Skip to main content
OpenTrials
Completed

NCT Number: NCT03162250

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chungnam National University Hospital, Daejeon, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DSTA4637S

Drug

DSTA4637S will be administered as an IV infusion at 3 dose levels.

Placebo

Drug

Placebo matched to DSTA4637S IV infusion will be administered as specified.

SoC

Drug

Anti-staphylococcal SOC antibiotics dosage and duration of therapy will be based on relevant health-authority approved indications and local and national treatment guidelines.

Primary outcomes

  1. Percentage of Participants With Adverse Events (AEs)

    Time frame: Baseline up to approximately 156 Days

Secondary outcomes

  1. Measure of Antibody-Conjugated 4-Dimethylamino Piperidino-Hydroxybenzoxazino Rifamycin (dmDNA31) measured by Plasma

    Time frame: Baseline up to approximately 156 Days

  2. Measure of DSTA4637S Total Antibody measured by Serum

    Time frame: Baseline up to approximately 156 Days

  3. Measure of Unconjugated dmDNA31 measured by Plasma

    Time frame: Baseline up to approximately 156 Days

  4. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to DSTA4637S

    Time frame: Baseline up to approximately 156 Days

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase IB, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Patients With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care Antibiotics

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 22, 2017
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.