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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months post-randomization
Awards & highlights
Study Summary
This trial is comparing the effectiveness of a new antibiotic, ceftriaxone, to three other antibiotics that are routinely used, in treating patients with deep-seated infections caused by methicillin-susceptible Staphylococcus aureus (MSSA) or coagulase-negative Staphylococcal species.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical cure rate of deep-seated methicillin sensitive Staphylococcal infections
Secondary outcome measures
Adverse event rate
Treatment failure at six months post-randomization
Other outcome measures
Duration of therapy
Rate of antibiotic substitution or discontinuation
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.
Find a Location
Who is running the clinical trial?
Vancouver Island Health AuthorityLead Sponsor
16 Previous Clinical Trials
4,282 Total Patients Enrolled
Eric Partlow, MD, FRCPCPrincipal InvestigatorVancouver Island Health Authority
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 receiving IV antibiotics at home for comfort care.I am not taking other antibiotics for staph infections, except rifampin for a joint infection.I am allergic or cannot tolerate ceftriaxone and one other common antibiotic.I am eligible for home IV treatment with ceftriaxone and another antibiotic.I have been diagnosed with infective endocarditis.I was evaluated by an Infectious Disease doctor at specified locations.I received at least one dose of the assigned antibiotic before starting the home IV program.You have a type of infection caused by multiple different types of germs, unless it's a foot infection related to diabetes where specific germs are identified and the doctor agrees.I am 18 years old or older.I am under 18 years old.I have been assigned to receive either ceftriaxone or another specific antibiotic as part of my treatment.I currently have or recently had a bacterial infection in my blood.My infection is sensitive to all the drugs in this study.I have been deemed unsuitable for home IV therapy by a nurse.I am enrolled in a home IV program.I have a deep infection diagnosed by a specialist.
Research Study Groups:
This trial has the following groups:- Group 1: Ceftriaxone
- Group 2: Usual Antibiotics (Cloxacillin, Cefazolin, Daptomycin)
Awards:
This trial has 5 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Ceftriaxone for use in medical treatments?
"Clinical data confirms that ceftriaxone is a safe treatment option, thus it has been rated 3 on our scale. This falls in line with its Phase 4 status which implies regulatory approval."
Answered by AI
Are there still vacancies within this medical trial for participants?
"Clinicaltrials.gov verifies that this experiment is actively recruiting participants, with its initial posting date of July 11th 2019 and the last edit made on October 25th 2019."
Answered by AI
Has Ceftriaxone been employed in other medical experiments?
"As of today, 37 Ceftriaxone studies are underway with 9 at Phase 3. Most research is taking place in Philadelphia but there are 603 other sites conducting trials for this medication around the world."
Answered by AI
What is the cap on total participant numbers for this trial?
"Affirmative. Information on clinicaltrials.gov confirms that this trial, initially posted in July 2019, is actively recruiting participants. It requires 310 people from 2 different sites to take part in the study."
Answered by AI
What conditions is Ceftriaxone commonly employed to address?
"Physicians most often utilize ceftriaxone to treat intraabdominal infections, but it can be administered for other maladies including bacterial infections, staphylococcus aureus bloodstream infection (bsi; bacteremia), and postoperative prophylaxis."
Answered by AI
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