Clinical trial NCT03162250: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bacteremia
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-22
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Baseline up to approximately 156 Days
Secondary outcomes:
measure: Measure of Antibody-Conjugated 4-Dimethylamino Piperidino-Hydroxybenzoxazino Rifamycin (dmDNA31) measured by Plasma
timeFrame: Baseline up to approximately 156 Days
measure: Measure of DSTA4637S Total Antibody measured by Serum
timeFrame: Baseline up to approximately 156 Days
measure: Measure of Unconjugated dmDNA31 measured by Plasma
timeFrame: Baseline up to approximately 156 Days
measure: Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to DSTA4637S
timeFrame: Baseline up to approximately 156 Days
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute at Harbor-UCLA
state: California
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - Oncology
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
Study officials:
References: