV antibiotic treatment in people with Staphylococcus Aureus Bacteremia, run by XBiotech, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus Bacteremia
- What is being tested?
- 514G3 (2 mg/kg) plus standard IV antibiotic treatment, 514G3 (10 mg/kg) plus standard IV antibiotic treatment and 514G3 (40 mg/kg) plus standard IV antibiotic treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to Dec 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
XBiotech Investigative Site
Charlotte, North Carolina, 28203
XBiotech Investigative Site
Columbus, Georgia, 31904
About this study
Official title: 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
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.
Read the detailed description
The Phase I/II trial aims to assess the safety and efficacy of True Human monoclonal antibody 514G3 in hospitalized subjects with Staphylococcus aureus bacteremia.
Phase I entails dose escalation, with subjects randomized (3:1) at three dose levels of the study drug (2 mg/kg, 10 mg/kg, and 40 mg/kg) and placebo, utilizing central randomization. Dose-limiting toxicities (DLTs), defined as Grade 3 or greater adverse events related to 514G3 during follow-up, guide escalation. The Maximum Tolerated Dose (MTD) is determined based on DLT occurrence.
Phase II, focusing on preliminary efficacy, randomizes eligible subjects (2:1) to receive 514G3 or placebo with standard IV antibiotic therapy. Safety and efficacy assessments are conducted for both phases, encompassing pooled data from both the study drug and placebo groups.
- Conditions
- Staphylococcus Aureus Bacteremia
- Being tested
- 514G3 (2 mg/kg) plus standard IV antibiotic treatment, 514G3 (10 mg/kg) plus standard IV antibiotic treatment, 514G3 (40 mg/kg) plus standard IV antibiotic treatment, Placebo plus standard IV antibiotic treatment, 514G3 (40 mg/kg) plus standard IV antibiotic treatment: Phase II
- Keywords
- Staphylococcus Aureus, Bacteremia, Hospitalization, Antibody
- Medical subject headings
- Staphylococcal Infections, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
514G3 (2 mg/kg) plus standard IV antibiotic treatmentBiological
Also called True Human Monoclonal Antibody
514G3 (10 mg/kg) plus standard IV antibiotic treatmentBiological
Also called True Human Monoclonal Antibody
514G3 (40 mg/kg) plus standard IV antibiotic treatmentBiological
Also called True Human Monoclonal Antibody
Placebo plus standard IV antibiotic treatmentOther
Also called True Human Monoclonal Antibody
Sterile isotonic formulation buffered at pH 6.2 - 6.5 plus standard IV antibiotic treatment
514G3 (40 mg/kg) plus standard IV antibiotic treatment: Phase IIBiological
Also called True Human Monoclonal Antibody
A single dose of 514G3 plus standard IV antibiotic therapy
Placebo plus standard IV antibiotic treatment: Phase IIOther
Also called True Human Monoclonal Antibody
A single dose of placebo plus standard IV antibiotic therapy
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Experimental | A phase I of the trial is a dose escalation study intended to assess the possible toxicity and to determine the recommended phase 2 dose (RP2D) of the study drug (514G3).
Randomized subjects were administered the study drug at 3 dose levels i.e. 2 mg/kg, 10 mg/kg, and 40 mg/kg or placebo. Receives: Biological: 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; Other: Placebo plus standard IV antibiotic treatment |
| Phase II | Experimental | A phase 2 of the trial is a dose expansion study designed to assess the preliminary efficacy. Eligible subjects are randomized (2:1) and received a single dose of 40 mg/kg study drug (514G3) with standard IV treatment versus placebo with standard IV treatment. Receives: Biological: 514G3 (40 mg/kg) plus standard IV antibiotic treatment: Phase II; Other: Placebo plus standard IV antibiotic treatment: Phase II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Dose-limiting Toxicities
Dose limiting Toxicity are defined as any Grade 3 or greater AE which is probably or definitely related to 514G3 occurring during the FU period after dosing. This measure determines and assesses the maximum tolerated dose (MTD) through participants who experienced DLT at different dose levels.
Measured: Pre-dose at Day 0 through Day 14. After day 14, samples are collected every other day including discharge, up to 30 days maximum
Number of Participants Who Experienced the Adverse Events
A summary of SAEs and other non-serious AEs, regardless of causality
Measured: Adverse events occurring between day 0 and day 30 or hospital discharge whichever is shorter
Secondary outcomes (4)
Time to Clearance of Bacteremia (Time to Sterile Culture From Date of Randomization)
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.
