PneumoniaNCT03586362
Vancomycin De-escalation Therapy in Patients With Pneumonia
An observational study of Pneumonia, run by CAMC Health System at 1 site in United States.
Trial summary
This is a non-inferiority study evaluating clinical improvement rate when using MRSA nasal swabs to guide discontinuation of vancomycin for empiric coverage for MRSA pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- How many people
- 278 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2018to 11 Sep 2023
- Phase
- Observational
- 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
Study population: All patients admitted to Charleston Area Medical Center through the Emergency Department with a diagnosis of pneumonia will be evaluated for potential enrollment.
Who may be able to join
- Age >= 18 years old
- Patients admitted to Charleston Area Medical Center (CAMC) through the Emergency Department who meet the CDC criteria for pneumonia.
- Nasal surveillance culture for MRSA obtained in the Emergency Department
- Patients receiving vancomycin and additional antibiotic therapy for gram-negative coverage
Who cannot join
- Persistent vasopressor requirements when MRSA nasal swab results are available
- Patients not meeting the CDC criteria for pneumonia
- Patients presenting to the ED with leukopenia (≤4000) without previous documentation of normal or elevated WBC
- Patients receiving empiric MRSA antibiotic therapy other than vancomycin for pneumonia
- Patients with the diagnosis of lung abscess
- Patients not receiving vancomycin therapy before MRSA nasal swab results are reported
Show all 11Show fewer
- Immunocompromised individuals. i.e. patients with AIDS/HIV, vasculitis on immune suppressor therapy, steroid therapy for more than one week prior admission or who received chemotherapy in the last 3 months
- Patients who do not have a MRSA nasal swab obtained in the ED
- Nares swab obtained after the completion of the first administered dose of an antibiotic with activity against MRSA
- Patients with MRSA bacteremia
- Patients with chronic tracheostomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Charleston Area Medical Center
Charleston, West Virginia, 25304
About this study
Official title: Vancomycin De-escalation Therapy in Patients With Pneumonia and Negative MRSA Nasal Swab
This is a non-inferiority study evaluating clinical improvement rate when using MRSA nasal swabs to guide discontinuation of vancomycin for empiric coverage for MRSA pneumonia.
Read the detailed description
Current clinical guidelines recommend including vancomycin in initial empiric therapy if risk factors for MRSA infection are present, or there is a high incidence of MRSA locally. Prolonged exposure to vancomycin, however, has been linked with the risk of vancomycin-associated kidney failure. Studies have reported that a MRSA nasal swab may be used to predict the presence of MRSA pneumonia. Specifically, pneumonia patients with negative MRSA nasal swabs are 95-99% likely to not have pneumonia due to MRSA. There is limited data, however, evaluating the use of a MRSA nasal swab to guide vancomycin therapy. Accordingly, in this study, pneumonia patients in the intervention arm will have empiric vancomycin discontinued following a negative MRSA nasal swab. In the control arm, patients vancomycin will not be discontinued based on the MRSA nasal swab result. The rate of clinical resolution will be compared between these two study arms.
- Conditions
- Pneumonia
- Keywords
- Vancomycin, MRSA nasal swab, Pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Patients admitted for pneumonia whose MRSA nasal swab is negative for MRSA, and empiric vancomycin is discontinued within 24 hours of the MRSA nasal swab results being documented in the electronic health record. | |
| Treatment Group B | Patients admitted for pneumonia whose empiric vancomycin is continued for ≥24 hours after electronic health record documentation of negative MRSA nasal swab results. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Clinical Improvement
Rate of clinical improvement following 7 days of antibiotic therapy for pneumonia. Clinical improvement rate is defined as the percentage of patients who had clinical documentation of improvement or resolution of all clinical signs and symptoms of pneumonia present at the time of pneumonia diagnosis.
