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Antibiotic Durations for Gram-negative Bacteremia

NCT03101072 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2019-11-19

No results posted yet for this study

Summary

Gram-negative bacteremia (GNB) is a frequent hospital \& community-acquired infection, yet there is as yet no evidence from randomized studies on the optimal duration of antibiotic therapy. This point-of-care, multicenter randomized controlled non-inferiority trial will randomize 500 patients with GNB on day 5 of appropriate antibiotic therapy to either (1) a total of 7 days of antibiotic therapy, (2) a total of 14 days of antibiotic therapy, or (3) an individualized duration of antibiotic therapy (guided by the patient's clinical course \& C-reactive protein levels). The primary outcome is the incidence of clinical failure at day 30.

Conditions

  • Bacteraemia Caused by Gram-Negative Bacteria

Interventions

OTHER

"Fixed long" antibiotic course of 14 days

Only the duration of antibiotic therapy will be investigated in this study. (In all arms, the choice and mode of administration (IV vs. PO) of antibiotic(s) will be left to the patient's attending physician and consulting infectious disease specialist and thus will follow usual standards of care.)

OTHER

"Fixed short" antibiotic course of 7 days

Only the duration of antibiotic therapy will be investigated in this study. (In all arms, the choice and mode of administration (IV vs. PO) of antibiotic(s) will be left to the patient's attending physician and consulting infectious disease specialist and thus will follow usual standards of care.)

OTHER

"Individualized duration" of antibiotic therapy

Only the duration of antibiotic therapy will be investigated in this study. (In all arms, the choice and mode of administration (IV vs. PO) of antibiotic(s) will be left to the patient's attending physician and consulting infectious disease specialist and thus will follow usual standards of care.)

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    collaborator OTHER

  • Cantonal Hospital of St. Gallen

    collaborator OTHER

  • University of Geneva, Switzerland

    lead OTHER

Principal Investigators

  • Angela Huttner, MD · University of Geneva

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-27
Primary Completion
2019-06-11
Completion
2019-08-26

Countries

  • Switzerland

Study Locations

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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 NCT03101072 on ClinicalTrials.gov