Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01198262
Other study ID # H-23059
Secondary ID
Status Completed
Phase N/A
First received September 9, 2010
Last updated September 9, 2010
Start date April 2008
Est. completion date August 2010

Study information

Verified date October 2008
Source VA Medical Center, Houston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine whether the Cepheid GeneXpert system accurately detects Methicillin-Resistant and -Susceptible Staphylococcus aureus in blood cultures and wound swabs.


Description:

Staphylococcus aureus (SA) remains a major pathogen for human beings, causing infections of skin, soft tissue, bone, and other organs. Bacteremia due to this organism is common, and often occurs in association with medical interventions such as intravenous lines and implantable devices. With the increase in methicillin-resistant S. aureus (MRSA), there has been increasing dependence upon vancomycin, a drug that is inferior to the beta-lactams in its activity against methicillin-susceptible S. aureus (MSSA). If the microbiology laboratory had the ability to identify S. aureus (SA) and its drug susceptibility within hours rather than days, focused therapy would be possible earlier in the course of illness. Clinicians would be able to discontinue antibiotics when SA is not present, to discontinue other broad-spectrum antibiotics when SA is present, or to replace empiric vancomycin with nafcillin when MSSA is identified.

The GeneXpert system (Cepheid) uses real-time PCR to detect genes that encode Staphylococcus aureus protein A (SPA), the staphylococcal cassette chromosome (SCC) and methicillin resistance (mecA). All blood cultures with Gram stain revealing Gram positive cocci in clusters will be tested by PCR the day they became positive. Wound swabs submitted for routine bacteriologic culture will be tested within 48 hr of collection. Results will be compared with those of standard bacteriologic culture. In addition, discrepancies between the GeneXpert and wound culture results will be reviewed in the medical record to ascertain whether antibiotic use at the time of specimen collection is associated with false positive results in which the wound culture yields no S. aureus but PCR detects staphylococcal DNA components.

In the second phase of the study, PCR results for wound swabs and blood cultures will be reported to physicians immediately upon completion of the reaction. The clinical impact of early identification of S. aureus will be determined by comparing antibiotic treatment and clinical outcome of patients for whom early identification was available with those of patients for whom conventional bacteriological culture was the sole diagnostic test.


Recruitment information / eligibility

Status Completed
Enrollment 260
Est. completion date August 2010
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Positive blood culture with Gram stain revealing Gram positive cocci in clusters

- All wound swabs submitted to the microbiology lab for standard bacteriologic culture may be included.

Exclusion Criteria:

- Blood cultures that became positive more than 24 hours previously

- Wound swabs for which over 48 hours have passed from the time of collection

Study Design

Time Perspective: Retrospective


Locations

Country Name City State
United States Michael E. DeBakey VA Medical Center Houston Texas

Sponsors (3)

Lead Sponsor Collaborator
VA Medical Center, Houston Baylor College of Medicine, Cepheid

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary concordance between PCR results and those of standard bacteriologic culture 1 year No
Secondary Impact of early identification of S. aureus on the antibiotics prescribed by physicians and subsequent clinical outcome. 1 year No
See also
  Status Clinical Trial Phase
Completed NCT03894046 - Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex Phase 3
Active, not recruiting NCT03354338 - Amoxicillin to Prevent Bacteria and Inflammatory Biomarkers After Intensive Periodontal Therapy Phase 2
Withdrawn NCT02543957 - Factors Associated With Increased Risk of Bacteremia and Cholangitis in ERCP With Cholangioscopy
Completed NCT02210169 - RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates N/A
Completed NCT01410578 - The Value of sTREM-1, PCT, and CRP as Markers for the Detection of Sepsis and Bacteremia Among Patients With a FUO N/A
Terminated NCT00428051 - Colombia Epidemiologic Surveillance Study N/A
Completed NCT00609375 - Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen Phase 4
Terminated NCT00108433 - Linezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections Phase 3
Completed NCT00177736 - Pharmacodynamic Parameters of Two Different Doses of Cefepime Phase 4
Completed NCT00571259 - Prophylactic Antimicrobial Catheter Lock Phase 4
Completed NCT00027248 - Safety and Efficacy of MBI 226 for the Prevention of Central Venous Catheter-Related Bloodstream Infections Phase 3
Completed NCT05585463 - Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)
Recruiting NCT05950984 - Medical Device (MD) Derived Pharmacokinetic (PK) Parameters for Vancomycin (MD-PK)
Completed NCT03148769 - Spanish Bacteriemia Cohort 2016: Epidemiology, Clinical Management and Prognosis Factors
Completed NCT02536352 - Effect of Supplementation of Fluoride on Maternal Periodontal Health, Preterm Delivery, and Perinatal Well-Being Early Phase 1
Completed NCT02869191 - Blood Cultures's Profitability in Intensive Care Unit
Terminated NCT01734694 - Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients Phase 4
Completed NCT01179022 - Incidence of Bacteremia Following Argon Plasma Coagulation in Patients With Endobronchial Lesions N/A
Recruiting NCT00404625 - Infections Caused by ESbL-Producing Enterobacteriaceae in Italy N/A
Completed NCT00398411 - Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells Phase 3