Ceftriaxone as Home IV for Staph Infections

Summary

Patients who are admitted to hospital with serious infections, such as those in bone, joints or spine, require a long course of intravenous (IV) antibiotics. After an initial treatment course in hospital or through a dedicated outpatient antibiotic program many patients can complete their treatment course at home. Such infections are often caused by bacteria called Staphylococci, and currently there are three antibiotic options used routinely. A fourth antibiotic, ceftriaxone, is a promising alternative; it is also effective against Staphylococci, and is more convenient, less costly and easier to give at home, however, it has not been studied thoroughly in a prospective manner. This study will compare ceftriaxone to routinely used antibiotics (cloxacillin, cefazolin or daptomycin) to see if ceftriaxone is equally as safe and efficacious in curing deep-seated Staphylococcal infections in patients receiving home IV antibiotics. Patients with deep-seated infections caused by methicillin-susceptible Staphylococcus aureus (MSSA) or coagulase-negative Staphylococcal species will be randomly assigned home IV treatment with ceftriaxone OR one of the three other antibiotics before leaving the hospital. Patients will then receive usual care from an Infectious Disease physician and Home IV team. The study team will assess whether cure has been achieved by the end of the IV treatment, follow-up at 6 months to see if patients remain infection-free, and record any side-effects of treatment. The overall goal is to determine whether ceftriaxone can be considered non-inferior to usual antibiotic treatment in treating Staphylococcal infections in a home IV setting.

Conditions

• Staphylococcal Infections
• Osteomyelitis
• CNS Infection
• Septic Arthritis
• Diabetic Foot Infection
• Vertebral Osteomyelitis
• Abscess
• Coagulase Negative Staphylococcal Infection

Interventions

DRUG

Ceftriaxone

Participants with methicillin-sensitive deep-seated staphylococcal infections eligible for treatment on home IV will be randomly assigned to a "treatment" group of ceftriaxone or "standard therapy/usual antibiotics" with either cloxacillin, cefazolin or daptomycin. The treatment with one of the three "standard therapies/usual antibiotics" will be left to the discretion of the treating Infectious Disease doctor, in line with current standards of practice.

DRUG

Usual Antibiotics (Cloxacillin, Cefazolin, Daptomycin)

Participants with methicillin-sensitive deep-seated staphylococcal infections eligible for treatment on home IV will be randomly assigned to a "treatment" group of ceftriaxone or "standard therapy/usual antibiotics" with either cloxacillin, cefazolin or daptomycin. The treatment with one of the three "standard therapies/usual antibiotics" will be left to the discretion of the treating Infectious Disease doctor, in line with current standards of practice.

Sponsors & Collaborators

• Vancouver Island Health Authority

  lead OTHER

Principal Investigators

• Eric Partlow, MD, FRCPC · Vancouver Island Health Authority

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-11

Primary Completion

2023-07-31

Completion

2024-03-30

Countries

• Canada

Study Locations