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RCT Cefiderocol vs BAT for Treatment of Gram Negative BSI

NCT03869437 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 513

Last updated 2024-02-13

No results posted yet for this study

Summary

The purpose of this study is to determine whether a new antibiotic, Cefiderocol which works against a wide variety of gram negative bacteria, is equally effective as the antibiotics that are currently used as current standard of care.

Conditions

Interventions

DRUG

Cefiderocol

2 grams intravenously administered over 3 hours every 8 hours for a period of 5 to 14 days (dosage adjustment is necessary based on renal function).

OTHER

Best Available Therapy

Standard of care was determined by the investigator

Sponsors & Collaborators

  • Shionogi

    collaborator INDUSTRY

  • The University of Queensland

    lead OTHER

Principal Investigators

  • David Paterson, Professor · The Univeristy of Queensland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-28
Primary Completion
2023-11-13
Completion
2024-01-29

Countries

  • Australia
  • Malaysia
  • Singapore
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03869437 on ClinicalTrials.gov