Back to resultsStudy to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Participants With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care (SOC) Antibiotics
Primary Purpose
Bacteremia
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
DSTA4637S
Placebo
SOC
Sponsored by
About this trial
This is an interventional treatment trial for Bacteremia
Eligibility Criteria
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
Sites / Locations
- Los Angeles Biomedical Research Institute at Harbor-UCLA
- Henry Ford Health System
- William Beaumont Hospital
- Duke University Medical Center
- Chungnam National University Hospital
- Gyeongsang National University Hospital
- Asan Medical Center - Oncology
- Korea University Guro Hospital
- Hospital Universitario de Bellvitge
- Hospital Mutua de Terrassa
- Hospital Universitario Marques de Valdecilla
- Hospital del Mar
- Hospital Clinic de Barcelona
- Hospital Universitario Ramon y Cajal
- Hospital Universitario Virgen Macarena
- Hospital Universitario Virgen del Rocio
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
DSTA4637S low dose level + SOC
DSTA4637S intermediate dose level+ SOC
DSTA4637S high dose level+ SOC
Placebo + SOC
Arm 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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Percentage of Participants With Adverse Events (AEs)
Secondary Outcome Measures
Measure of Antibody-Conjugated 4-Dimethylamino Piperidino-Hydroxybenzoxazino Rifamycin (dmDNA31) measured by Plasma
Measure of DSTA4637S Total Antibody measured by Serum
Measure of Unconjugated dmDNA31 measured by Plasma
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to DSTA4637S
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03162250
Brief Title
Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Participants With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care (SOC) Antibiotics
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 13, 2017 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
January 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteremia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DSTA4637S low dose level + SOC
Arm Type
Experimental
Arm 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.
Arm Title
DSTA4637S intermediate dose level+ SOC
Arm Type
Experimental
Arm 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.
Arm Title
DSTA4637S high dose level+ SOC
Arm Type
Experimental
Arm 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.
Arm Title
Placebo + SOC
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
DSTA4637S
Intervention Description
DSTA4637S will be administered as an IV infusion at 3 dose levels.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matched to DSTA4637S IV infusion will be administered as specified.
Intervention Type
Drug
Intervention Name(s)
SOC
Intervention Description
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 Outcome Measure Information:
Title
Percentage of Participants With Adverse Events (AEs)
Time Frame
Baseline up to approximately 156 Days
Secondary Outcome Measure Information:
Title
Measure of Antibody-Conjugated 4-Dimethylamino Piperidino-Hydroxybenzoxazino Rifamycin (dmDNA31) measured by Plasma
Time Frame
Baseline up to approximately 156 Days
Title
Measure of DSTA4637S Total Antibody measured by Serum
Time Frame
Baseline up to approximately 156 Days
Title
Measure of Unconjugated dmDNA31 measured by Plasma
Time Frame
Baseline up to approximately 156 Days
Title
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to DSTA4637S
Time Frame
Baseline up to approximately 156 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Los Angeles Biomedical Research Institute at Harbor-UCLA
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Gyeongsang National University Hospital
City
Gyeongsangnam-do
ZIP/Postal Code
52727
Country
Korea, Republic of
Facility Name
Asan Medical Center - Oncology
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Hospital Universitario de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Mutua de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Participants With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care (SOC) Antibiotics
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