PneumoniaNCT02660554
Trial of MRSA Polymerase Chain Reaction for Pneumonia
A study testing Polymerase Chain Reaction (PCR) in people with Pneumonia and Methicillin-Resistant Staphylococcus Aureus, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to conduct a randomized clinical trial to compare an antibiotic strategy based on a novel diagnostic test, polymerase chain reaction (PCR) to usual care, in critically ill adults with pneumonia suspected to be caused by methicillin resistant staphylococcus aureus (MRSA). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pneumonia, Methicillin-Resistant Staphylococcus Aureus
- What is being tested?
- Polymerase Chain Reaction (PCR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 3 May 2019
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older with known or suspected pneumonia who are endotracheally intubated and mechanically ventilated
- Can receive bronchoalveolar lavage (BAL) while intubated
- Have received 24 hours or less of MRSA therapy (the antibiotics vancomycin or linezolid) prior to study enrollment
Who cannot join
- More than 24 hours of MRSA therapy therapy (the antibiotics vancomycin or linezolid),
- Subjects with extra pulmonary infection requiring treatment with vancomycin or linezolid
- Neutropenic fever
- Chronic airway infection
- Patient/surrogate refusal
- Subjects in whom BAL is deemed unsafe by the treating physician
Show all 9Show fewer
- Treating physician refusal to discontinue antibiotics to treat MRSA if PCR negative
- Prisoners
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Rapid Diagnostic Testing to Guide Antibiotic Therapy in Drug Resistant Pneumonia
The purpose of this study is to conduct a randomized clinical trial to compare an antibiotic strategy based on a novel diagnostic test, polymerase chain reaction (PCR) to usual care, in critically ill adults with pneumonia suspected to be caused by methicillin resistant staphylococcus aureus (MRSA). The investigators hypothesize that when automated PCR is used to guide antibiotic therapy, antibiotic exposure will be reduced in critically ill subjects with pneumonia.
Read the detailed description
Bacterial resistance to antibiotics is a major problem in intensive care units (ICUs). The Centers for Disease Control (CDC) estimate drug resistant infections affect more than 2 million individuals nationwide and cause 23,000 deaths annually. In a recent executive order, the President of the United States called for improved antibiotic stewardship and the development of rapid diagnostic tests to identify antibiotic resistant infections. In ICU patients with pneumonia, guidelines advocate the routine use of broad spectrum antibiotics in most patients. In large part this is because diagnostic testing for pneumonia is too insensitive and too slow to inform decision making about appropriate antibiotics. Overuse of broad spectrum antibiotics promotes drug resistance by selecting for antibiotic resistant bacterial strains. This proposal will apply a new diagnostic test, polymerase chain reaction (PCR), to rapidly identify a drug resistant pathogen, methicillin resistant staphylococcus aureus (MRSA) to reduce inappropriate antibiotics in ICU patients with suspected pneumonia.
MRSA is an important cause of drug resistant pneumonia associated with high mortality. Methicillin resistance in Staphylococcus aureus (SA) results from acquisition of the mecA gene located in the mobile element staphylococcal cassette chromosome mec (SCCmec). MRSA pneumonia requires specific antibiotic therapy, treatment guidelines recommend addition of empiric antibiotics against MRSA in patients admitted to the ICU with risk factors for DRPs. The investigators prior work demonstrates that there is significant overlap of MRSA risk factors with risk factors for other DRPs, which potentially leads to the overuse of anti-MRSA antibiotics. Globally, MRSA pneumonia occurs in an estimated 2-6% of ICU patients. By contrast, empiric anti-MRSA therapy is prescribed in the majority of ICU patients with suspected pneumonia. The investigators have shown that at their own institution, the prevalence of MRSA is 5.5%, but empiric anti-MRSA therapy is prescribed in 89.5% of ICU patients with pneumonia. The large gap between empiric antibiotic therapy for MRSA pneumonia and actual cases of MRSA pneumonia is due to the lack of specificity of DRP risk factors, and the time delay of bacterial cultures. Overuse of antibiotics against MRSA has adverse consequences for patients, including new hospital acquired infections (HAIs), increased hospital length of stay (LOS), and higher cost.
