SepsisNCT05507957
Impact of Blood Culture Positivity Time on Clinical Management of Pediatric ICU Patients
An observational study of Sepsis, run by Assiut University at 1 site in Egypt.
Trial summary
Sepsis accounts for high morbidity and mortality rates in ICU globally. Early recognition of sepsis with appropriate antimicrobial therapy is critical for the appropriate management of patients (1). Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Sepsis
- What is being tested?
- direct reporting of time to positivity of blood culture to ICU to know its effect to patients managment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Mar 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 to 18 years
- All sexes
- Child, Adult
Study population: The population of our study were patients in ICU unit in pediatric hospital of Assuit University Hospitals, that presented with clinical symptoms which may lead to a suspicion of a bloodstream infection or sepsis which is: * Undetermined fever ( ≥ 38°C) or hypothermia ( ≤ 36°C). * Shock, chills, rigors * Severe local infections (meningitis, endocarditis, pneumonia, pyelonephritis, intra-abdominal suppuration etc.)
Who may be able to join
- The population of our study were patients in ICU unit in pediatric hospital of Assuit University Hospitals, that presented with clinical symptoms which may lead to a suspicion of a bloodstream infection or sepsis which is:
- Undetermined fever ( ≥ 38°C) or hypothermia ( ≤ 36°C).
- Shock, chills, rigors
- Severe local infections (meningitis, endocarditis, pneumonia, pyelonephritis, intra-abdominal suppuration etc.) Multiple episodes of bacteremia per patient were allowed if the antimicrobial therapy for the previous episode had been completed and clinical and microbiological cure had been achieved
Who cannot join
- -blood culture bottles that were drawn in vacation days (because of no distinct control on transportation time, which affect TTP)
Trial locations and contacts
1 site in 1 country.
About this study
Sepsis accounts for high morbidity and mortality rates in ICU globally. Early recognition of sepsis with appropriate antimicrobial therapy is critical for the appropriate management of patients (1).
Blood culture (BC) is considered the gold standard for sepsis etiological diagnosis , with good sensitivity ,but suffering usually of delay or even failure to detect microorganisms in patients already treated with antimicrobials and failure to identify pathogens other than bacteria or yeast (2, 3).
Read more
Time-to-positivity (TTP) of blood cultures is defined as the time from the start of incubation to a positive signal. Knowledge of the distribution of blood culture TTP is of clinical benefit in the re-evaluation of patients with a clinical syndrome consistent with infection. A low probability of bacteremia when blood cultures have remained negative after 24 hours (4). Positive episodes with TTP more than or equal 24 h are commonly optimally treated infections, catheter-related infections, or infections caused by slowly growing microorganisms such as Candida or anaerobic Gram-negative bacteria. Growth of multidrug-resistant Gram-negative bacilli is exceptional beyond 24 h. In current clinical practice, bacteremia is considered unlikely if blood cultures have been negative for 48-72 hours (5, 6). Most blood culture bottles turn positive in less than 4 days, shortening the duration of incubation appears the most relevant solution in order to free additional capacity(4).
Various disinfectants, such as povidone iodine (PVI), alcohol preparations, and chlorhexidine gluconate ethanol (CHG-ALC), are used for disinfection prior to blood culture sampling. Contamination rates of cultured blood samples vary according to the disinfectant used, sampling site, definition of contamination, and skill level of individuals performing the venipuncture.(7, 8)
In this study, Investigators assessed the real life clinical impact on septic ICU patients based on time of blood culture positivity time.
Read the detailed description
Aim(s) of the Research :
- Evaluate the impact of blood culture positivity time in real -life clinical practice (patient management and reduction of ICU stay, as well as decreases in 30-days mortality.)
- Investigates the probability of blood culture positivity after 24 hours.
- evaluate if there was diagnostic value of TTP
- Identify if there is difference in the blood culture contamination rate between uses of various type of disinfectant.
Sample Size Calculation: 120 septic patient in pediatric intensive care unit
Study tools:
The following will be done to all patients:
Data collection:
Clinical data (were retrieved from the medical records) :
- age and weight
- Date and time of culture collection
- pre-existing medical conditions (concomitant disease).
- Clinical parameters at presentation. The most likely source of bacteremia
- if start empirical antibiotic treatment before collection or not and its type, duration (concomitant antimicrobial therapy)
- volume of blood drawn in the bottles
- outcome data. Including change of antibiotic treatment and time to switch to directed therapy, length of ICU stay and 30-day mortality.
Microbiological data (were retrieved from the database of the Department of Medical Microbiology.) :
- date and time of bottle loading ( to know transportation time)
- date and time in which growth was first reported
- TTP(time to positivity of blood culture)
- Pathogen detected by blood culture
Blood culture sampling :
- collecting blood samples as soon as possible after the onset of clinical symptoms, ideally prior the administering antimicrobial therapy.
- Disinfection using povidone-iodine, alcohol preparation, or chlorhexidine gluconate ethanol (CHG-ALC ), so that each type was used on 40 patients
- collect 2 sets of blood culture bottles. blood culture was obtained either at one time or over a brief time period (e.g. within 1 hour) from multiple venipuncture sites.
- Blood for culture must be collected and dispensed aseptically with great care to avoid contaminating the specimen and culture medium
Blood culture handling procedures and laboratory techniques:
- Rapid transportation to microbiology unit.
- Rapid bottle loading in bioMerieux BacT/Alert Virtuo where it was incubated for 5 days
- Direct Gram stain was performed for all positive blood culture bottles.
- Followed by subculture onto solid agar media, including blood agar, chocolate agar \& MacConkey agar and sabaroud agar (Diagnostic Media products(DMP). Then identification of microorganisms and antibiotic susceptibility by Vitek 2.
- Direct reporting method to the pediatric intensive care unit
- The presence of one of the following microorganisms in a single BC bottle or Blood Culture set was considered as contaminant: coagulase-negative staphylococci (CoNS), with the exception of S. lugdunensis, Propionibacterium spp., Bacillus spp. other than B. anthracis, Corynebacterium spp. (diphtheroids), Aerococcus-like organisms, Micrococcus spp., viridans group streptococci other than S. pneumoniae, and Neisseria spp. other than N. gonorrhoeae or N. meningitidis. These microorganisms were considered as significant when other BC bottles collected 48h before were positive with the same microorganism, after reviewing of clinical data.
- Conditions
- Sepsis
- Being tested
- direct reporting of time to positivity of blood culture to ICU to know its effect to patients managment
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct reporting of time to positivity of blood culture to ICU to know its effect to patients managmentDiagnostic test
Also called use different type of disinfectants (povidone iodine (PVI), alcohol preparations, and chlorhexidine gluconate ethanol (CHG-ALC)
-Disinfection using povidone-iodine, alcohol preparation or chlorhexidine gluconate ethanol (CHG-ALC ), so that each type was used on 40 patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the impact of blood culture positivity time in patient management and reduction of ICU stay, as well as decreases in 30-days mortality.
investigators measured the time to positivity of blood culture in hours. Then direct reporting the result to the physician ( as few true bloodstream infections were detected after 48 hours) ,,, Then study the impact of the result on therapeutic decisions (start of treatment, or switch or association of antibiotic/antifungal therapy). Then days of hospital stay were measured in the day unit\& mortality rate was measured in percentage
Measured: through study completion, an average of 1 year.
Investigates the probability of blood culture positivity after 24 hours.
time of positivity of blood culture measured in hours. It was calculated as the time from the start of incubation to a positive signal
Measured: through study completion, an average of 1 year.
evaluate if there was diagnostic value of TTP
see if there was a relationship between time of positivity of blood culture (in hour unit) and the type of microorganism,, and And if TTP can distinguish between contaminant and true pathogen
Measured: through study completion, an average of 1 year.
Identify if there is difference in the blood culture contamination rate between uses of various type of antiseptic.
Identify if there is a difference in the blood culture contamination rate (measured in percentage) between uses of various types of antiseptic.
Measured: through study completion, an average of 1 year.
Secondary outcomes (1)
- Identify if TTP in real life was superior to expensive modern microbiological techniques for the diagnosis of sepsis
expensive modern microbiological techniques for the diagnosis of sepsis are BioFire FilmArray Blood Culture Identification panel and T2 magnetic Resonance Bacterial Panel
Measured: through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Salah EL-Dein Hosney, Assiut University
- Investigators
- mohammed Z Abo krisha, professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507957
- Sponsor's protocol ID
- fatma elnaggar
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
endnote
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Blood Culture Positivity Time on Clinical Management of Pediatric ICU Patients
- ClinicalTrials.gov ID
- NCT05507957
- Acronym / sponsor ID
- fatma elnaggar
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 19 Aug 2022 (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.
