Health Care Associated PneumoniaPhase 4STOP-NTNCT01734694
Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients
A Phase 4 study testing Vancomycin, Ceftaroline and Daptomycin in people with Health Care Associated Pneumonia and Osteomyelitis/Septic Arthritis, run by Henry Ford Health System at 1 site in United States.
Trial summary
For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical concern. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Care Associated Pneumonia, Osteomyelitis/Septic Arthritis, Endocarditis
- What is being tested?
- Vancomycin, Ceftaroline and Daptomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Sep 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Aged 18 years or older
- Receiving intravenous vancomycin for the treatment of healthcare associated pneumonia, osteomyelitis/septic arthritis, endocarditis/bacteremia, or acute bacterial skin and skin structure infections
- Expected to receive vancomycin for at least 72 hours and are within the first 72 hours of therapy
- Have at least two or more of the following risk factors for drug-induced nephrotoxicity: a) receipt high-dose vancomycin therapy (greater than or equal to four grams per day) b) receipt of vasopressors c) receipt of nephrotoxic drugs (i.e. aminoglycosides, furosemide, acyclovir, amphotericin b, colistin, and intravenous contrast dye) d) pre-existing renal dysfunction (i.e. SCr greater than or equal to 1.5 mg/dL).
Who cannot join
- Pregnancy
- End-stage renal disease
- Receipt of more than 4 grams of vancomycin prior to enrollment on current admission
- Absolute neutrophil count < 1000/mm3
Trial locations and contacts
1 site in 1 country.
About this study
For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical concern. This may be due to various reasons, including new dosing recommendations as well as an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity. This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin use.
- Conditions
- Health Care Associated Pneumonia, Osteomyelitis/Septic Arthritis, Endocarditis, Bacteremia, Acute Bacterial Skin and Skin Structure Infections
- Being tested
- Vancomycin, Ceftaroline, Daptomycin, Linezolid
- Medical subject headings
- Osteomyelitis, Arthritis, Infectious, Endocarditis, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;
Target trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;
CeftarolineDrug
Also called Teflaro
Dose based on package insert labeling
CrCL > 50 mL/min: 600 mg IV q12h
CrCL 31-50 mL/min: 400 mg q12h
CrCL 15-30 mL/min: 300 mg q12h
CrCL < 15mL/min: 200 mg q12h;
DaptomycinDrug
Also called Cubicin
Dose based on renal function and literature dosing recommendations
CrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h
CrCL < 30 mL/min: 6 - 10 mg/kg IV q48h
LinezolidDrug
Also called Zyvox
600 mg IV/PO q12h
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin | Active comparator | Not described Receives: Drug: Vancomycin |
| Comparator | Active comparator | Not described Receives: Drug: Ceftaroline; Drug: Daptomycin; Drug: Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Individuals With Nephrotoxicity
Increase in SCr of 0.5 mg/dL or 50% above baseline for at least two consecutive days while on the study drug and through discharge from hospital.
This measure will be reported as proportion of patients with nephrotoxicity within each group in relation to the number of patients in each group.
Measured: Day 1 and daily serum creatinine assessment up to date of discharge from hospital, and a median of 7 days.
Secondary outcomes (2)
Proportion of Individuals With Acute Kidney Injury Network Modified Definition of Nephrotoxicity
An abrupt (within 48 hour) reduction in kidney function with one or more of the following 1) Increase in SCr ≥ 0.3 mg/dL 2) Increase SCr ≥ 50% or 3) Decreased urine output (< 0.5 ml/kg/hr x 6 hrs) while on the study drug.
This measure will be reported as proportion of patients with acute kidney injury within each group in relation to the number of patients in each group.
Measured: Day 1 and daily serum creatinine assessment up to date of discharge, and a median of 7 days.
Proportion of Individuals With Clinical Success
Clinical success is a composite endpoint of those patients with clinical cure or improvement in clinical signs and symptoms of infection (i.e. SIRS criteria, and microbiology) while on the study drug.
This measure will be reported as the proportion of patients with clinical success in each group compared to the the total number of patients in the group.