Faster and more accurate diagnostic tests for MRSA, such as PCR, have the potential to reduce antibiotic exposure and improve patient outcomes. The time delay of bacterial cultures and the lack of specificity of DRP risk factors is a major limitation to the treatment of pneumonia, particularly in ICUs where the rapid delivery of appropriate antibiotics could be life saving. PCR has the potential to change the paradigm of empiric antibiotics by increasing diagnostic certainty and reducing the time to diagnosis or exclusion of a resistant pathogen. However, molecular diagnostic tests have not yet been validated for routine clinical practice.
The goal of this trial is to compare conduct a clinical trial to compare a PCR guided approach to MRSA therapy to usual care to determine if 1) an antibiotic strategy that utilizes rapid automated PCR reduces antibiotic-days in ICU subject with suspected pneumonia, 2) To compare the safety of an antibiotic strategy that relies on rapid automated PCR to usual care, and 3) To compare costs of the rapid automated PCR based strategy to routine microbiologic cultures.
- Being tested
- Polymerase Chain Reaction (PCR)
- Keywords
- Pneumonia, Methicillin-Resistant Staphylococcus aureus, Polymerase Chain Reaction, Intensive care units, Drug Resistance
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymerase Chain Reaction (PCR)Other
Respiratory samples called bronchoalveolar lavage (BAL) gathered from subjects in the PCR arm will be tested for the presence of MRSA using the Cepheid Xpert® Assay. Xpert® is a qualitative in vitro test designed for rapid detection and differentiation of Staphylococcus aureus (SA) and methicillin resistant Staphylococcus aureus (MRSA) using PCR amplification. MRSA is identified by the mecA gene and staphylococcal cassette chromosome mec (SCCmec). Xpert® Assay is approved by the Federal Drug Administration to detect MRSA in soft tissue samples. Once the PCR is completed, the results will be relayed to the treating physician, and antibiotic therapy (vancomycin or linezolid) will be started or stopped based on the study protocol. All BAL samples will be sent for routine bacterial cultures.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | In the usual care arm, antibiotic therapy against methicillin resistant Staphylococcus aureus (MRSA) will be given at the discretion of the care team. If bacterial cultures are negative for MRSA at 72 hours, the treating physician will be prompted to discontinue MRSA therapy. |
| Polymerase Chain Reaction | Experimental | In subjects randomized to the polymerase chain reaction (PCR) arm, antibiotic therapy against methicillin resistant Staphylococcus aureus (MRSA) will be determined by the results of the PCR test. In subjects who are clinically stable, results from the PCR must be available prior to the administration of MRSA therapy. Subjects with a positive MRSA PCR will be administered MRSA therapy. In subjects with a negative MRSA PCR, MRSA therapy will be withheld. In subjects randomized to the automated PCR arm who are clinically unstable, empiric MRSA therapy will be allowed until the PCR is completed. In these cases of unstable subjects, empiric MRSA therapy will be discontinued if the PCR is negative. Receives: Other: Polymerase Chain Reaction (PCR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of anti-MRSA antibiotic therapy
days for initially suspected MRSA pneumonia
Measured: 14 days
Secondary outcomes (4)
Mortality
All cause mortality
Measured: 28 days post randomization
Organ dysfunction
Days alive and organ dysfunction free for 28 days (based on daily SOFA score)
Measured: 28 days post randomization
Renal Organ dysfunction
Days alive and renal organ dysfunction free for 28 days (based on daily SOFA renal organ score)
Measured: 28 days post randomization
Days of subsequent anti-MRSA treatment
total days of vancomycin or linezolid treatment
Measured: 28 days post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startJan 2016
- Primary completion28 Feb 2017
- Study completion3 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Wunderink, Northwestern University
- Investigators
- Richard G Wunderink, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660554
- Sponsor's protocol ID
- STU00202148
- Status last verified
- Feb 2023
- First submitted
- 4 Jan 2016
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wunderink RG. How important is methicillin-resistant Staphylococcus aureus as a cause of community-acquired pneumonia and what is best antimicrobial therapy? Infect Dis Clin North Am. 2013 Mar;27(1):177-88. doi: 10.1016/j.idc.2012.11.006. Epub 2012 Dec 14.
