Bacteremia
Conditions
Brief 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.
Interventions
DRUGDSTA4637S
DSTA4637S will be administered as an IV infusion at 3 dose levels.
DRUGPlacebo
Placebo matched to DSTA4637S IV infusion will be administered as specified.
DRUGSOC
Anti-staphylococcal SOC antibiotics dosage and duration of therapy will be based on relevant health-authority approved indications and local and national treatment guidelines.
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Body mass index greater than or equal (\>/=) 18 to less than or equal to (\</=) 40 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Adverse Events (AEs) | Baseline up to approximately 156 Days |
Secondary
| Measure | Time frame |
|---|---|
| Measure of Antibody-Conjugated 4-Dimethylamino Piperidino-Hydroxybenzoxazino Rifamycin (dmDNA31) measured by Plasma | Baseline up to approximately 156 Days |
| Measure of DSTA4637S Total Antibody measured by Serum | Baseline up to approximately 156 Days |
| Measure of Unconjugated dmDNA31 measured by Plasma | Baseline up to approximately 156 Days |
| Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to DSTA4637S | Baseline up to approximately 156 Days |
Countries
South Korea, Spain, United States
Outcome results
None listed