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COMPLETED Phase 1

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

NCT03162250 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG SOC
  • DRUG DSTA4637S

Study Locations (16)

Other

  • Chungnam National University Hospital — Daejeon
  • Gyeongsang National University Hospital — Gyeongsangnam-do
  • Asan Medical Center - Oncology — Seoul
  • Korea University Guro Hospital — Seoul
  • Hospital del Mar — Barcelona
  • Hospital Clinic de Barcelona — Barcelona
  • Hospital Universitario Ramon y Cajal — Madrid
  • Hospital Universitario Virgen Macarena — Seville
  • Hospital Universitario Virgen del Rocio — Seville

Michigan

  • Henry Ford Health System — Detroit
  • William Beaumont Hospital — Royal Oak

Barcelona

  • Hospital Universitario de Bellvitge — L'Hospitalet de Llobregat
  • Hospital Mutua de Terrassa — Terrassa

California

  • Los Angeles Biomedical Research Institute at Harbor-UCLA — Torrance

North Carolina

  • Duke University Medical Center — Durham

Cantabria

  • Hospital Universitario Marques de Valdecilla — Santander

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2017-07-13
Est. Completion 2020-01-15
Phase Phase 1

Sponsor

Genentech

206 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03162250

The ClinicalTrials.gov registry entry for NCT03162250 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 206 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Bacteremia appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03162250 reports 16 study locations spanning 6 distinct geographic areas — top geographies include Other, Michigan, Barcelona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03162250 about?

NCT03162250 is a clinical study titled "Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Participants With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care (SOC) 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 staphylo...

What is the current status of trial NCT03162250?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2017-07-13. Estimated completion is 2020-01-15.

What conditions does trial NCT03162250 study?

This clinical trial studies the following conditions: Bacteremia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03162250?

The interventions under investigation include: Placebo (DRUG), SOC (DRUG), DSTA4637S (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03162250?

This trial is sponsored by Genentech, which has 206 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03162250 being conducted?

This trial has 16 study locations across California, Michigan, North Carolina, Barcelona, Cantabria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial