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

Genentech

Status and phase: Completed; Phase 1

Conditions: Bacteremia

Treatments: Drug: DSTA4637S; Drug: SOC; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03162250

GV39131

2016-001880-35 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 4 patient groups, including a placebo group

DSTA4637S low dose level + SOC

Experimental group

Description:

DSTA4637S low dose level intravenous (IV) infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics.

Treatment:

Drug: DSTA4637S

Drug: SOC

DSTA4637S intermediate dose level+ SOC

Experimental group

Description:

DSTA4637S intermediate dose level IV infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics.

Treatment:

Drug: DSTA4637S

Drug: SOC

DSTA4637S high dose level+ SOC

Experimental group

Description:

DSTA4637S high dose level IV infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics.

Treatment:

Drug: DSTA4637S

Drug: SOC

Placebo + SOC

Placebo Comparator group

Description:

Placebo matched to DSTA4637S IV infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics.

Treatment:

Drug: Placebo

Drug: SOC