Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458231
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-09
Brief Title:
Determining the Prevalence of Primary and Secondary Central Line Associated Blood Stream Infection CLABSI at the Tertiary Care Hospital
Sponsor:
Port Said University
Organization:
Port Said University
Study Overview
Official Title:
Determining the Prevalence of Primary and Secondary Central Line Associated Blood Stream Infection CLABSI at the Tertiary Care Hospital
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Microbiology
Brief Summary:
Review key history and clinical examination findings of cases with CLABSI
Microbiological diagnosis and Culture sensitivity tests by automated Bact Alert and Vitek2c systems for CLABSI
Determine antibiotic biogram of each organism isolated
Determine the prevalence of occurrence of Primary or secondary Blood stream infection causing microorganism and predisposing factors
Microbiological diagnosis and Culture sensitivity tests by automated Bact Alert and Vitek2c systems for CLABSI
Determine antibiotic biogram of each organism isolated
Determine the prevalence of occurrence of Primary or secondary Blood stream infection causing microorganism and predisposing factors
Detailed Description:
Subjects and Methods
Study Design
This cross-sectional descriptive study will be conducted on admitted patients in Cardiovascular Unit at the Tertiary Care Hospital in Port Said hospitals
Subjects
From each patient the following data will be collected full medical history symptoms and signs lab investigations including serum electrolytes procalcitonin liver and kidney function tests receipt of antibiotics and its response
Inclusion criteria
Patients diagnosed with sepsis based on medical history lab investigations and clinical picture
Both sex and all age-groups
Exclusion criteria
Patients diagnosed with sepsis proved by medical history lab investigations and clinical picture who received non-beta lactam antibiotics for the past 24 hours
Samples proved contaminated by microbial flora will be rejected
Methods
Study design This study will be conducted at the tertiary care hospital which offers a medical and surgery ICU and also has a cardiovascular Unit
Epidemiologic and clinical information of patients and classification of the bacteremia as Primary Bloodstream Infections PBI and Secondary Bloodstream Infections SBI based on CDC criteria 5 and its National Healthcare Safety Network NHSN yearly update
Sample collection
1 Venous blood samples from cases with suspected sepsis or bacteremia will be incubated with a medium which encourages promotes bacterial growth
2 We will take samples of 2 or more sets of aerobic and anaerobic blood cultures 3or 8 mL per small or large bottle
3 Two blood cultures drawn from different areas are frequently enough to diagnose bacteremia Two out of 2 cultures growing identical type of bacteria often represents a real bacteremia in particular if the organism which grows isnt a frequent contaminant
4 Bacterial isolates from blood will be analysed by utilizing an automatic blood culture system BactAlert
5 Positive samples will be cultured on different selective media Primary organism recognition will be done with matrix assisted laser desorption ionization time of flight MS on a Vitek MS system BioMerieux Inc France
6 Calibration will be performed using standard strains to validate the run
7 Minimum Inhibitory Concentration MIC outcomes will be interpreted based on the Clinical and Laboratory Standards Institute CLSI protocols
8 Biochemical tests which include CRP of Procalcitonin is most of time increased among cases with BSI
Sample size
Number of Samples is calculated according to the next equation
N Z α2²P1-Pd² Daniel 2009 In which N the required sample size Z α2 A normal deviation reflect the type 1 error 196 P the prevalence of atypical bacteria in sputum samples 46 13 D the accuracy of estimate how close to the true population 01
Thus N 60 blood samples
Data Management and Statistical Analysis The results of the collected data will entered into SPSS-19 program for statistical analysis
Descriptive data will be managed based on its type mean SD and range will summarize continuous data While qualitative data will be summarized by frequencies
With regard to analytic data chi square test will be utilized to determine the difference between qualitative data while T test and ANOVA will be utilized to determine the difference between quantitative data
Ethical considerations
The samples will be collected from patients after taking written informed consent
The study will be conducted after taking the permission from chairman of each department
The results of the patient will be confidential
The patient will be informed of the results and will be treated accordingly
The patient has the right to leave the study without compromising the patients treatment or the patients relationship with the care provider
Study Design
This cross-sectional descriptive study will be conducted on admitted patients in Cardiovascular Unit at the Tertiary Care Hospital in Port Said hospitals
Subjects
From each patient the following data will be collected full medical history symptoms and signs lab investigations including serum electrolytes procalcitonin liver and kidney function tests receipt of antibiotics and its response
Inclusion criteria
Patients diagnosed with sepsis based on medical history lab investigations and clinical picture
Both sex and all age-groups
Exclusion criteria
Patients diagnosed with sepsis proved by medical history lab investigations and clinical picture who received non-beta lactam antibiotics for the past 24 hours
Samples proved contaminated by microbial flora will be rejected
Methods
Study design This study will be conducted at the tertiary care hospital which offers a medical and surgery ICU and also has a cardiovascular Unit
Epidemiologic and clinical information of patients and classification of the bacteremia as Primary Bloodstream Infections PBI and Secondary Bloodstream Infections SBI based on CDC criteria 5 and its National Healthcare Safety Network NHSN yearly update
Sample collection
1 Venous blood samples from cases with suspected sepsis or bacteremia will be incubated with a medium which encourages promotes bacterial growth
2 We will take samples of 2 or more sets of aerobic and anaerobic blood cultures 3or 8 mL per small or large bottle
3 Two blood cultures drawn from different areas are frequently enough to diagnose bacteremia Two out of 2 cultures growing identical type of bacteria often represents a real bacteremia in particular if the organism which grows isnt a frequent contaminant
4 Bacterial isolates from blood will be analysed by utilizing an automatic blood culture system BactAlert
5 Positive samples will be cultured on different selective media Primary organism recognition will be done with matrix assisted laser desorption ionization time of flight MS on a Vitek MS system BioMerieux Inc France
6 Calibration will be performed using standard strains to validate the run
7 Minimum Inhibitory Concentration MIC outcomes will be interpreted based on the Clinical and Laboratory Standards Institute CLSI protocols
8 Biochemical tests which include CRP of Procalcitonin is most of time increased among cases with BSI
Sample size
Number of Samples is calculated according to the next equation
N Z α2²P1-Pd² Daniel 2009 In which N the required sample size Z α2 A normal deviation reflect the type 1 error 196 P the prevalence of atypical bacteria in sputum samples 46 13 D the accuracy of estimate how close to the true population 01
Thus N 60 blood samples
Data Management and Statistical Analysis The results of the collected data will entered into SPSS-19 program for statistical analysis
Descriptive data will be managed based on its type mean SD and range will summarize continuous data While qualitative data will be summarized by frequencies
With regard to analytic data chi square test will be utilized to determine the difference between qualitative data while T test and ANOVA will be utilized to determine the difference between quantitative data
Ethical considerations
The samples will be collected from patients after taking written informed consent
The study will be conducted after taking the permission from chairman of each department
The results of the patient will be confidential
The patient will be informed of the results and will be treated accordingly
The patient has the right to leave the study without compromising the patients treatment or the patients relationship with the care provider
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None