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NCT03162250 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Bacteremia, sponsored by Genentech.

Completed
Registry status
Phase 1
Development phase
27
Enrollment target
16
Study locations

NCT03162250 is a Phase 1 study of Bacteremia that has completed, run by Genentech. The registered enrollment target is 27 participants, below the 7,574-participant average among 11 other Bacteremia trials with a reported enrollment target (100% lower). The trial reports 16 study locations across 6 states.

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The verdict

NCT03162250, a Phase 1 study of Bacteremia, has completed, sponsored by Genentech.

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target
16
Study locations

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

Bacteremia

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

332 total trials

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What the Registry Record Tells You About NCT03162250

The ClinicalTrials.gov registry entry for NCT03162250 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,574-participant average among 11 other Bacteremia trials with a reported enrollment target (100% lower). The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.

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.

NCT03162250 reports 16 study locations spanning 6 distinct geographic areas - top geographies include Other, Michigan, Barcelona.

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.

What interventions are being tested in trial NCT03162250?

The interventions under investigation include: Placebo (DRUG), SOC (DRUG), DSTA4637S (DRUG).

Who is sponsoring clinical trial NCT03162250?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.