BacteremiaPhase 1NCT03162250
Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Participants With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care (SOC) Antibiotics
A Phase 1 study testing DSTA4637S and SOC in people with Bacteremia, run by Genentech, Inc. at 16 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bacteremia
- What is being tested?
- DSTA4637S and SOC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 13 Jul 2017to 15 Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
Spain8 sites
Hospital del Mar
Barcelona, 08003
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital Mutua de Terrassa
Terrassa, Barcelona, 08221
United States4 sites
Henry Ford Health System
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27705
William Beaumont Hospital
Royal Oak, Michigan, 48073
Los Angeles Biomedical Research Institute at Harbor-UCLA
Torrance, California, 90502
South Korea4 sites
Chungnam National University Hospital
Daejeon, 35015
Gyeongsang National University Hospital
Gyeongsangnam-do, 52727
Asan Medical Center - Oncology
Seoul, 05505
Korea University Guro Hospital
Seoul, 08308
About this study
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
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.
- Conditions
- Bacteremia
- Being tested
- DSTA4637S, Placebo, SOC
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSTA4637SDrug
DSTA4637S will be administered as an IV infusion at 3 dose levels.
PlaceboDrug
Placebo matched to DSTA4637S IV infusion will be administered as specified.
SOCDrug
Anti-staphylococcal SOC antibiotics dosage and duration of therapy will be based on relevant health-authority approved indications and local and national treatment guidelines.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo; Drug: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs)
Measured: Baseline up to approximately 156 Days
Secondary outcomes (4)
Measure of Antibody-Conjugated 4-Dimethylamino Piperidino-Hydroxybenzoxazino Rifamycin (dmDNA31) measured by Plasma
Measured: Baseline up to approximately 156 Days
Measure of DSTA4637S Total Antibody measured by Serum
Measured: Baseline up to approximately 156 Days
Measure of Unconjugated dmDNA31 measured by Plasma
Measured: Baseline up to approximately 156 Days
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to DSTA4637S
Measured: Baseline up to approximately 156 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start13 Jul 2017
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162250
- Sponsor's protocol ID
- GV39131
- Other IDs
- 2016-001880-35, 2016
- Status last verified
- Jan 2020
- First submitted
- 26 Apr 2017
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03162250
- Acronym / sponsor ID
- GV39131
- Conditions
- Bacteremia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DSTA4637S low dose level + SOC | Experimental | Drug: DSTA4637S, Drug: SOCDSTA4637S 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+ SOC | Experimental | Drug: DSTA4637S, Drug: SOCDSTA4637S 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+ SOC | Experimental | Drug: DSTA4637S, Drug: SOCDSTA4637S 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 + SOC | Placebo comparator | Drug: Placebo, Drug: SOCPlacebo 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DSTA4637SDSTA4637S will be administered as an IV infusion at 3 dose levels. | Drug | DSTA4637S high dose level+ SOC, DSTA4637S intermediate dose level+ SOC, DSTA4637S low dose level + SOC |
| PlaceboPlacebo matched to DSTA4637S IV infusion will be administered as specified. | Drug | Placebo + SOC |
| SOCAnti-staphylococcal SOC antibiotics dosage and duration of therapy will be based on relevant health-authority approved indications and local and national treatment guidelines. | Drug | DSTA4637S high dose level+ SOC, DSTA4637S intermediate dose level+ SOC, DSTA4637S low dose level + SOC, Placebo + SOC |
Primary outcome
Percentage of Participants With Adverse Events (AEs)
Time frame: Baseline up to approximately 156 Days
4 secondary outcomes
Measure of Antibody-Conjugated 4-Dimethylamino Piperidino-Hydroxybenzoxazino Rifamycin (dmDNA31) measured by Plasma
Time frame: Baseline up to approximately 156 Days
Measure of DSTA4637S Total Antibody measured by Serum
Time frame: Baseline up to approximately 156 Days
Measure of Unconjugated dmDNA31 measured by Plasma
Time frame: Baseline up to approximately 156 Days
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to DSTA4637S
Time frame: Baseline up to approximately 156 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
Related trials for Bacteremia
RecruitingObservational study
Study of the Nasal Intracellular Reservoir of Staphylococcus Aureus in Patients With S. Aureus Bacteremia
Bacteria Infection Mechanism
Not yet recruitingPhase 4
Oral Switch in Bloodstream Infections in Immunocompromised Children
Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter
Not yet recruiting
Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers
Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DSTA4637S and SOC in people with Bacteremia, run by Genentech, Inc. at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain, United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (AEs) (time frame: Baseline up to approximately 156 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.