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Trial record 2 of 2 for:    DSTA4637S

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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ClinicalTrials.gov Identifier: NCT03162250
Recruitment Status : Recruiting
First Posted : May 22, 2017
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Bacteremia Drug: DSTA4637S Drug: Placebo Drug: SOC Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 13, 2017
Estimated Primary Completion Date : February 27, 2019
Estimated Study Completion Date : February 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: DSTA4637S low dose level + SOC
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
DSTA4637S will be administered as an IV infusion at 3 dose levels.

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

Experimental: DSTA4637S intermediate dose level+ SOC
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
DSTA4637S will be administered as an IV infusion at 3 dose levels.

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

Experimental: DSTA4637S high dose level+ SOC
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
DSTA4637S will be administered as an IV infusion at 3 dose levels.

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

Placebo Comparator: Placebo + SOC
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
Placebo matched to DSTA4637S IV infusion will be administered as specified.

Drug: SOC
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 Measures :
  1. Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to approximately 156 Days ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162250


Contacts
Contact: Reference Study ID Number: GV39131 www.roche.com/abo 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
United States, California
Los Angeles Biomedical Research Institute at Harbor-UCLA Recruiting
Torrance, California, United States, 90502
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Korea, Republic of
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of, 35015
Gyeongsang National University Hospital Recruiting
Gyeongsangnam-do, Korea, Republic of, 52727
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 08308
Spain
Hospital Universitario de Bellvitge Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Mutua de Terrassa Recruiting
Terrassa, Barcelona, Spain, 08221
Hospital Universitario Marques de Valdecilla Recruiting
Santander, Cantabria, Spain, 39008
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain, 41009
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Sponsors and Collaborators
Genentech, Inc.

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03162250     History of Changes
Other Study ID Numbers: GV39131
2016-001880-35 ( EudraCT Number )
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents