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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
  • 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

    Recruiting

Other trials in Egypt

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

  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 isn't a frequent contaminant.
  4. Bacterial isolates from blood will be analysed by utilizing an automatic blood culture system (Bact/Alert).
  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 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 groups in NCT06458231
Study groupRoleWhat they receive
No of Positive CLABSINo of +ve CLABSI in different types of cases,
Receives: Device: Blood Catheters
Primary Blood stream infectionParticipant with blood stream infection not related to other other infection in the body
Receives: Device: Blood Catheters
Secondary Blood stream infectionBlood 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.

  1. • Microbiological diagnosis and Culture sensitivity tests

    • Microbiological diagnosis and Culture sensitivity tests by automated Bact Alert and Vitek2c systems for CLABSI.

    Measured: 6 months

  2. Determine antibiotic biogram of each organism isolated

    Determine antibiotic biogram of each organism isolated

    Measured: 6 months

Secondary outcomes (1)
  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.

  1. First posted13 Jun 2024
  2. Study start25 Jun 2024 (estimated)
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion31 May 2025 (estimated)

Resources

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)
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

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.

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