- Afebrile: Temperature <38.0ºC or <100.4ºF
- Improvement of respiratory symptoms and signs per clinical documentation: cough, dyspnea, tachypnea, purulent sputum, increase respiratory secretions, increased suctioning requirements
- White blood count (WBC) trending down by at least 25%, or when baseline was≤ 15,000 mm3, or return to the normal values
- Less oxygen supplementation and ventilation
- Chest radiographic improvement per radiologist report (e.g. infiltrate, consolidation or cavitation)
Measured: Evaluation will be completed 48 hours after 7 days of antibiotic therapy for pneumonia.
Secondary outcomes (5)
Hospital Length of Stay
Date of admission to date of discharge from the hospital
Measured: During patient hospital stay for up to 6 months
In-hospital mortality
Number of deaths
Measured: During patient hospital stay for up to 6 months
Rate of vancomycin-associated kidney injury defined as a 50% increase in serum creatinine or at least two consecutive increases in serum creatinine by 0.5 mg/dL after at least 48 hours of vancomycin therapy.
Number of kidney injuries following administration of vancomycin
Measured: Time between vancomycin administration and discharge from hospital for up to 6 months.
Hospital complications, such as MRSA bacteremia and septic shock
Number of MRSA bacteremia and septic shock patients whose MRSA nasal swab is negative and have MRSA pneumonia
Measured: During patient hospital stay for up tp 6 months
Billing cost associated with vancomycin therapy and laboratory monitoring
Total charges associated with vancomycin therapy and laboratory monitoring
Measured: During patient hospital stay for up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start8 Feb 2018
- Primary completion11 Sep 2023
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rayan Ihle, CAMC Health System
- Investigators
- Audis Bethea, PharmD, BCPS, Principal investigator, CAMC Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586362
- Sponsor's protocol ID
- 17-406
- Status last verified
- Aug 2026
- First submitted
- 3 Jul 2018
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Edwards JR, Peterson KD, Andrus ML, Dudeck MA, Pollock DA, Horan TC; National Healthcare Safety Network Facilities. National Healthcare Safety Network (NHSN) Report, data summary for 2006 through 2007, issued November 2008. Am J Infect Control. 2008 Nov;36(9):609-26. doi: 10.1016/j.ajic.2008.08.001. No abstract available.
PubMed 18992647Greenaway CA, Embil J, Orr PH, McLeod J, Dyck B, Nicolle LE. Nosocomial pneumonia on general medical and surgical wards in a tertiary-care hospital. Infect Control Hosp Epidemiol. 1997 Nov;18(11):749-56. doi: 10.1086/647529.
PubMed 9397368Cook DJ, Kollef MH. Risk factors for ICU-acquired pneumonia. JAMA. 1998 May 27;279(20):1605-6. doi: 10.1001/jama.279.20.1605. No abstract available.
PubMed 9613899Craven DE, Steger KA. Epidemiology of nosocomial pneumonia. New perspectives on an old disease. Chest. 1995 Aug;108(2 Suppl):1S-16S. doi: 10.1378/chest.108.2_supplement.1s. No abstract available.
PubMed 7634921Zimlichman E, Henderson D, Tamir O, Franz C, Song P, Yamin CK, Keohane C, Denham CR, Bates DW. Health care-associated infections: a meta-analysis of costs and financial impact on the US health care system. JAMA Intern Med. 2013 Dec 9-23;173(22):2039-46. doi: 10.1001/jamainternmed.2013.9763.
PubMed 23999949Rubinstein E, Kollef MH, Nathwani D. Pneumonia caused by methicillin-resistant Staphylococcus aureus. Clin Infect Dis. 2008 Jun 1;46 Suppl 5:S378-85. doi: 10.1086/533594.
PubMed 18462093Liu C, Bayer A, Cosgrove SE, Daum RS, Fridkin SK, Gorwitz RJ, Kaplan SL, Karchmer AW, Levine DP, Murray BE, J Rybak M, Talan DA, Chambers HF; Infectious Diseases Society of America. Clinical practice guidelines by the infectious diseases society of america for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011 Feb 1;52(3):e18-55. doi: 10.1093/cid/ciq146. Epub 2011 Jan 4.
