Ceftriaxone for Staph Infection

Recruiting at1 trial location

Overseen by Eric Partlow, MD, FRCPC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Vancouver Island Health Authority

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing if ceftriaxone, an IV antibiotic, is as effective and safe as other antibiotics for treating serious bone, joint, or spine infections caused by Staphylococcal bacteria. Ceftriaxone could be a more convenient and less costly option for home treatment. Ceftriaxone has been evaluated for its efficacy and safety in treating serious infections, including bone and joint infections, with a clinical cure rate of 87%.

Research Team

Eric Partlow, MD, FRCPC

Principal Investigator

Vancouver Island Health Authority

Eligibility Criteria

Adults with serious Staph infections in bones, joints, or spine who can receive home IV treatment. They must have a confirmed diagnosis of MSSA or CoNS infection and be sensitive to the study drugs. Excluded are those under 18, pregnant women, participants in other trials, those with cognitive barriers to consent, polymicrobial infections (except certain diabetic foot infections), concurrent bacteremia, allergies to study drugs, not under an Infectious Disease physician's care or unsuitable for home IV therapy.

Inclusion Criteria

I need long-term IV antibiotics as recommended by an infectious disease doctor.

The specific germ causing the infection has been confirmed through a lab test.

I am eligible for home IV treatment with ceftriaxone and another antibiotic.

Exclusion Criteria

Are unable to provide informed consent due to language or cognitive barriers

I am receiving IV antibiotics at home for comfort care.

I am not taking other antibiotics for staph infections, except rifampin for a joint infection.

Treatment Details

Interventions

• Ceftriaxone (Cephalosporin Antibiotic)
• Usual Antibiotics (Cloxacillin, Cefazolin, Daptomycin) (Antibiotic)

Trial Overview The trial is testing if ceftriaxone is as safe and effective as usual antibiotics (cloxacillin, cefazolin or daptomycin) for treating deep-seated Staphylococcal infections at home. Patients will be randomly assigned either ceftriaxone or one of the standard antibiotics before leaving the hospital and monitored by healthcare professionals until treatment completion.

Participant Groups

Group I: Ceftriaxone Active Control 1 Intervention

Ceftriaxone 2g IV q24hvia Gravity (or q12h in the case of CNS infections) Duration dependent on site of infection, determined by treating infectious diseases (ID) clinicians based on accepted clinical guidelines.

Group II: Usual Antibiotics (Cloxacillin, Cefazolin, Daptomycin) Active Control 1 Intervention

"Usual Antibiotics" to treat methicillin-susceptible Staphylococcal infections * Cloxacillin 2g IV q4h via Pump (dose adjusted for renal function) * Cefazolin 2g IV q8h via Preloaded Syringe (dose adjusted for renal function) * Daptomycin 6-10mg/kg IV daily via Gravity (dose will be determined based on the severity of infection as per discretion of the ID clinician and in accordance with most recent evidence) * Duration dependent on site of infection, determined by treating infectious diseases clinicians based on accepted clinical guidelines.

Ceftriaxone is already approved in Canada for the following indications:

Approved in Canada as Rocephin for:

• Sepsis
• Bacterial infections
• Meningitis
• Gonorrhea
• Pelvic inflammatory disease
• Lower respiratory tract infections
• Skin and skin structure infections
• Urinary tract infections

Who Is Running the Clinical Trial?

Vancouver Island Health Authority

Lead Sponsor

Trials

17

Recruited

4,700+