Sepsis accounts for high morbidity and mortality rates in ICU globally. Early recognition of sepsis with appropriate antimicrobial therapy is critical for the appropriate management of patients (1).
Blood culture (BC) is considered the gold standard for sepsis etiological diagnosis , with good sensitivity ,but suffering usually of delay or even failure to detect microorganisms in patients already treated with antimicrobials and failure to identify pathogens other than bacteria or yeast (2, 3).
Time-to-positivity (TTP) of blood cultures is defined as the time from the start of incubation to a positive signal. Knowledge of the distribution of blood culture TTP is of clinical benefit in the re-evaluation of patients with a clinical syndrome consistent with infection. A low probability of bacteremia when blood cultures have remained negative after 24 hours (4). Positive episodes with TTP more than or equal 24 h are commonly optimally treated infections, catheter-related infections, or infections caused by slowly growing microorganisms such as Candida or anaerobic Gram-negative bacteria. Growth of multidrug-resistant Gram-negative bacilli is exceptional beyond 24 h. In current clinical practice, bacteremia is considered unlikely if blood cultures have been negative for 48-72 hours (5, 6). Most blood culture bottles turn positive in less than 4 days, shortening the duration of incubation appears the most relevant solution in order to free additional capacity(4).
Various disinfectants, such as povidone iodine (PVI), alcohol preparations, and chlorhexidine gluconate ethanol (CHG-ALC), are used for disinfection prior to blood culture sampling. Contamination rates of cultured blood samples vary according to the disinfectant used, sampling site, definition of contamination, and skill level of individuals performing the venipuncture.(7, 8)
In this study, Investigators assessed the real life clinical impact on septic ICU patients based on time of blood culture positivity time.
Detailed description
Aim(s) of the Research :
- Evaluate the impact of blood culture positivity time in real -life clinical practice (patient management and reduction of ICU stay, as well as decreases in 30-days mortality.)
- Investigates the probability of blood culture positivity after 24 hours.
- evaluate if there was diagnostic value of TTP
- Identify if there is difference in the blood culture contamination rate between uses of various type of disinfectant.
Sample Size Calculation: 120 septic patient in pediatric intensive care unit
Study tools:
The following will be done to all patients:
Data collection:
Clinical data (were retrieved from the medical records) :
- age and weight
- Date and time of culture collection
- pre-existing medical conditions (concomitant disease).
- Clinical parameters at presentation. The most likely source of bacteremia
- if start empirical antibiotic treatment before collection or not and its type, duration (concomitant antimicrobial therapy)
- volume of blood drawn in the bottles
- outcome data. Including change of antibiotic treatment and time to switch to directed therapy, length of ICU stay and 30-day mortality.
Microbiological data (were retrieved from the database of the Department of Medical Microbiology.) :
- date and time of bottle loading ( to know transportation time)
- date and time in which growth was first reported
- TTP(time to positivity of blood culture)
- Pathogen detected by blood culture
Blood culture sampling :
- collecting blood samples as soon as possible after the onset of clinical symptoms, ideally prior the administering antimicrobial therapy.
- Disinfection using povidone-iodine, alcohol preparation, or chlorhexidine gluconate ethanol (CHG-ALC ), so that each type was used on 40 patients
- collect 2 sets of blood culture bottles. blood culture was obtained either at one time or over a brief time period (e.g. within 1 hour) from multiple venipuncture sites.
- Blood for culture must be collected and dispensed aseptically with great care to avoid contaminating the specimen and culture medium
Blood culture handling procedures and laboratory techniques:
- Rapid transportation to microbiology unit.
- Rapid bottle loading in bioMerieux BacT/Alert Virtuo where it was incubated for 5 days
- Direct Gram stain was performed for all positive blood culture bottles.
- Followed by subculture onto solid agar media, including blood agar, chocolate agar \& MacConkey agar and sabaroud agar (Diagnostic Media products(DMP). Then identification of microorganisms and antibiotic susceptibility by Vitek 2.