Measured: Pre-dose at Day 0 through Day 14. After day 14, samples are collected every other day including discharge, up to 30 days maximum
Steady State Maximum Concentration of 514G3
Blood samples were collected from participants who received study drug 514G3 for the determination of plasma concentration (Cmax).
Measured: Pre-dose at Day 0 through Day 14. After day 14, samples are collected every other day including discharge, up to 30 days maximum
Length of Hospitalization (Duration of Hospitalization Stay After Randomization)
This outcome measure assesses the impact of the treatment on the time that participants spend in the hospital. The duration of hospitalization is expressed as the average number of days hospitalized for all participants in their respective cohorts.
Measured: Pre-dose at Day 0 through Day 14. After day 14, samples are collected every other day including discharge, up to 30 days maximum
Difference in Opsonophagocytosis Activity Between Arms (Pharmacodynamics)
Serum samples from patients will be assessed with an in-vitro Opsonophagocytosis assay which measures the ability of the serum to mediate uptake of staphylococcus aureus by white blood cells. Differences in the levels of activity will be compared between treatment and placebo. This outcome measure assesses the dose-dependent functional antibody response to 514G3, providing insights into its potential efficacy across different dosage levels compared to placebo. Higher titers in the drug-treated groups indicate better opsonophagocytic activity and thus better efficacy of the drug.
Opsonophagocytosis activity (OPA) score quantifies the functional antibody response to the investigational drug 514G3.
For Phase II, this score is determined using an Opsonophagocytosis assay and is calculated as follows:
Relative Opsonophagocytosis activity = %Phagocytosis 30 minutes after treatment adjusted by baseline / %Phagocytosis of 500 ug/mL spike standard.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Staphylococcus Aureus BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a Phase I/II, double blind placebo controlled trial of the True Human monoclonal antibody 514G3 in subjects hospitalized with Staphylococcus Aureus bacteremia. A phase I of the trial is a dose escalation study intended to assess the possible toxicity and to determine the recommended phase 2 dose of the study drug (514G3). Eligible subjects will be randomized (3:1) to receive single dose of 514G3 (Either 2, 10, 40 mg/kg) plus standard IV antibiotic therapy or single dose of placebo plus standard IV antibiotic therapy. A phase 2 of the trial is designed to assess the preliminary efficacy through randomization of subjects in two arm groups i.e. a single dose of 514G3 administered at the RP2D with standard IV treatment or placebo plus standard IV treatment. Eligible subjects will be randomized (2:1) to receive either a single dose of 514G3 plus standard IV antibiotic therapy versus a single dose of placebo plus standard IV antibiotic treatment.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- XBiotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Rupp, M.D., Study chair, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357966
- Sponsor's protocol ID
- 2014-PT029
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2015
- Last updated
- 9 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data integrity and confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02357966
- Acronym / sponsor ID
- 2014-PT029
- Conditions
- Staphylococcus Aureus Bacteremia
- Keywords
- Staphylococcus Aureus, Bacteremia, Hospitalization, Antibody
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- XBiotech, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Posted 21 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Phase I/II trial aims to assess the safety and efficacy of True Human monoclonal antibody 514G3 in hospitalized subjects with Staphylococcus aureus bacteremia.
Phase I entails dose escalation, with subjects randomized (3:1) at three dose levels of the study drug (2 mg/kg, 10 mg/kg, and 40 mg/kg) and placebo, utilizing central randomization. Dose-limiting toxicities (DLTs), defined as Grade 3 or greater adverse events related to 514G3 during follow-up, guide escalation. The Maximum Tolerated Dose (MTD) is determined based on DLT occurrence.
Phase II, focusing on preliminary efficacy, randomizes eligible subjects (2:1) to receive 514G3 or placebo with standard IV antibiotic therapy. Safety and efficacy assessments are conducted for both phases, encompassing pooled data from both the study drug and placebo groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a Phase I/II, double blind placebo controlled trial of the True Human monoclonal antibody 514G3 in subjects hospitalized with Staphylococcus Aureus bacteremia. A phase I of the trial is a dose escalation study intended to assess the possible toxicity and to determine the recommended phase 2 dose of the study drug (514G3). Eligible subjects will be randomized (3:1) to receive single dose of 514G3 (Either 2, 10, 40 mg/kg) plus standard IV antibiotic therapy or single dose of placebo plus standard IV antibiotic therapy. A phase 2 of the trial is designed to assess the preliminary efficacy through randomization of subjects in two arm groups i.e. a single dose of 514G3 administered at the RP2D with standard IV treatment or placebo plus standard IV treatment. Eligible subjects will be randomized (2:1) to receive either a single dose of 514G3 plus standard IV antibiotic therapy versus a single dose of placebo plus standard IV antibiotic treatment.
| Arm | Type | Receives |
|---|---|---|
| Phase I | Experimental | Biological: 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, Other: Placebo plus standard IV antibiotic treatmentA phase I of the trial is a dose escalation study intended to assess the possible toxicity and to determine the recommended phase 2 dose (RP2D) of the study drug (514G3). Randomized subjects were administered the study drug at 3 dose levels i.e. 2 mg/kg, 10 mg/kg, and 40 mg/kg or placebo. |
| Phase II | Experimental | Biological: 514G3 (40 mg/kg) plus standard IV antibiotic treatment: Phase II, Other: Placebo plus standard IV antibiotic treatment: Phase IIA phase 2 of the trial is a dose expansion study designed to assess the preliminary efficacy. Eligible subjects are randomized (2:1) and received a single dose of 40 mg/kg study drug (514G3) with standard IV treatment versus placebo with standard IV treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 514G3 (2 mg/kg) plus standard IV antibiotic treatmentAlso: True Human Monoclonal Antibody | Biological | Phase I |
| 514G3 (10 mg/kg) plus standard IV antibiotic treatmentAlso: True Human Monoclonal Antibody | Biological | Phase I |
| 514G3 (40 mg/kg) plus standard IV antibiotic treatmentAlso: True Human Monoclonal Antibody | Biological | Phase I |
| Placebo plus standard IV antibiotic treatmentAlso: True Human Monoclonal AntibodySterile isotonic formulation buffered at pH 6.2 - 6.5 plus standard IV antibiotic treatment | Other | Phase I |
| 514G3 (40 mg/kg) plus standard IV antibiotic treatment: Phase IIAlso: True Human Monoclonal AntibodyA single dose of 514G3 plus standard IV antibiotic therapy | Biological | Phase II |
| Placebo plus standard IV antibiotic treatment: Phase IIAlso: True Human Monoclonal AntibodyA single dose of placebo plus standard IV antibiotic therapy | Other | Phase II |
Primary outcome
Number of Participants Who Experienced Dose-limiting Toxicities
Time frame: Pre-dose at Day 0 through Day 14. After day 14, samples are collected every other day including discharge, up to 30 days maximum
Dose limiting Toxicity are defined as any Grade 3 or greater AE which is probably or definitely related to 514G3 occurring during the FU period after dosing. This measure determines and assesses the maximum tolerated dose (MTD) through participants who experienced DLT at different dose levels.
Number of Participants Who Experienced the Adverse Events
Time frame: Adverse events occurring between day 0 and day 30 or hospital discharge whichever is shorter
A summary of SAEs and other non-serious AEs, regardless of causality
4 secondary outcomes
Time to Clearance of Bacteremia (Time to Sterile Culture From Date of Randomization)
Time frame: Pre-dose at Day 0 through Day 14. After day 14, samples are collected every other day including discharge, up to 30 days maximum
Steady State Maximum Concentration of 514G3
Time frame: Pre-dose at Day 0 through Day 14. After day 14, samples are collected every other day including discharge, up to 30 days maximum
Length of Hospitalization (Duration of Hospitalization Stay After Randomization)
Time frame: Pre-dose at Day 0 through Day 14. After day 14, samples are collected every other day including discharge, up to 30 days maximum
Difference in Opsonophagocytosis Activity Between Arms (Pharmacodynamics)
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data integrity and confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Rupp, M.D. study chair
University of Nebraska
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 514G3 (2 mg/kg) plus standard IV antibiotic treatment, 514G3 (10 mg/kg) plus standard IV antibiotic treatment and 514G3 (40 mg/kg) plus standard IV antibiotic treatment in people with Staphylococcus Aureus Bacteremia, run by XBiotech, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced Dose-limiting Toxicities (time frame: Pre-dose at Day 0 through Day 14. After day 14, samples are collected every other day including discharge, up to 30 days maximum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.