Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Participants With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care (SOC) Antibiotics



Status:Recruiting
Conditions:Infectious Disease, Hematology
Therapuetic Areas:Hematology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 80
Updated:4/5/2019
Start Date:July 13, 2017
End Date:November 22, 2019
Contact:Reference Study ID Number: GV39131 www.roche.com/abo
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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A Phase IB, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Patients With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care Antibiotics

This is a Phase Ib, randomized double-blind, placebo-controlled multiple-ascending dose study
to investigate the safety, tolerability, and pharmacokinetics of multiple doses of DSTA4637S
when given in addition to anti-staphylococcal SOC antibiotics to participants with
methicillin-resistant staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus
aureus (MSSA) bacteremia requiring at least 4 weeks of anti-staphylococcal SOC antibiotics.


Inclusion Criteria:

- Body mass index greater than or equal (>/=) 18 to less than or equal to ( kg/m^2

- At randomization, participants must have >/=1 blood culture or molecular diagnostic
that is positive for Staphylococcal aureus (S. aureus) collected in the previous 120
hours

- In the investigator's judgment, an expected treatment duration for S. aureus
intravenous infection with anti-staphylococcal SOC antibiotics >/= 4 weeks

Exclusion Criteria:

- The presence of an intravascular catheter that is not planned to be removed within 96
hours of study randomization

- S. aureus bacteremia associated with an intracardiac device and/or intravascular
prosthetic material (including hemodialysis access graft)

- In the investigator's judgement, S. aureus bacteremia involving infection of a
prosthetic joint or vertebral hardware

- In participants with cirrhosis, a Child-Pugh Score of Class B or C

- Known rifampicin-resistant S. aureus

- Anticipated receipt of a rifamycin class (excluding rifaxamin) antibiotic from Day 1
to study completion/discontinuation

- In the investigator's judgment, the need for emergent valve surgery at the time of
randomization or a high likelihood of cardiac surgery within 3 days after
randomization

- Polymicrobial bacteremia

- Participants with significant immune suppression

- Participants with evidence of liver disease

- History or presence of an abnormal electrocardiogram (ECG)

- Exposure to any biological therapy or investigational biological agent within 90 days
prior to the screening evaluation or have received any other investigational treatment
30 days prior to the screening evaluation
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800 Washington St
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(617) 636-5000
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Detroit, Michigan 48202
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2301 Erwin Rd
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919-684-8111
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Royal Oak, Michigan 48073
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