Central Line-associated Bloodstream Infection (CLABSI)MicrobiologyNCT06458231
Determining the Prevalence of Primary and Secondary Central Line Associated Blood Stream Infection (CLABSI) at the Tertiary Care Hospital
An observational study of Central Line-associated Bloodstream Infection (CLABSI), run by Port Said University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Central Line-associated Bloodstream Infection (CLABSI)
- What is being tested?
- Blood Catheters
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 2 sitesEgypt
- Study dates
- 25 Jun 2024to 31 May 2025
- 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 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Venous blood samples from cases with suspected sepsis, or bacteremia will be incubated with a medium which encourages promotes bacterial growth.
Who may be able to join
- • Patients diagnosed with sepsis based on medical history, lab investigations and clinical picture.
- Both sex, and all age-groups.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Prof. Refat Sadeq
Port Said, 22223
Refat A. Sadeq, Ph D, 01003737012, refat.sadek@med.psu.edu.eg
- Recruiting
Faculty of Medicine Portsaid Uni
Port Said
Refat Sadeq, 00201003737012, refat.sadek@med.psu.edu.eg
Marwa Halawa, MBBCH
About this study
- 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.
Read the 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
- Venous blood samples from cases with suspected sepsis, or bacteremia will be incubated with a medium which encourages promotes bacterial growth.
- We will take samples of 2 or more sets of aerobic and anaerobic blood cultures (3or 8 mL per small or large bottle)
- 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 isn't a frequent contaminant.
- Bacterial isolates from blood will be analysed by utilizing an automatic blood culture system (Bact/Alert).
- 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).
- Calibration will be performed using standard strains to validate the run.
- Minimum Inhibitory Concentration (MIC) outcomes will be interpreted based on the Clinical and Laboratory Standards Institute (CLSI) protocols.
- 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 α\2)²×P(1-P)\d² (Daniel, 2009) In which; N= the required sample size (Z α\2) = A normal deviation reflect the type 1 error = 1.96 P = the prevalence of atypical bacteria in sputum samples = (46%) (13). D = the accuracy of estimate (how close to the true population) = 0.1
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 patient's treatment or the patient's relationship with the care provider.
- Being tested
- Blood Catheters
- Keywords
- CLABSI, Primary B.I., Secondary B.I.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood CathetersDevice
Central line as a predisposing factor for Blood stream infection
| Study group | Role | What they receive |
|---|---|---|
| No of Positive CLABSI | No of +ve CLABSI in different types of cases, Receives: Device: Blood Catheters | |
| Primary Blood stream infection | Participant with blood stream infection not related to other other infection in the body Receives: Device: Blood Catheters | |
| Secondary Blood stream infection | Blood stream infection occur as a complication to infection in other parts of the body Receives: Device: Blood Catheters | |
| Blood Prevalence of types microorg. | % and Prevalence of different microorg causing Blood stream infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Microbiological diagnosis and Culture sensitivity tests
- Microbiological diagnosis and Culture sensitivity tests by automated Bact Alert and Vitek2c systems for CLABSI.
Measured: 6 months
Determine antibiotic biogram of each organism isolated
Determine antibiotic biogram of each organism isolated
Measured: 6 months
Secondary outcomes (1)
•Determine the prevalence of occurrence of Primary or secondary Blood stream infection
•Determine the prevalence of occurrence of Primary or secondary Blood stream infection, causing microorganism, and predisposing factors.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start25 Jun 2024 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Line-associated Bloodstream Infection (CLABSI)Studies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Port Said University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458231
- Sponsor's protocol ID
- Micro
- Acronym
- Microbiology
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication in Medical journals
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Prevalence of Primary and Secondary Central Line Associated Blood Stream Infection (CLABSI) at the Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT06458231
- Acronym / sponsor ID
- Microbiology / Micro
- Keywords
- CLABSI, Primary B.I., Secondary B.I.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Port Said UniversityUniversity, hospital or other
- Study start
- 25 Jun 2024 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 13 Jun 2024 (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.
- 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.
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
- Venous blood samples from cases with suspected sepsis, or bacteremia will be incubated with a medium which encourages promotes bacterial growth.
- We will take samples of 2 or more sets of aerobic and anaerobic blood cultures (3or 8 mL per small or large bottle)
- 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 isn't a frequent contaminant.
- Bacterial isolates from blood will be analysed by utilizing an automatic blood culture system (Bact/Alert).
- 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).
- Calibration will be performed using standard strains to validate the run.
- Minimum Inhibitory Concentration (MIC) outcomes will be interpreted based on the Clinical and Laboratory Standards Institute (CLSI) protocols.
- 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 α\2)²×P(1-P)\d² (Daniel, 2009) In which; N= the required sample size (Z α\2) = A normal deviation reflect the type 1 error = 1.96 P = the prevalence of atypical bacteria in sputum samples = (46%) (13). D = the accuracy of estimate (how close to the true population) = 0.1
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 patient's treatment or the patient's relationship with the care provider.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No of Positive CLABSI | – | Device: Blood CathetersNo of +ve CLABSI in different types of cases, |
| Primary Blood stream infection | – | Device: Blood CathetersParticipant with blood stream infection not related to other other infection in the body |
| Secondary Blood stream infection | – | Device: Blood CathetersBlood stream infection occur as a complication to infection in other parts of the body |
| Blood Prevalence of types microorg. | – | –% and Prevalence of different microorg causing Blood stream infection |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Venous blood samples from cases with suspected sepsis, or bacteremia will be incubated with a medium which encourages promotes bacterial growth.
Key inclusion criteria (2 listed)
- • Patients diagnosed with sepsis based on medical history, lab investigations and clinical picture.
Key exclusion criteria (2 listed)
- Patients diagnosed with sepsis proved by medical history, lab investigations and clinical picture who received non-beta lactam antibiotics for the past 24 hours.
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 |
|---|---|---|
| Blood CathetersCentral line as a predisposing factor for Blood stream infection | Device | No of Positive CLABSI, Primary Blood stream infection, Secondary Blood stream infection |
Primary outcome
• Microbiological diagnosis and Culture sensitivity tests
Time frame: 6 months
• Microbiological diagnosis and Culture sensitivity tests by automated Bact Alert and Vitek2c systems for CLABSI.
Determine antibiotic biogram of each organism isolated
Time frame: 6 months
Determine antibiotic biogram of each organism isolated
1 secondary outcome
•Determine the prevalence of occurrence of Primary or secondary Blood stream infection
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: Yes. Publication in Medical journals
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Line-associated Bloodstream Infection (CLABSI), run by Port Said University at 2 sites in Egypt.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Microbiological diagnosis and Culture sensitivity tests (time frame: 6 months). The study lists 2 primary outcomes in all. 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 13 Jun 2024.