Experimental antibody targets deadly staph infections
NCT ID NCT02357966
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
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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 Hide 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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Other studies related to the condition(s) this trial covers.
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