What side effects are associated with this type of intervention?

Common treatments for Staph infections, including ceftriaxone, cloxacillin, cefazolin, and daptomycin, have several known side effects. Ceftriaxone can cause biliary sludge and gallstones, while cloxacillin and cefazolin may lead to gastrointestinal issues like nausea, vomiting, and diarrhea. Daptomycin is associated with muscle pain and elevated creatine phosphokinase levels. Additionally, beta-lactam antibiotics, in general, can cause allergic reactions, ranging from mild rashes to severe anaphylaxis. Monitoring for these side effects is crucial during treatment.

What prior FDA approvals exist?

The FDA has approved several antibiotics for the treatment of Staphylococcal infections, including cephalosporins like cefazolin and ceftriaxone, which are effective against methicillin-susceptible Staphylococcus aureus (MSSA). Additionally, ceftaroline, a newer cephalosporin, has been approved for treating methicillin-resistant Staphylococcus aureus (MRSA) infections. Other related antibiotics include daptomycin and linezolid, which are also used for treating MRSA. These antibiotics have been shown to be effective in treating various types of Staph infections, including those in the skin, bloodstream, and respiratory system.

What other types of research exist?

Promising novel alternatives to ceftriaxone for treating Staphylococcal infections include daptomycin, linezolid, and quinupristin/dalfopristin. These antibiotics have been shown to be effective in treating invasive Gram-positive infections, including those caused by Staphylococci, and have been studied for their safety and efficacy in pediatric and adult patients.

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Cephalosporin Antibiotic

Ceftriaxone for Staph Infection

Phase 4

Waitlist Available

Led By Eric Partlow, MD, FRCPC

Research Sponsored by Vancouver Island Health Authority

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are 18 years of age or older

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)

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months post-randomization

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

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%.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include allergic reactions to antibiotics such as rashes or itching; gastrointestinal issues like nausea or diarrhea; possible liver enzyme elevations; and less commonly blood disorders. The exact side effects will depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My infection is sensitive to all the drugs in this study.

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I am enrolled in a home IV program.

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I have a deep infection diagnosed by a specialist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am receiving IV antibiotics at home for comfort care.

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I am allergic or cannot tolerate ceftriaxone and one other common antibiotic.

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I have been diagnosed with infective endocarditis.

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I am under 18 years old.

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I currently have or recently had a bacterial infection in my blood.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at six months following randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at six months following randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and at six months following randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical cure rate of deep-seated methicillin sensitive Staphylococcal infections

Secondary study objectives

Adverse event rate

Treatment failure at six months post-randomization

Other study objectives

Duration of therapy

Rate of antibiotic substitution or discontinuation

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: CeftriaxoneActive Control1 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 Control1 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.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Ceftriaxone, a third-generation cephalosporin, works by inhibiting bacterial cell wall synthesis, leading to cell lysis and death. This is crucial for treating Staph infections as it effectively targets the bacteria responsible for the infection. Other common antibiotics for Staph infections include cloxacillin and cefazolin, which also inhibit cell wall synthesis, and daptomycin, which disrupts cell membrane function. These mechanisms are vital because they directly attack the bacteria, reducing the infection and preventing complications. Effective antibiotic treatment is essential for Staph infection patients to ensure rapid recovery and prevent the spread of infection.

Antibiotic management of outpatients with endocarditis due to penicillin-susceptible streptococci.[Evaluation of ceftriaxone (R013-9904) in the treatment of septicemia caused by gram-negative bacilli].Ceftaroline versus vancomycin for treatment of acute pulmonary exacerbations of cystic fibrosis in adults.