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Trial record 83 of 751 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

A Study of the Safety and Efficacy of 514G3 in Subjects Hospitalized With Bacteremia Due to Staphylococcus Aureus

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ClinicalTrials.gov Identifier: NCT02357966
Recruitment Status : Completed
First Posted : February 6, 2015
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
XBiotech, Inc.

Brief Summary:
This study will evaluate the maximum safe dose of the true human monoclonal antibody, 514G3, in the treatment of patients with Staphylococcus Aureus bacteremia. Preliminary evidence of efficacy will be evaluated as well. Patients will receive 514G3 plus antibiotics or placebo plus antibiotics in approximately a 3 to 1 ratio.

Condition or disease Intervention/treatment Phase
Staphylococcus Aureus Bacteremia Biological: 514G3 Drug: Placebo Drug: Standard IV antibiotic therapy Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : February 2017

Arm Intervention/treatment
Experimental: 514G3
Phase I of the study will include a single dose of 514G3 at three different dose levels. Phase II utilizes a single dose of 514G3 at the highest dose level. Standard antibiotic therapies will be used in both phases.
Biological: 514G3
True Human Monoclonal Antibody

Drug: Standard IV antibiotic therapy
standard antibiotic therapy will be determined by the attending physician and will be guided by the results of cultures with sensitivities.

Placebo Comparator: Placebo
Both Phase I and II will include a single dose of placebo in addition to standard antibiotic therapies.
Drug: Placebo
Buffered saline solution

Drug: Standard IV antibiotic therapy
standard antibiotic therapy will be determined by the attending physician and will be guided by the results of cultures with sensitivities.




Primary Outcome Measures :
  1. Phase I: Determination of the Maximum Tolerated Dose [ Time Frame: 14 Days ]
    The highest dose administered with no more than one dose limiting toxicity

  2. Phase II: Safety and tolerability [ Time Frame: 28 days ]
    The incidence of adverse events, serious adverse events, and laboratory abnormalities will be compared between the 514G3 arm and the placebo arm.


Secondary Outcome Measures :
  1. Determination of the serum half-life of 514G3 [ Time Frame: 28 days ]
    Serum levels of 514G3 will be measured at protocol specified timepoints to determine the half-life, and to ensure clearance of the antibody during the follow up period after dosing.

  2. Duration of Fever [ Time Frame: 28 days ]
  3. Length of hospitalization [ Time Frame: 28 days ]
  4. Time to sterile culture from date of randomization [ Time Frame: 28 Days ]
    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

  5. Incidence of Serious Adverse Events [ Time Frame: 28 days ]
    Differences in the incidence of SAEs between the 514G3 and placebo arms will be compared.

  6. Opsonophagocytosis Assay [ Time Frame: 14 days ]
    Serum samples from patients will be assessed with an in vitro opsonophagocytosis assay which measures the ability of the serum to mediate uptake of staph aureus by white blood cells. Differences in the levels of activity will be compared between treatment and placebo



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357966


Locations
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United States, Georgia
XBiotech Investigative Site
Columbus, Georgia, United States, 31904
United States, North Carolina
XBiotech Investigative Site
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
XBiotech, Inc.
Investigators
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Study Chair: Mark Rupp, M.D. University of Nebraska

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Responsible Party: XBiotech, Inc.
ClinicalTrials.gov Identifier: NCT02357966     History of Changes
Other Study ID Numbers: 2014-PT029
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by XBiotech, Inc.:
Staph
antibody
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Physiological Effects of Drugs
Antitubercular Agents
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Antibodies
Immunologic Factors