A study to look at how safe different doses of a new medicine called “DSTA4637S” were for patients – and how this medicine was processed through the body

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

Infectious Diseases
Bacterial Infection

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Basic Details

Gender

All

Age

≥ 18 Years & ≤ 80 Years

Healthy Volunteers

Sponsor Genentech, Inc.

Phase Phase 1

Study Identifier NCT03162250, GV39131, 2016-001880-35

This clinical trial was done to study a new medicine called, “DSTA4637S”, for the treatment of patients with infections caused by bacteria named Staphylococcus aureus. This study investigated the side effects caused by this medicine. Researchers were also interested to find out what happens to the medicine inside the body of patients. Twenty-five patients with S. aureus infection took part in the study at 17 study centers in 3 countries.

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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Basic Details

Sponsor Genentech, Inc.

Phase Phase 1

Trial Identifier NCT03162250, GV39131, 2016-001880-35

Condition Bacteremia

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 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

Gender

All

Age

≥ 18 Years & ≤ 80 Years

Healthy Volunteers

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

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

A study to look at how safe different doses of a new medicine called “DSTA4637S” were for patients – and how this medicine was processed through the body

Basic Details

What you can do next

What is Clinical Research?

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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Find participating medical centers and current study status in each of them

A study to look at how safe different doses of a new medicine called “DSTA4637S” were for patients – and how this medicine was processed through the body

Basic Details

What you can do next

Find participating medical centers and current study status in each of them

Explore related studies

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com