Measured: Daily assessment of signs and symptoms of infection, and a median of 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startOct 2011
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Independent biostatistician recommended early termination of the trial due to low probability of success.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Health Care Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Vazquez, Henry Ford Health System
- Investigators
- Jose Vazquez, M.D., Principal investigator, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734694
- Sponsor's protocol ID
- 7089
- Acronym
- STOP-NT
- Status last verified
- Apr 2023
- First submitted
- 14 Nov 2012
- Last updated
- 3 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients
- ClinicalTrials.gov ID
- NCT01734694
- Acronym / sponsor ID
- STOP-NT / 7089
- Conditions
- Health Care Associated Pneumonia, Osteomyelitis/Septic Arthritis, Endocarditis, Bacteremia, Acute Bacterial Skin and Skin Structure Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Independent biostatistician recommended early termination of the trial due to low probability of success.
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Oct 2011 (actual)
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Posted 3 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical concern. This may be due to various reasons, including new dosing recommendations as well as an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity. This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin | Active comparator | Drug: Vancomycin |
| Comparator | Active comparator | Drug: Ceftaroline, Drug: Daptomycin, Drug: Linezolid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Receiving intravenous vancomycin for the treatment of healthcare associated pneumonia, osteomyelitis/septic arthritis, endocarditis/bacteremia, or acute bacterial skin and skin structure infections
- Expected to receive vancomycin for at least 72 hours and are within the first 72 hours of therapy
- Have at least two or more of the following risk factors for drug-induced nephrotoxicity: a) receipt high-dose vancomycin therapy (greater than or equal to four grams per day) b) receipt of vasopressors c) receipt of nephrotoxic drugs (i.e. aminoglycosides, furosemide, acyclovir, amphotericin b, colistin, and intravenous contrast dye) d) pre-existing renal dysfunction (i.e. SCr greater than or equal to 1.5 mg/dL).
Key exclusion criteria (4 listed)
- Pregnancy
- End-stage renal disease
- Receipt of more than 4 grams of vancomycin prior to enrollment on current admission
- Absolute neutrophil count < 1000/mm3
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 |
|---|---|---|
| VancomycinDose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia; Target trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections; | Drug | Vancomycin |
| CeftarolineAlso: TeflaroDose based on package insert labeling CrCL > 50 mL/min: 600 mg IV q12h CrCL 31-50 mL/min: 400 mg q12h CrCL 15-30 mL/min: 300 mg q12h CrCL < 15mL/min: 200 mg q12h; | Drug | Comparator |
| DaptomycinAlso: CubicinDose based on renal function and literature dosing recommendations CrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h CrCL < 30 mL/min: 6 - 10 mg/kg IV q48h | Drug | Comparator |
| LinezolidAlso: Zyvox600 mg IV/PO q12h | Drug | Comparator |
Primary outcome
Proportion of Individuals With Nephrotoxicity
Time frame: Day 1 and daily serum creatinine assessment up to date of discharge from hospital, and a median of 7 days.
Increase in SCr of 0.5 mg/dL or 50% above baseline for at least two consecutive days while on the study drug and through discharge from hospital. This measure will be reported as proportion of patients with nephrotoxicity within each group in relation to the number of patients in each group.
2 secondary outcomes
Proportion of Individuals With Acute Kidney Injury Network Modified Definition of Nephrotoxicity
Time frame: Day 1 and daily serum creatinine assessment up to date of discharge, and a median of 7 days.
Proportion of Individuals With Clinical Success
Time frame: Daily assessment of signs and symptoms of infection, and a median of 7 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Health Care Associated Pneumonia
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruiting
Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
Ventilator-Associated Pneumonia
Recruiting
Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
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.
Jose Vazquez, M.D. principal investigator
Henry Ford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vancomycin, Ceftaroline and Daptomycin in people with Health Care Associated Pneumonia and Osteomyelitis/Septic Arthritis, run by Henry Ford Health System at 1 site in United States.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 3 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Individuals With Nephrotoxicity (time frame: Day 1 and daily serum creatinine assessment up to date of discharge from hospital, and a median of 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2023.