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

Completed · Phase 1 · Has a placebo group

Conditions studied: Bacteremia

In brief

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.

Key facts

Study ID

NCT03162250

Run by

Genentech, Inc.

People needed

27

Starts

2017-07-13

Expected to finish

2020-01-15

Last updated by the study team

2020-01-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Los Angeles Biomedical Research Institute at Harbor-UCLA — Torrance, California, United States
• Henry Ford Health System — Detroit, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Chungnam National University Hospital — Daejeon, South Korea
• Gyeongsang National University Hospital — Gyeongsangnam-do, South Korea
• Asan Medical Center - Oncology — Seoul, South Korea
• Korea University Guro Hospital — Seoul, South Korea
• Hospital Universitario de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain
• Hospital Mutua de Terrassa — Terrassa, Barcelona, Spain
• Hospital Universitario Marques de Valdecilla — Santander, Cantabria, Spain
• Hospital del Mar — Barcelona, Spain
• Hospital Clinic de Barcelona — Barcelona, Spain
• Hospital Universitario Ramon y Cajal — Madrid, Spain
• Hospital Universitario Virgen Macarena — Seville, Spain
• Hospital Universitario Virgen del Rocio — Seville, Spain

Full record on ClinicalTrials.gov

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