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

• Status: Completed
• Trial end date: 2020-01-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular

Criteria

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