PubMed 21208910Erb CT, Patel B, Orr JE, Bice T, Richards JB, Metersky ML, Wilson KC, Thomson CC. Management of Adults with Hospital-acquired and Ventilator-associated Pneumonia. Ann Am Thorac Soc. 2016 Dec;13(12):2258-2260. doi: 10.1513/AnnalsATS.201608-641CME. No abstract available.
PubMed 27925784van Hal SJ, Paterson DL, Lodise TP. Systematic review and meta-analysis of vancomycin-induced nephrotoxicity associated with dosing schedules that maintain troughs between 15 and 20 milligrams per liter. Antimicrob Agents Chemother. 2013 Feb;57(2):734-44. doi: 10.1128/AAC.01568-12. Epub 2012 Nov 19.
PubMed 23165462Harigaya Y, Bulitta JB, Forrest A, Sakoulas G, Lesse AJ, Mylotte JM, Tsuji BT. Pharmacodynamics of vancomycin at simulated epithelial lining fluid concentrations against methicillin-resistant Staphylococcus aureus (MRSA): implications for dosing in MRSA pneumonia. Antimicrob Agents Chemother. 2009 Sep;53(9):3894-901. doi: 10.1128/AAC.01585-08. Epub 2009 Jul 13.
PubMed 19596879Rybak M, Lomaestro B, Rotschafer JC, Moellering R Jr, Craig W, Billeter M, Dalovisio JR, Levine DP. Therapeutic monitoring of vancomycin in adult patients: a consensus review of the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2009 Jan 1;66(1):82-98. doi: 10.2146/ajhp080434. No abstract available.
PubMed 19106348Minejima E, Choi J, Beringer P, Lou M, Tse E, Wong-Beringer A. Applying new diagnostic criteria for acute kidney injury to facilitate early identification of nephrotoxicity in vancomycin-treated patients. Antimicrob Agents Chemother. 2011 Jul;55(7):3278-83. doi: 10.1128/AAC.00173-11. Epub 2011 May 16.
PubMed 21576448Hazlewood KA, Brouse SD, Pitcher WD, Hall RG. Vancomycin-associated nephrotoxicity: grave concern or death by character assassination? Am J Med. 2010 Feb;123(2):182.e1-7. doi: 10.1016/j.amjmed.2009.05.031.
PubMed 20103028Hiramatsu K, Hanaki H, Ino T, Yabuta K, Oguri T, Tenover FC. Methicillin-resistant Staphylococcus aureus clinical strain with reduced vancomycin susceptibility. J Antimicrob Chemother. 1997 Jul;40(1):135-6. doi: 10.1093/jac/40.1.135. No abstract available.
PubMed 9249217Pitz AM, Yu F, Hermsen ED, Rupp ME, Fey PD, Olsen KM. Vancomycin susceptibility trends and prevalence of heterogeneous vancomycin-intermediate Staphylococcus aureus in clinical methicillin-resistant S. aureus isolates. J Clin Microbiol. 2011 Jan;49(1):269-74. doi: 10.1128/JCM.00914-10. Epub 2010 Oct 20.
PubMed 20962147
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vancomycin De-escalation Therapy in Patients With Pneumonia and Negative MRSA Nasal Swab
- ClinicalTrials.gov ID
- NCT03586362
- Acronym / sponsor ID
- 17-406
- Conditions
- Pneumonia
- Keywords
- Vancomycin, MRSA nasal swab, Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 13 Jul 2018 (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.
This is a non-inferiority study evaluating clinical improvement rate when using MRSA nasal swabs to guide discontinuation of vancomycin for empiric coverage for MRSA pneumonia.
