Staphylococcal InfectionsPhase 4NCT04141787
Ceftriaxone as Home IV for Staph Infections
A Phase 4 study testing Ceftriaxone and Usual Antibiotics (Cloxacillin, Cefazolin, Daptomycin) in people with Staphylococcal Infections and Osteomyelitis, run by Vancouver Island Health Authority at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcal Infections, Osteomyelitis, CNS Infection
- What is being tested?
- Ceftriaxone and Usual Antibiotics (Cloxacillin, Cefazolin, Daptomycin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 2 sitesCanada
- Study dates
- 11 Jul 2019to 30 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Royal Jubilee Hospital
Victoria, British Columbia, V8R 1J8
Eric Partlow, MD, FRCPC, 778-404-0144, eric.partlow@viha.ca
Jolanta Pisczcek, Pharm D, MSc, 250-589-8507, jolanta.pisczcek@viha.ca
- Recruiting
Victoria General Hospital
Victoria, British Columbia, V8Z 6R5
Eric Partlow, MD, FRCPC, 778-404-0144, eric.partlow@viha.ca
Jolanta Pisczcek, Pharm D, MSc, 250-589-8507, jolanta.pisczcek@viha.ca
About this study
Official title: Ceftriaxone as Home Intravenous Therapy for Deep-Seated Staphylococcal Infections, a Randomized Non-Inferiority Trial
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.
Read the detailed 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.
- Conditions
- Staphylococcal Infections, Osteomyelitis, CNS Infection, Septic Arthritis, Diabetic Foot Infection, Vertebral Osteomyelitis
- Being tested
- Ceftriaxone, Usual Antibiotics (Cloxacillin, Cefazolin, Daptomycin)
- Keywords
- Ceftriaxone, Deep-seated Infections, Staphylococcus aureus, Coagulase-negative Staphylococcus species, MSSA, CoNS
- Medical subject headings
- Staphylococcal Infections, Osteomyelitis, Central Nervous System Infections, Arthritis, Infectious, Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftriaxoneDrug
Also called Rocephin
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.
Usual Antibiotics (Cloxacillin, Cefazolin, Daptomycin)Drug
Also called Cloxacillin, Cefazolin, Daptomycin, Ancef
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.
| Study group | Role | What they receive |
|---|---|---|
| Ceftriaxone | Active comparator | 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. Receives: Drug: Ceftriaxone |
| Usual Antibiotics (Cloxacillin, Cefazolin, Daptomycin) | Active comparator | "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. Receives: Drug: Usual Antibiotics (Cloxacillin, Cefazolin, Daptomycin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate of deep-seated methicillin sensitive Staphylococcal infections
Clinical cure of deep-seated MSSA and CoNS infections will be defined by improvement in clinical parameters, imaging findings and laboratory values at the time of completion of a pre-specified duration of antibiotic treatment based on infection site and clinical guidelines. Clinical cure defined by treating infectious diseases clinicians based on composite of:
- Resolution of signs and symptoms of deep-seated infection
- Improvement in inflammatory markers; defined as a C-reactive protein (CRP) less than 50% of initial CRP value
- Improvement in follow- up imaging when conducted, as determined by the interpreting radiologist
Measured: Up to 6 months post-randomization
Secondary outcomes (2)
Treatment failure at six months post-randomization
Failure of treatment at six months post-randomization will be defined by:
- Readmission to hospital for complications or progression of the specific infection being treated
- Need for further surgical source control procedures
- Additional antibiotics required for recurrent infection by the same organism, in the same location after initial treatment course was completed
This will be determined by chart review completed by study team members.
Measured: At six months following randomization
Adverse event rate
All adverse events related to study drug with specific safety data on rates of anaphylaxis, Clostridium difficile infections, dermatologic eruptions, hepatic enzyme abnormalities, leukopenia, thrombocytopenia, gastrointestinal upset and acute kidney injury between the two treatment arms.
Measured: Up to 6 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start11 Jul 2019
- Primary completionJul 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Staphylococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, unblinded non-inferiority trial being led by infectious diseases clinicians. We have chosen a pragmatic trial design which represents the most efficient use of available resources to test the study hypothesis and is the designed to determine effectiveness as opposed to efficacy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vancouver Island Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Partlow, Vancouver Island Health Authority
- Investigators
- Eric Partlow, MD, FRCPC, Principal investigator, Vancouver Island Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141787
- Sponsor's protocol ID
- C2018-018
- Status last verified
- Oct 2019
- First submitted
- 17 Oct 2019
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data for all primary and secondary outcome measures will be made available within 6 months of study completion.
Publications
Lother SA, Press N. Once-Daily Treatments for Methicillin-Susceptible Staphylococcus aureus Bacteremia: Are They Good Enough? Curr Infect Dis Rep. 2017 Sep 23;19(11):43. doi: 10.1007/s11908-017-0599-0.
PubMed 28942574Hotchkies L, Grima DT, Hedayati S. The total process cost of parenteral antibiotic therapy: beyond drug acquisition cost. Clin Ther. 1996 Jul-Aug;18(4):716-25; discussion 702. doi: 10.1016/s0149-2918(96)80222-0.
PubMed 8879899Patel UC, McKissic EL, Kasper D, Lentino JR, Pachucki CT, Lee T, Lopansri BK. Outcomes of ceftriaxone use compared to standard of therapy in methicillin susceptible staphylococcal aureus (MSSA) bloodstream infections. Int J Clin Pharm. 2014 Dec;36(6):1282-9. doi: 10.1007/s11096-014-9999-5. Epub 2014 Sep 4.
