ot available

Phase 1

• Conditions: Staphylococcus aereus Bacteremia; MedDRA version: 19.1Level: LLTClassification code 10058887Term: Staphylococcus aureus bacteremiaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-003510-25-DE
• Lead Sponsor: XBiotech USA, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-01
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

No waivers/exemptions will be granted for protocol inclusion/exclusion criteria.

Subjects are included in the study if they meet all of the following criteria:
1.One or more blood cultures positive for staphylococcus aureus within 2 days of randomization. Note that the 2-day clock begins when the culture is determined to be positive for staphylococcus aureus, and not when the culture was drawn.
2.Age =18, male or female subjects.
3.Adequate renal function, defined by serum creatinine = 2 times the upper limit of normal (ULN). However, subjects with chronic renal insufficiency that are receiving dialysis are eligible even with a serum creatinine >2 times the upper limit of normal.
4.Adequate hepatic function defined as:
?Total bilirubin = 3 times the ULN.
?Alanine aminotransferase (ALT) = 10 times the ULN.
5.Adequate bone marrow function as defined as:
?Absolute neutrophil count (neutrophil and bands) of ? 1,500/mm3 (? 1.5 x 109/L)
?Platelet count ? 100,000/mm3
6.For women of childbearing potential (WOCBP), a negative serum pregnancy test result at Screening.
7.Signed and dated institutional review board (IRB)/ Ethics Committee (EC)-approved informed consent before any protocol-specific screening procedures are performed. If the subject is unable to sign, the LAR may sign as their representative.
8.Expected survival unrelated to the staphylococcal bacteremia of at least 2 months.
9.If the patient has a central venous catheter in place at the time of qualifying blood culture, and the bacteremia is thought to be secondary to the catheter, the subject and his/her primary health care provider must agree to having the catheter removed within 5 days of randomization

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52

Exclusion Criteria

Subjects with ANY of the following will be excluded from the study:
1. Polymicrobial bacteremia.
2. Known or suspected complicated bacteremia:
a. Meningitis
b. Brain abscess
c. Epidural abscess
d. Intracranial hemorrhage due to mycotic aneurysm
e. Definite Left Sided Endocarditis as defined by modified Duke criteria (Right-sided endocarditis is allowed):
f. Visceral abscess (Liver,Spleen, Kidney)
g. Staphylococcal Pneumonia (any one criteria below)
i. Pulmonary infiltrate consistent with pneumonia
ii. S aureus recovered from pleural fluid or bronchoalveolar lavage
iii. Clinical evidence of pneumonia (increased FiO2, elevated respiratory rate, cough, purulent sputum)
h. Pyomyositis
i. Septic arthritis
j. Septic thrombophlebitis
3. Need for emergent valve surgery at the time of screening, and/or the presence of decompensated heart failure or cardiogenic shock.
4. History of HIV Infection with a nadir CD4+ count of <200 cells/mm3 upon the most recent measurement
5. Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition to 514G3 or any component of its formulations.
6. Women who are pregnant or breastfeeding.
7. Non-removable intravascular foreign material in-situ when the qualifying blood culture was performed (eg cardiac pacemaker, defibrillator, prosthetic heart valve). Extravascular prostheses (prosthetic joints, surgical mesh, orthopedic pins/plates) are allowed as long as there is no evidence of infection at the site at the time of enrollment.
8. Presence of septic shock during or prior to screening. Septic shock is defined as sepsis-induced hypotension persisting despite adequate fluid resuscitation
9. Investigational agent in past 30 days

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Phase I: Determination of Maximum tolerated dose<br>Phase II: Safety and Tolerability;Secondary Objective: Efficacy of 514G3 in subjects hospitalized with bacteremia, Pharmacokinetics of 514G3;Primary end point(s): Primary Endpoint of Phase I:<br>• MTD will be determined as the dose level at which no subjects experience a single probably or definitely related Grade 4 AE, and no more than one subject experiences a probably or definitely related Grade 3 AE<br>Primary Endpoint of Phase II:<br>• Safety and tolerability of 514G will be assessed by AE’s, serious adverse events including abnormalities of lab parameters <br>;Timepoint(s) of evaluation of this end point: MTD = Day 14 after treatment<br>For safety assessments: Subjects will be followed for 30 days of hospitalization