Detailed description
Current clinical guidelines recommend including vancomycin in initial empiric therapy if risk factors for MRSA infection are present, or there is a high incidence of MRSA locally. Prolonged exposure to vancomycin, however, has been linked with the risk of vancomycin-associated kidney failure. Studies have reported that a MRSA nasal swab may be used to predict the presence of MRSA pneumonia. Specifically, pneumonia patients with negative MRSA nasal swabs are 95-99% likely to not have pneumonia due to MRSA. There is limited data, however, evaluating the use of a MRSA nasal swab to guide vancomycin therapy. Accordingly, in this study, pneumonia patients in the intervention arm will have empiric vancomycin discontinued following a negative MRSA nasal swab. In the control arm, patients vancomycin will not be discontinued based on the MRSA nasal swab result. The rate of clinical resolution will be compared between these two study arms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | – | –Patients admitted for pneumonia whose MRSA nasal swab is negative for MRSA, and empiric vancomycin is discontinued within 24 hours of the MRSA nasal swab results being documented in the electronic health record. |
| Treatment Group B | – | –Patients admitted for pneumonia whose empiric vancomycin is continued for ≥24 hours after electronic health record documentation of negative MRSA nasal swab results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to Charleston Area Medical Center through the Emergency Department with a diagnosis of pneumonia will be evaluated for potential enrollment.
Key inclusion criteria (4 listed)
- Age >= 18 years old
- Patients admitted to Charleston Area Medical Center (CAMC) through the Emergency Department who meet the CDC criteria for pneumonia.
- Nasal surveillance culture for MRSA obtained in the Emergency Department
- Patients receiving vancomycin and additional antibiotic therapy for gram-negative coverage
Key exclusion criteria (11 listed)
- Persistent vasopressor requirements when MRSA nasal swab results are available
- Patients not meeting the CDC criteria for pneumonia
- Patients presenting to the ED with leukopenia (≤4000) without previous documentation of normal or elevated WBC
- Patients receiving empiric MRSA antibiotic therapy other than vancomycin for pneumonia
- Patients with the diagnosis of lung abscess
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Clinical Improvement
Time frame: Evaluation will be completed 48 hours after 7 days of antibiotic therapy for pneumonia.
Rate of clinical improvement following 7 days of antibiotic therapy for pneumonia. Clinical improvement rate is defined as the percentage of patients who had clinical documentation of improvement or resolution of all clinical signs and symptoms of pneumonia present at the time of pneumonia diagnosis. * Afebrile: Temperature <38.0ºC or <100.4ºF * Improvement of respiratory symptoms and signs per clinical documentation: cough, dyspnea, tachypnea, purulent sputum, increase respiratory secretions, increased suctioning requirements * White blood count (WBC) trending down by at least 25%, or when baseline was≤ 15,000 mm3, or return to the normal values * Less oxygen supplementation and ventilation * Chest radiographic improvement per radiologist report (e.g. infiltrate, consolidation or cavitation)
5 secondary outcomes
Hospital Length of Stay
Time frame: During patient hospital stay for up to 6 months
In-hospital mortality
Time frame: During patient hospital stay for up to 6 months
Rate of vancomycin-associated kidney injury defined as a 50% increase in serum creatinine or at least two consecutive increases in serum creatinine by 0.5 mg/dL after at least 48 hours of vancomycin therapy.
Time frame: Time between vancomycin administration and discharge from hospital for up to 6 months.
Hospital complications, such as MRSA bacteremia and septic shock
Time frame: During patient hospital stay for up tp 6 months
Billing cost associated with vancomycin therapy and laboratory monitoring
Time frame: During patient hospital stay for up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Background: PubMed 18992647Edwards JR, Peterson KD, Andrus ML, Dudeck MA, Pollock DA, Horan TC; National Healthcare Safety Network Facilities. National Healthcare Safety Network (NHSN) Report, data summary for 2006 through 2007, issued November 2008. Am J Infect Control. 2008 Nov;36(9):609-26. doi: 10.1016/j.ajic.2008.08.001. No abstract available.
- Background: PubMed 9397368Greenaway CA, Embil J, Orr PH, McLeod J, Dyck B, Nicolle LE. Nosocomial pneumonia on general medical and surgical wards in a tertiary-care hospital. Infect Control Hosp Epidemiol. 1997 Nov;18(11):749-56. doi: 10.1086/647529.
- Background: PubMed 9613899Cook DJ, Kollef MH. Risk factors for ICU-acquired pneumonia. JAMA. 1998 May 27;279(20):1605-6. doi: 10.1001/jama.279.20.1605. No abstract available.