PubMed 25186790Wieland BW, Marcantoni JR, Bommarito KM, Warren DK, Marschall J. A retrospective comparison of ceftriaxone versus oxacillin for osteoarticular infections due to methicillin-susceptible Staphylococcus aureus. Clin Infect Dis. 2012 Mar 1;54(5):585-90. doi: 10.1093/cid/cir857. Epub 2011 Dec 5.
PubMed 22144536Winans SA, Luce AM, Hasbun R. Outpatient parenteral antimicrobial therapy for the treatment of methicillin-susceptible Staphylococcus aureus: a comparison of cefazolin and ceftriaxone. Infection. 2013 Aug;41(4):769-74. doi: 10.1007/s15010-013-0477-0. Epub 2013 May 19.
PubMed 23686435
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ceftriaxone as Home Intravenous Therapy for Deep-Seated Staphylococcal Infections, a Randomized Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT04141787
- Acronym / sponsor ID
- C2018-018
- Conditions
- Staphylococcal Infections, Osteomyelitis, CNS Infection, Septic Arthritis, Diabetic Foot Infection, Vertebral Osteomyelitis
- Keywords
- Ceftriaxone, Deep-seated Infections, Staphylococcus aureus, Coagulase-negative Staphylococcus species, MSSA, CoNS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Vancouver Island Health AuthorityUniversity, hospital or other
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, unblinded non-inferiority trial being led by infectious diseases clinicians. We have chosen a pragmatic trial design which represents the most efficient use of available resources to test the study hypothesis and is the designed to determine effectiveness as opposed to efficacy.
| Arm | Type | Receives |
|---|---|---|
| Ceftriaxone | Active comparator | Drug: CeftriaxoneCeftriaxone 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. |
| Usual Antibiotics (Cloxacillin, Cefazolin, Daptomycin) | Active comparator | Drug: Usual Antibiotics (Cloxacillin, Cefazolin, Daptomycin)"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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeftriaxoneAlso: RocephinParticipants 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 | Ceftriaxone |
| Usual Antibiotics (Cloxacillin, Cefazolin, Daptomycin)Also: Cloxacillin, Cefazolin, Daptomycin, AncefParticipants 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) |
Primary outcome
Clinical cure rate of deep-seated methicillin sensitive Staphylococcal infections
Time frame: Up to 6 months post-randomization
Clinical cure of deep-seated MSSA and CoNS infections will be defined by improvement in clinical parameters, imaging findings and laboratory values at the time of completion of a pre-specified duration of antibiotic treatment based on infection site and clinical guidelines. Clinical cure defined by treating infectious diseases clinicians based on composite of: * Resolution of signs and symptoms of deep-seated infection * Improvement in inflammatory markers; defined as a C-reactive protein (CRP) less than 50% of initial CRP value * Improvement in follow- up imaging when conducted, as determined by the interpreting radiologist
2 secondary outcomes
Treatment failure at six months post-randomization
Time frame: At six months following randomization
Adverse event rate
Time frame: Up to 6 months post-randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Background: PubMed 28942574Lother SA, Press N. Once-Daily Treatments for Methicillin-Susceptible Staphylococcus aureus Bacteremia: Are They Good Enough? Curr Infect Dis Rep. 2017 Sep 23;19(11):43. doi: 10.1007/s11908-017-0599-0.
- Background: PubMed 8879899Hotchkies L, Grima DT, Hedayati S. The total process cost of parenteral antibiotic therapy: beyond drug acquisition cost. Clin Ther. 1996 Jul-Aug;18(4):716-25; discussion 702. doi: 10.1016/s0149-2918(96)80222-0.
- Background: PubMed 25186790Patel UC, McKissic EL, Kasper D, Lentino JR, Pachucki CT, Lee T, Lopansri BK. Outcomes of ceftriaxone use compared to standard of therapy in methicillin susceptible staphylococcal aureus (MSSA) bloodstream infections. Int J Clin Pharm. 2014 Dec;36(6):1282-9. doi: 10.1007/s11096-014-9999-5. Epub 2014 Sep 4.
- Background: PubMed 22144536Wieland BW, Marcantoni JR, Bommarito KM, Warren DK, Marschall J. A retrospective comparison of ceftriaxone versus oxacillin for osteoarticular infections due to methicillin-susceptible Staphylococcus aureus. Clin Infect Dis. 2012 Mar 1;54(5):585-90. doi: 10.1093/cid/cir857. Epub 2011 Dec 5.
- Background: PubMed 23686435Winans SA, Luce AM, Hasbun R. Outpatient parenteral antimicrobial therapy for the treatment of methicillin-susceptible Staphylococcus aureus: a comparison of cefazolin and ceftriaxone. Infection. 2013 Aug;41(4):769-74. doi: 10.1007/s15010-013-0477-0. Epub 2013 May 19.
- Individual participant dataSharing planned: Yes. De-identified participant data for all primary and secondary outcome measures will be made available within 6 months of study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Partlow, MD, FRCPC principal investigator
Vancouver Island Health Authority
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ceftriaxone and Usual Antibiotics (Cloxacillin, Cefazolin, Daptomycin) in people with Staphylococcal Infections and Osteomyelitis, run by Vancouver Island Health Authority at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Partlow, MD, FRCPC (778-404-0144, eric.partlow@viha.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure rate of deep-seated methicillin sensitive Staphylococcal infections (time frame: Up to 6 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04141787, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2019.