PubMed 23398873Shindo Y, Ito R, Kobayashi D, Ando M, Ichikawa M, Shiraki A, Goto Y, Fukui Y, Iwaki M, Okumura J, Yamaguchi I, Yagi T, Tanikawa Y, Sugino Y, Shindoh J, Ogasawara T, Nomura F, Saka H, Yamamoto M, Taniguchi H, Suzuki R, Saito H, Kawamura T, Hasegawa Y. Risk factors for drug-resistant pathogens in community-acquired and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2013 Oct 15;188(8):985-95. doi: 10.1164/rccm.201301-0079OC.
PubMed 23855620Kollef MH, Micek ST. Strategies to prevent antimicrobial resistance in the intensive care unit. Crit Care Med. 2005 Aug;33(8):1845-53. doi: 10.1097/01.ccm.0000171849.04952.79.
PubMed 16096464American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
PubMed 15699079Mandell LA, Wunderink RG, Anzueto A, Bartlett JG, Campbell GD, Dean NC, Dowell SF, File TM Jr, Musher DM, Niederman MS, Torres A, Whitney CG; Infectious Diseases Society of America; American Thoracic Society. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007 Mar 1;44 Suppl 2(Suppl 2):S27-72. doi: 10.1086/511159. No abstract available.
PubMed 17278083Haley CC, Mittal D, Laviolette A, Jannapureddy S, Parvez N, Haley RW. Methicillin-resistant Staphylococcus aureus infection or colonization present at hospital admission: multivariable risk factor screening to increase efficiency of surveillance culturing. J Clin Microbiol. 2007 Sep;45(9):3031-8. doi: 10.1128/JCM.00315-07. Epub 2007 Jul 11.
PubMed 17626171Rimawi RH, Mazer MA, Siraj DS, Gooch M, Cook PP. Impact of regular collaboration between infectious diseases and critical care practitioners on antimicrobial utilization and patient outcome. Crit Care Med. 2013 Sep;41(9):2099-107. doi: 10.1097/CCM.0b013e31828e9863.
PubMed 23873275Raman K, Nailor MD, Nicolau DP, Aslanzadeh J, Nadeau M, Kuti JL. Early antibiotic discontinuation in patients with clinically suspected ventilator-associated pneumonia and negative quantitative bronchoscopy cultures. Crit Care Med. 2013 Jul;41(7):1656-63. doi: 10.1097/CCM.0b013e318287f713.
PubMed 23528805Goff DA, Jankowski C, Tenover FC. Using rapid diagnostic tests to optimize antimicrobial selection in antimicrobial stewardship programs. Pharmacotherapy. 2012 Aug;32(8):677-87. doi: 10.1002/j.1875-9114.2012.01137.x.
PubMed 23307517Cercenado E, Marin M, Burillo A, Martin-Rabadan P, Rivera M, Bouza E. Rapid detection of Staphylococcus aureus in lower respiratory tract secretions from patients with suspected ventilator-associated pneumonia: evaluation of the Cepheid Xpert MRSA/SA SSTI assay. J Clin Microbiol. 2012 Dec;50(12):4095-7. doi: 10.1128/JCM.02409-12. Epub 2012 Sep 19.
PubMed 22993185Oh AC, Lee JK, Lee HN, Hong YJ, Chang YH, Hong SI, Kim DH. Clinical utility of the Xpert MRSA assay for early detection of methicillin-resistant Staphylococcus aureus. Mol Med Rep. 2013 Jan;7(1):11-5. doi: 10.3892/mmr.2012.1121. Epub 2012 Oct 9.
PubMed 23064681Leone M, Malavieille F, Papazian L, Meyssignac B, Cassir N, Textoris J, Antonini F, La Scola B, Martin C, Allaouchiche B, Hraiech S; AzuRea Network. Routine use of Staphylococcus aureus rapid diagnostic test in patients with suspected ventilator-associated pneumonia. Crit Care. 2013 Aug 6;17(4):R170. doi: 10.1186/cc12849.
PubMed 23919575Salgado CD, Farr BM, Calfee DP. Community-acquired methicillin-resistant Staphylococcus aureus: a meta-analysis of prevalence and risk factors. Clin Infect Dis. 2003 Jan 15;36(2):131-9. doi: 10.1086/345436. Epub 2003 Jan 3.
PubMed 12522744Paonessa JR, Shah RD, Pickens CI, Lizza BD, Donnelly HK, Malczynski M, Qi C, Wunderink RG. Rapid Detection of Methicillin-Resistant Staphylococcus aureus in BAL: A Pilot Randomized Controlled Trial. Chest. 2019 May;155(5):999-1007. doi: 10.1016/j.chest.2019.02.007. Epub 2019 Feb 15.
PubMed 30776365
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Diagnostic Testing to Guide Antibiotic Therapy in Drug Resistant Pneumonia
- ClinicalTrials.gov ID
- NCT02660554
- Acronym / sponsor ID
- STU00202148
- Keywords
- Pneumonia, Methicillin-Resistant Staphylococcus aureus, Polymerase Chain Reaction, Intensive care units, Drug Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 3 May 2019 (actual)
- First posted
- 21 Jan 2016 (estimated)
- 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.
The purpose of this study is to conduct a randomized clinical trial to compare an antibiotic strategy based on a novel diagnostic test, polymerase chain reaction (PCR) to usual care, in critically ill adults with pneumonia suspected to be caused by methicillin resistant staphylococcus aureus (MRSA). The investigators hypothesize that when automated PCR is used to guide antibiotic therapy, antibiotic exposure will be reduced in critically ill subjects with pneumonia.
Detailed description
Bacterial resistance to antibiotics is a major problem in intensive care units (ICUs). The Centers for Disease Control (CDC) estimate drug resistant infections affect more than 2 million individuals nationwide and cause 23,000 deaths annually. In a recent executive order, the President of the United States called for improved antibiotic stewardship and the development of rapid diagnostic tests to identify antibiotic resistant infections. In ICU patients with pneumonia, guidelines advocate the routine use of broad spectrum antibiotics in most patients. In large part this is because diagnostic testing for pneumonia is too insensitive and too slow to inform decision making about appropriate antibiotics. Overuse of broad spectrum antibiotics promotes drug resistance by selecting for antibiotic resistant bacterial strains. This proposal will apply a new diagnostic test, polymerase chain reaction (PCR), to rapidly identify a drug resistant pathogen, methicillin resistant staphylococcus aureus (MRSA) to reduce inappropriate antibiotics in ICU patients with suspected pneumonia.
MRSA is an important cause of drug resistant pneumonia associated with high mortality. Methicillin resistance in Staphylococcus aureus (SA) results from acquisition of the mecA gene located in the mobile element staphylococcal cassette chromosome mec (SCCmec). MRSA pneumonia requires specific antibiotic therapy, treatment guidelines recommend addition of empiric antibiotics against MRSA in patients admitted to the ICU with risk factors for DRPs. The investigators prior work demonstrates that there is significant overlap of MRSA risk factors with risk factors for other DRPs, which potentially leads to the overuse of anti-MRSA antibiotics. Globally, MRSA pneumonia occurs in an estimated 2-6% of ICU patients. By contrast, empiric anti-MRSA therapy is prescribed in the majority of ICU patients with suspected pneumonia. The investigators have shown that at their own institution, the prevalence of MRSA is 5.5%, but empiric anti-MRSA therapy is prescribed in 89.5% of ICU patients with pneumonia. The large gap between empiric antibiotic therapy for MRSA pneumonia and actual cases of MRSA pneumonia is due to the lack of specificity of DRP risk factors, and the time delay of bacterial cultures. Overuse of antibiotics against MRSA has adverse consequences for patients, including new hospital acquired infections (HAIs), increased hospital length of stay (LOS), and higher cost.
Faster and more accurate diagnostic tests for MRSA, such as PCR, have the potential to reduce antibiotic exposure and improve patient outcomes. The time delay of bacterial cultures and the lack of specificity of DRP risk factors is a major limitation to the treatment of pneumonia, particularly in ICUs where the rapid delivery of appropriate antibiotics could be life saving. PCR has the potential to change the paradigm of empiric antibiotics by increasing diagnostic certainty and reducing the time to diagnosis or exclusion of a resistant pathogen. However, molecular diagnostic tests have not yet been validated for routine clinical practice.
