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

Bacteremia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162250
• Other study ID #: GV39131
• Secondary ID: 2016-001880-35
• Status: Completed
• Phase: Phase 1
• Start date: July 13, 2017
• Est. completion date: January 15, 2020

Study information

• Verified date: January 2020
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (MRSA) and methicillin-sensitive staphylococcus aureus (MSSA) bacteremia requiring at least 4 weeks of anti-staphylococcal SOC antibiotics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia

Intervention

Drug:
• DSTA4637S
DSTA4637S will be administered as an IV infusion at 3 dose levels.
• Placebo
Placebo matched to DSTA4637S IV infusion will be administered as specified.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events (AEs)		Baseline up to approximately 156 Days
Secondary	Measure of Antibody-Conjugated 4-Dimethylamino Piperidino-Hydroxybenzoxazino Rifamycin (dmDNA31) measured by Plasma		Baseline up to approximately 156 Days
Secondary	Measure of DSTA4637S Total Antibody measured by Serum		Baseline up to approximately 156 Days
Secondary	Measure of Unconjugated dmDNA31 measured by Plasma		Baseline up to approximately 156 Days
Secondary	Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to DSTA4637S		Baseline up to approximately 156 Days