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Experimental antibody targets deadly staph infections

NCT ID NCT02357966

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a lab-made antibody called 514G3 in 52 hospitalized adults with Staphylococcus aureus bloodstream infections. Participants received either a single dose of the antibody plus standard antibiotics or a placebo plus antibiotics. The main goals were to check safety and find the best dose. Results are not yet available, but the trial aims to see if adding this antibody can help clear the infection more effectively.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
514G3 (a human monoclonal antibody) given as a single intravenous dose alongside standard antibiotics
What this could lead to
If successful, this antibody could become an add-on treatment to help clear Staph bloodstream infections faster and more safely.
What could go wrong
This is an early-phase trial with only 52 participants, so results may not apply broadly. The antibody is experimental and may not improve outcomes over antibiotics alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

52 people

The number who actually took part.

Started

May 2015

Finished

Dec 2016

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. One or more blood cultures positive for staphylococcus aureus within 2 days of initiating treatment with 514G3. 2. Temperature ≥ 38.0°C 3. Age ≥18, male or female subjects. 4. Adequate renal function, defined by serum creatinine ≤ 2 times the upper limit of normal (ULN). 5. Adequate hepatic function 6. Adequate bone marrow function 7. For women of childbearing potential (WOCBP), a negative serum pregnancy test result at Screening. 8. Signed and dated institutional review board (IRB)/ Ethics Committee (EC)-approved informed consent before any protocol-specific screening procedures are performed. 9. Expected survival of at least 2 months. Exclusion Criteria: 1. Polymicrobial bacteremia. 2. Known or suspected osteomyelitis or meningitis. 3. 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. 4. 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. 5. Definite or possible left-sided endocarditis, by Modified Duke Criteria, based on screening echocardiogram. Subjects with suspected right-sided endocarditis are permitted. 6. Need for emergent valve surgery at the time of screening, and/or the presence of decompensated heart failure or cardiogenic shock. 7. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent. 8. Infection with human immunodeficiency virus (HIV) and a CD4 count \<200 cells/mm3. 9. Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition to 514G3 or any component of its formulations. 10. Women who are pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • XBiotech Investigative Site

    Columbus, Georgia, 31904, United States

  • XBiotech Investigative Site

    Charlotte, North Carolina, 28203, United States

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