Study to Investigate the Safety, Tolerability, and Pharma... | NCT03162250 | Trialant

Study to Investigate the Safety, Tolerability, and Pharma... | NCT03162250 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DSTA4637S low dose level + SOC	Experimental	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.	Drug: DSTA4637S Drug: SOC
DSTA4637S intermediate dose level+ SOC	Experimental	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.	Drug: DSTA4637S Drug: SOC
DSTA4637S high dose level+ SOC	Experimental	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.	Drug: DSTA4637S Drug: SOC
Placebo + SOC	Placebo Comparator	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.	Drug: Placebo Drug: SOC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DSTA4637S	Drug	DSTA4637S will be administered as an IV infusion at 3 dose levels.	DSTA4637S high dose level+ SOC DSTA4637S intermediate dose level+ SOC

Outcomes Module

Secondary Outcomes

Measure	Description	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

Contacts/Locations Module

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D018805	Sepsis
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms