Staphylococcus Aureus Bacteremia Antibiotic Treatment Options

NCT01792804 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2020-05-27

No results posted yet for this study

Summary

Increasing resistance to antibiotic agents has been recognized as a major health problem worldwide that will even aggravate due to the lack of new antimicrobial agents within the next decade \[1\]. This threat underscores the need to maximize clinical utility of existing antibiotics, through more rational prescription, e.g. optimizing duration of treatment.

Staphylococcus aureus bloodstream infection (SAB) is a common disease with about 200,000 cases occurring annually in Europe \[2\]. A course of at least 14 days of intravenous antimicrobials is considered standard therapy \[3-5\] in "uncomplicated" SAB. This relatively long course serves to prevent SAB-related complications (such as endocarditis and vertebral osteomyelitis) that may result from hematogenous dissemination to distant sites. However, there is insufficient evidence that a full course of intravenous antibiotic therapy is always required in patients with a low risk of SAB-related complications.

In a multicenter, open-label, randomized controlled trial we aim to demonstrate that an early switch from intravenous to oral antimicrobial therapy is non-inferior to a conventional 14-days course of intravenous therapy regarding efficacy and safety. An early switch from intravenous to oral therapy would provide several benefits such as earlier discharge, fewer adverse reactions associated with intravenous therapy, increased quality of life, and cost savings.

Conditions

  • Staphylococcus Aureus Infection

Interventions

DRUG

Trimethoprim-Sulfamethoxazole

study drug 1

DRUG

Clindamycin

study drug 2

DRUG

Linezolid

study drug 3

DRUG

Flucloxacillin

study drug 4

DRUG

Cloxacillin

study drug 5

DRUG

Vancomycin

study drug 6

DRUG

Daptomycin

study drug 7

DRUG

Cefazolin

study drug 8

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER
  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Achim J Kaasch, MD · Heinrich-Heine University, Duesseldorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2020-03-26
Completion
2020-03-26

Countries

  • France
  • Germany
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01792804 on ClinicalTrials.gov