- Background: PubMed 7634921Craven DE, Steger KA. Epidemiology of nosocomial pneumonia. New perspectives on an old disease. Chest. 1995 Aug;108(2 Suppl):1S-16S. doi: 10.1378/chest.108.2_supplement.1s. No abstract available.
- Background: PubMed 23999949Zimlichman E, Henderson D, Tamir O, Franz C, Song P, Yamin CK, Keohane C, Denham CR, Bates DW. Health care-associated infections: a meta-analysis of costs and financial impact on the US health care system. JAMA Intern Med. 2013 Dec 9-23;173(22):2039-46. doi: 10.1001/jamainternmed.2013.9763.
- Background: PubMed 18462093Rubinstein E, Kollef MH, Nathwani D. Pneumonia caused by methicillin-resistant Staphylococcus aureus. Clin Infect Dis. 2008 Jun 1;46 Suppl 5:S378-85. doi: 10.1086/533594.
- Background: PubMed 21208910Liu C, Bayer A, Cosgrove SE, Daum RS, Fridkin SK, Gorwitz RJ, Kaplan SL, Karchmer AW, Levine DP, Murray BE, J Rybak M, Talan DA, Chambers HF; Infectious Diseases Society of America. Clinical practice guidelines by the infectious diseases society of america for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011 Feb 1;52(3):e18-55. doi: 10.1093/cid/ciq146. Epub 2011 Jan 4.
- Background: PubMed 27925784Erb CT, Patel B, Orr JE, Bice T, Richards JB, Metersky ML, Wilson KC, Thomson CC. Management of Adults with Hospital-acquired and Ventilator-associated Pneumonia. Ann Am Thorac Soc. 2016 Dec;13(12):2258-2260. doi: 10.1513/AnnalsATS.201608-641CME. No abstract available.
- Background: PubMed 23165462van Hal SJ, Paterson DL, Lodise TP. Systematic review and meta-analysis of vancomycin-induced nephrotoxicity associated with dosing schedules that maintain troughs between 15 and 20 milligrams per liter. Antimicrob Agents Chemother. 2013 Feb;57(2):734-44. doi: 10.1128/AAC.01568-12. Epub 2012 Nov 19.
- Background: PubMed 19596879Harigaya Y, Bulitta JB, Forrest A, Sakoulas G, Lesse AJ, Mylotte JM, Tsuji BT. Pharmacodynamics of vancomycin at simulated epithelial lining fluid concentrations against methicillin-resistant Staphylococcus aureus (MRSA): implications for dosing in MRSA pneumonia. Antimicrob Agents Chemother. 2009 Sep;53(9):3894-901. doi: 10.1128/AAC.01585-08. Epub 2009 Jul 13.
- Background: PubMed 19106348Rybak M, Lomaestro B, Rotschafer JC, Moellering R Jr, Craig W, Billeter M, Dalovisio JR, Levine DP. Therapeutic monitoring of vancomycin in adult patients: a consensus review of the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2009 Jan 1;66(1):82-98. doi: 10.2146/ajhp080434. No abstract available.
- Background: PubMed 21576448Minejima E, Choi J, Beringer P, Lou M, Tse E, Wong-Beringer A. Applying new diagnostic criteria for acute kidney injury to facilitate early identification of nephrotoxicity in vancomycin-treated patients. Antimicrob Agents Chemother. 2011 Jul;55(7):3278-83. doi: 10.1128/AAC.00173-11. Epub 2011 May 16.
- New CDC study highlights burden of pneumonia hospitalizations among US adults." Centers for Disease Control and Prevention. Accessed January 18, 2017Link provided by the sponsor.
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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.
Audis Bethea, PharmD, BCPS principal investigator
CAMC Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by CAMC 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 11 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: finished, as of the sponsor's last update on 19 Aug 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of Clinical Improvement (time frame: Evaluation will be completed 48 hours after 7 days of antibiotic therapy for pneumonia.). 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 NCT03586362, which also lists 23 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 19 Aug 2026.