The goal of this trial is to compare conduct a clinical trial to compare a PCR guided approach to MRSA therapy to usual care to determine if 1) an antibiotic strategy that utilizes rapid automated PCR reduces antibiotic-days in ICU subject with suspected pneumonia, 2) To compare the safety of an antibiotic strategy that relies on rapid automated PCR to usual care, and 3) To compare costs of the rapid automated PCR based strategy to routine microbiologic cultures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –In the usual care arm, antibiotic therapy against methicillin resistant Staphylococcus aureus (MRSA) will be given at the discretion of the care team. If bacterial cultures are negative for MRSA at 72 hours, the treating physician will be prompted to discontinue MRSA therapy. |
| Polymerase Chain Reaction | Experimental | Other: Polymerase Chain Reaction (PCR)In subjects randomized to the polymerase chain reaction (PCR) arm, antibiotic therapy against methicillin resistant Staphylococcus aureus (MRSA) will be determined by the results of the PCR test. In subjects who are clinically stable, results from the PCR must be available prior to the administration of MRSA therapy. Subjects with a positive MRSA PCR will be administered MRSA therapy. In subjects with a negative MRSA PCR, MRSA therapy will be withheld. In subjects randomized to the automated PCR arm who are clinically unstable, empiric MRSA therapy will be allowed until the PCR is completed. In these cases of unstable subjects, empiric MRSA therapy will be discontinued if the PCR is negative. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years and older with known or suspected pneumonia who are endotracheally intubated and mechanically ventilated
- Can receive bronchoalveolar lavage (BAL) while intubated
- Have received 24 hours or less of MRSA therapy (the antibiotics vancomycin or linezolid) prior to study enrollment
Key exclusion criteria (9 listed)
- More than 24 hours of MRSA therapy therapy (the antibiotics vancomycin or linezolid),
- Subjects with extra pulmonary infection requiring treatment with vancomycin or linezolid
- Neutropenic fever
- Chronic airway infection
- Patient/surrogate refusal
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 |
|---|---|---|
| Polymerase Chain Reaction (PCR)Respiratory samples called bronchoalveolar lavage (BAL) gathered from subjects in the PCR arm will be tested for the presence of MRSA using the Cepheid Xpert® Assay. Xpert® is a qualitative in vitro test designed for rapid detection and differentiation of Staphylococcus aureus (SA) and methicillin resistant Staphylococcus aureus (MRSA) using PCR amplification. MRSA is identified by the mecA gene and staphylococcal cassette chromosome mec (SCCmec). Xpert® Assay is approved by the Federal Drug Administration to detect MRSA in soft tissue samples. Once the PCR is completed, the results will be relayed to the treating physician, and antibiotic therapy (vancomycin or linezolid) will be started or stopped based on the study protocol. All BAL samples will be sent for routine bacterial cultures. | Other | Polymerase Chain Reaction |
Primary outcome
Days of anti-MRSA antibiotic therapy
Time frame: 14 days
days for initially suspected MRSA pneumonia
4 secondary outcomes
Mortality
Time frame: 28 days post randomization
Organ dysfunction
Time frame: 28 days post randomization
Renal Organ dysfunction
Time frame: 28 days post randomization
Days of subsequent anti-MRSA treatment
Time frame: 28 days post randomization
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 10 Feb 2023.
- Background: PubMed 23398873Wunderink RG. How important is methicillin-resistant Staphylococcus aureus as a cause of community-acquired pneumonia and what is best antimicrobial therapy? Infect Dis Clin North Am. 2013 Mar;27(1):177-88. doi: 10.1016/j.idc.2012.11.006. Epub 2012 Dec 14.
- Background: PubMed 23855620Shindo Y, Ito R, Kobayashi D, Ando M, Ichikawa M, Shiraki A, Goto Y, Fukui Y, Iwaki M, Okumura J, Yamaguchi I, Yagi T, Tanikawa Y, Sugino Y, Shindoh J, Ogasawara T, Nomura F, Saka H, Yamamoto M, Taniguchi H, Suzuki R, Saito H, Kawamura T, Hasegawa Y. Risk factors for drug-resistant pathogens in community-acquired and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2013 Oct 15;188(8):985-95. doi: 10.1164/rccm.201301-0079OC.