- Direct reporting method to the pediatric intensive care unit
- The presence of one of the following microorganisms in a single BC bottle or Blood Culture set was considered as contaminant: coagulase-negative staphylococci (CoNS), with the exception of S. lugdunensis, Propionibacterium spp., Bacillus spp. other than B. anthracis, Corynebacterium spp. (diphtheroids), Aerococcus-like organisms, Micrococcus spp., viridans group streptococci other than S. pneumoniae, and Neisseria spp. other than N. gonorrhoeae or N. meningitidis. These microorganisms were considered as significant when other BC bottles collected 48h before were positive with the same microorganism, after reviewing of clinical data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- The population of our study were patients in ICU unit in pediatric hospital of Assuit University Hospitals, that presented with clinical symptoms which may lead to a suspicion of a bloodstream infection or sepsis which is: * Undetermined fever ( ≥ 38°C) or hypothermia ( ≤ 36°C). * Shock, chills, rigors * Severe local infections (meningitis, endocarditis, pneumonia, pyelonephritis, intra-abdominal suppuration etc.)
Key inclusion criteria (4 listed)
- The population of our study were patients in ICU unit in pediatric hospital of Assuit University Hospitals, that presented with clinical symptoms which may lead to a suspicion of a bloodstream infection or sepsis which is:
Key exclusion criteria (1 listed)
- -blood culture bottles that were drawn in vacation days (because of no distinct control on transportation time, which affect TTP)
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 |
|---|---|---|
| direct reporting of time to positivity of blood culture to ICU to know its effect to patients managmentAlso: use different type of disinfectants (povidone iodine (PVI), alcohol preparations, and chlorhexidine gluconate ethanol (CHG-ALC)-Disinfection using povidone-iodine, alcohol preparation or chlorhexidine gluconate ethanol (CHG-ALC ), so that each type was used on 40 patients | Diagnostic test | – |
Primary outcome
Evaluate the impact of blood culture positivity time in patient management and reduction of ICU stay, as well as decreases in 30-days mortality.
Time frame: through study completion, an average of 1 year.
investigators measured the time to positivity of blood culture in hours. Then direct reporting the result to the physician ( as few true bloodstream infections were detected after 48 hours) ,,, Then study the impact of the result on therapeutic decisions (start of treatment, or switch or association of antibiotic/antifungal therapy). Then days of hospital stay were measured in the day unit\& mortality rate was measured in percentage
Investigates the probability of blood culture positivity after 24 hours.
Time frame: through study completion, an average of 1 year.
time of positivity of blood culture measured in hours. It was calculated as the time from the start of incubation to a positive signal
evaluate if there was diagnostic value of TTP
Time frame: through study completion, an average of 1 year.
see if there was a relationship between time of positivity of blood culture (in hour unit) and the type of microorganism,, and And if TTP can distinguish between contaminant and true pathogen
Identify if there is difference in the blood culture contamination rate between uses of various type of antiseptic.
Time frame: through study completion, an average of 1 year.
Identify if there is a difference in the blood culture contamination rate (measured in percentage) between uses of various types of antiseptic.
1 secondary outcome
- Identify if TTP in real life was superior to expensive modern microbiological techniques for the diagnosis of sepsis
Time frame: through study completion, an average of 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Results publicationendnote
- Seasonal variations in blood culture numbers and time to positivity and potential impact of reducing incubation periodsLink provided by the sponsor.
- Time to positivity of blood cultures in patients with bloodstream infections: A useful prognostic toolLink provided by the sponsor.
- Neither Blood Culture Positivity nor Time to Positivity Is Associated With Mortality Among Patients Presenting With Severe Manifestations of Sepsis: The FABLED Cohort StudyLink provided by the sponsor.
- Chlorhexidine alcohol versus povidone-iodine: The comparative study of skin disinfectants at the blood transfusion centers of IranLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
mohammed Z Abo krisha, professor principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Assiut University at 1 site 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 4 inclusion and 1 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 24 Aug 2022. 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 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?
Contact fatma s elnaggar, master (+201065074152, hythamfatma142@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the impact of blood culture positivity time in patient management and reduction of ICU stay, as well as decreases in 30-days mortality. (time frame: through study completion, an average of 1 year.). The study lists 4 primary outcomes in all. 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 NCT05507957, which also lists 1 linked publication.
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 24 Aug 2022.