Ceftriaxone as Home IV for Staph Infections

  • STATUS
    Recruiting
  • End date
    Mar 30, 2024
  • participants needed
    310
  • sponsor
    Vancouver Island Health Authority
Updated on 16 February 2022
antibiotic therapy
antibiotics
ceftriaxone
abscess
methicillin
staphylococcus aureus
prosthetic joint infection
epidural abscess
cloxacillin
cefazolin
daptomycin
diabetic foot
septic arthritis
staphylococcus
foot infection
joint infection
other antibiotics
oxacillin

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.

Description

The use of ceftriaxone for deep-seated Staphylococcal infections requiring prolonged IV treatment is a practice that has already evolved both locally and globally despite the absence of high-quality clinical data. Retrospective studies that support the use of ceftriaxone for this indication, including those that currently inform Infectious Diseases Society of America (IDSA) guidelines, unanimously agree that prospective, randomized data is urgently needed. Our study is the next natural step in the research process and would greatly add to the body of evidence informing this practice by addressing current knowledge gaps. On a clinical level, demonstrating non-inferiority of ceftriaxone would allow its use in a population of patients currently ineligible for outpatient antibiotic treatment or in cases where broader, more expensive agents are currently employed. This would facilitate more rapid discharge from hospital, lead to substantial cost savings, and have a considerable impact on antimicrobial stewardship. Most importantly, it would improve the quality of life of patients by allowing them to be treated at home in cases when multi-dose home IV administration is a barrier to discharge. This study would address the need to support and harmonize current practice at Island Health, increase the level of evidence in current guidelines and improve patient care both locally and globally.

This is a prospective, randomized, controlled, unblinded trial with a pragmatic design. The goal is to assess whether the intervention is non-inferior to standard therapies in achieving the primary outcome. Patients will be drawn from inpatient populations and patients treated through an outpatient antibiotic therapy clinic who are eligible for further IV treatment through a home intravenous therapy program. Patients meeting inclusion criteria as described will be asked to participate and informed consent obtained. Once informed consent is obtained patients will be randomized to receive ceftriaxone or standard therapies (cloxacillin, cefazolin, daptomycin) as determined by the treating infectious diseases physician. Patients will have deep-seated infections such as:

  • Osteomyelitis
  • Native Joint Septic Arthritis
  • Prosthetic Joint Septic Arthritis
  • Central Nervous System Infection
  • Deep Tissue Infection
  • Diabetic Foot Infection

Infections will be confirmed to have been caused by methicillin-sensitive Staphylococcus aureus or a coagulase-negative Staphylococcal species through microbiological testing. Susceptibility testing will ensure that the isolate is susceptible to the study drug and at least one of the standard therapies.

Once the patient is randomized all other aspects of care will follow usual home IV therapy policies and procedures. Neither the patient nor the clinical team will be blinded to the study drug the patient is receiving. Duration of treatment will be decided by the treating infectious diseases clinician based on infection site and available guidelines. Baseline data will be collected by the study team at the time of randomization.

The patient will be followed up in the usual manner by their infectious diseases physician. Data will be collected in a standardized manner at the pre-specified end of antibiotic therapy. Clinical cure (primary outcome) will be determined based on this data.

Adverse event rates will be collected throughout the study period. At six months post-randomization the study team will assess for any markers of treatment failure (see secondary outcomes).

Plan for statistical analysis is pre-specified in the protocol and will be completed with the assistance of biostatistics staff at the University of Victoria. Specific information on the protection of patient confidentiality and data integrity is outlined in the study protocol. Ethics approval has been granted by the Clinical Research Ethics Board at Vancouver Island Health Authority.

Details
Condition Staphylococcal Infections, Osteomyelitis, CNS Infection, Septic Arthritis, Diabetic Foot Infection, Vertebral Osteomyelitis, Abscess, Coagulase Negative Staphylococcal Infection
Treatment ceftriaxone, Usual Antibiotics (Cloxacillin, Cefazolin, Daptomycin)
Clinical Study IdentifierNCT04141787
SponsorVancouver Island Health Authority
Last Modified on16 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

are 18 years of age or older
were referred to and assessed by an Infectious Disease physician in the form of a clinical consult as either
an inpatient at the Royal Jubilee or Victoria General Hospitals
an outpatient at the emergency department of one of the aforementioned hospitals
an outpatient at the Outpatient Parenteral Antibiotic Therapy (OPAT) clinic
have a clinically and/or radiographically diagnosed deep-seated MSSA or coagulase-negative Staphylococcal infection as defined in Table 1 of the protocol (Osteomyelitis, Discitis/Epidural abscess, Central Nervous System (CNS) infection, Abscess, Septic Arthritis (including Prosthetic Joint Infection), Diabetic foot infection) and the diagnosis has been made or confirmed by the Infectious Disease physician
have had the causative pathogen confirmed microbiologically as either MSSA or CoNS through a laboratory sample indicative of the current site of infection
are deemed to require prolonged IV antibiotic therapy and subsequently referred for assessment by the home IV program by the Infectious Disease physician
are an appropriate candidate for the home IV program as determined by the assessing Home IV nurse, and are eligible for treatment with BOTH ceftriaxone AND at least one of the usual alternatives, namely cloxacillin, cefazolin or daptomycin
provide written informed consent to participate in the study
have their culture and sensitivity results finalized prior to randomization, with the isolate confirmed to be sensitive to all study drugs (susceptibilities are discussed in the "Microbiological Testing" section of the protocol)
are successfully randomized to either ceftriaxone OR one of cloxacillin, cefazolin or daptomycin before Home IV orders are written (the choice between the three comparator antibiotics will be at the discretion of the treating Infectious Disease physician)
receive at least one dose of the antibiotic to which they were randomized prior to being discharged on the home IV program
are physically discharged to the home IV program for any duration

Exclusion Criteria

younger than 18 years of age
pregnant
involved in another therapeutic trial
are not under the care of an Infectious Disease physician
are unable to provide informed consent due to language or cognitive barriers
are not appropriate for Home IV therapy as determined by the assessing Home IV nurse
are concurrently receiving other anti-staphylococcal antibiotics (excluding the synergistic use of rifampin for prosthetic joint infections) at the time of discharge on the home IV program
have relevant cultures indicating a polymicrobial infection (except in the case of diabetic foot infections where they may be included if MSSA or CoNS is determined to be the dominant pathogen by the Infectious Disease physician and any additional antibiotics used do not exhibit activity against MSSA or CoNS)
have concurrent or incompletely treated bacteremia with MSSA or CoNS (as defined in protocol)
have infective endocarditis based on imaging or clinical judgement
are receiving home IV antibiotics solely as palliative therapy
are unable to tolerate ceftriaxone AND any ONE of the standardly used antibiotics (cloxacillin, cefazolin, daptomycin) because of an allergy or intolerance
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note