- Background: PubMed 16096464Kollef MH, Micek ST. Strategies to prevent antimicrobial resistance in the intensive care unit. Crit Care Med. 2005 Aug;33(8):1845-53. doi: 10.1097/01.ccm.0000171849.04952.79.
- Background: PubMed 15699079American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
- Background: PubMed 17278083Mandell LA, Wunderink RG, Anzueto A, Bartlett JG, Campbell GD, Dean NC, Dowell SF, File TM Jr, Musher DM, Niederman MS, Torres A, Whitney CG; Infectious Diseases Society of America; American Thoracic Society. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007 Mar 1;44 Suppl 2(Suppl 2):S27-72. doi: 10.1086/511159. No abstract available.
- Background: PubMed 17626171Haley CC, Mittal D, Laviolette A, Jannapureddy S, Parvez N, Haley RW. Methicillin-resistant Staphylococcus aureus infection or colonization present at hospital admission: multivariable risk factor screening to increase efficiency of surveillance culturing. J Clin Microbiol. 2007 Sep;45(9):3031-8. doi: 10.1128/JCM.00315-07. Epub 2007 Jul 11.
- Background: PubMed 23873275Rimawi RH, Mazer MA, Siraj DS, Gooch M, Cook PP. Impact of regular collaboration between infectious diseases and critical care practitioners on antimicrobial utilization and patient outcome. Crit Care Med. 2013 Sep;41(9):2099-107. doi: 10.1097/CCM.0b013e31828e9863.
- Background: PubMed 23528805Raman K, Nailor MD, Nicolau DP, Aslanzadeh J, Nadeau M, Kuti JL. Early antibiotic discontinuation in patients with clinically suspected ventilator-associated pneumonia and negative quantitative bronchoscopy cultures. Crit Care Med. 2013 Jul;41(7):1656-63. doi: 10.1097/CCM.0b013e318287f713.
- Background: PubMed 23307517Goff DA, Jankowski C, Tenover FC. Using rapid diagnostic tests to optimize antimicrobial selection in antimicrobial stewardship programs. Pharmacotherapy. 2012 Aug;32(8):677-87. doi: 10.1002/j.1875-9114.2012.01137.x.
- Background: PubMed 22993185Cercenado E, Marin M, Burillo A, Martin-Rabadan P, Rivera M, Bouza E. Rapid detection of Staphylococcus aureus in lower respiratory tract secretions from patients with suspected ventilator-associated pneumonia: evaluation of the Cepheid Xpert MRSA/SA SSTI assay. J Clin Microbiol. 2012 Dec;50(12):4095-7. doi: 10.1128/JCM.02409-12. Epub 2012 Sep 19.
- Background: PubMed 23064681Oh AC, Lee JK, Lee HN, Hong YJ, Chang YH, Hong SI, Kim DH. Clinical utility of the Xpert MRSA assay for early detection of methicillin-resistant Staphylococcus aureus. Mol Med Rep. 2013 Jan;7(1):11-5. doi: 10.3892/mmr.2012.1121. Epub 2012 Oct 9.
- Background: PubMed 23919575Leone M, Malavieille F, Papazian L, Meyssignac B, Cassir N, Textoris J, Antonini F, La Scola B, Martin C, Allaouchiche B, Hraiech S; AzuRea Network. Routine use of Staphylococcus aureus rapid diagnostic test in patients with suspected ventilator-associated pneumonia. Crit Care. 2013 Aug 6;17(4):R170. doi: 10.1186/cc12849.
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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.
Richard G Wunderink, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polymerase Chain Reaction (PCR) in people with Pneumonia and Methicillin-Resistant Staphylococcus Aureus, run by Northwestern University 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 3 inclusion and 9 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 10 Feb 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.
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?
Days of anti-MRSA antibiotic therapy (time frame: 14 days). 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 NCT02660554, which also lists 14 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 10 Feb 2023.