Safety & Efficacy of True Human Antibody, 514G3, in Staphylococcus Aureus Bacteremia Hospitalized… (NCT02357966) | Clinical Trial Compass
CompletedPhase 1/2
Safety & Efficacy of True Human Antibody, 514G3, in Staphylococcus Aureus Bacteremia Hospitalized Subjects.
United States52 participantsStarted 2015-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
Exclusion criteria
✕. Polymicrobial bacteremia.
✕. Known or suspected osteomyelitis or meningitis.
What they're measuring
1
Number of Participants Who Experienced Dose-limiting Toxicities
Timeframe: Pre-dose at Day 0 through Day 14. After day 14, samples are collected every other day including discharge, up to 30 days maximum
2
Number of Participants Who Experienced the Adverse Events
Timeframe: Adverse events occurring between day 0 and day 30 or hospital discharge whichever is shorter
. 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.