Nurse's RoleNCT06336837
False Positive Peripheral Blood Culture in Children With Leukaemia: A Prevalence Study
An observational study of Nurse's Role and Leukemia, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Chemotherapy, the main treatment for childhood leukemia, has side effects on healthy cells. One of the most important of these side effects is the risk of infection due to neutropenia. In clinics, blood culture is the gold standard for the detection of possible infection risk (bacteremia, fungemia, etc.). Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Nurse's Role, Leukemia
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 1 Jun 2024
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children in the 0-18 age group who have been treated for leukaemia as inpatients in the paediatric hermatology oncology clinic and from whom peripheral blood culture was taken for any reason will be included in the study.
Who may be able to join
- within the time interval of the study being a patient between the ages of 0-18,
- not having any other disease other than leukaemia,
- having received inpatient chemotherapy treatment in PHO
- having a peripheral blood culture test taken from the patient,
- the patient's culture results being accessible through the hospital information system.
Who cannot join
- the patient was hospitalised in the clinic outside the time frame of the study,
- a diagnosis other than leukaemia
- peripheral blood culture was not taken from the patient or the results could not be accessed through the hospital information system
Trial locations and contacts
1 site in 1 country.
About this study
Chemotherapy, the main treatment for childhood leukemia, has side effects on healthy cells. One of the most important of these side effects is the risk of infection due to neutropenia. In clinics, blood culture is the gold standard for the detection of possible infection risk (bacteremia, fungemia, etc.). During the diagnosis and treatment process in children with leukemia, a large number of peripheral or catheter blood cultures are performed. When the culture results are positive, it is accepted that the infection has grown. In some cases, a positive peripheral blood culture result may not be clinically significant. An agent belonging to the skin flora of the patient or the healthcare professional taking the field culture may also cause the blood culture result to be positive. This is called contamination or false positive blood culture. Contaminated cultures may cause prolonged hospitalization, additional medical interventions, unnecessary initiation of antibiotic treatment and related antibiotic resistance, toxicity due to additional drugs and an increase in hospital costs. The peripheral blood culture contamination rate, which is accepted as a quality indicator in some countries, should be below 3%.
In this context, this study aimed to determine the prevalence of false positive peripheral blood cultures by examining the peripheral blood culture results obtained during routine follow-ups from children hospitalized with leukemia in the pediatric hematology clinic. The data will be collected retrospectively covering three years before March 2024 when the ethics committee approval was obtained. Since the relevant clinic cares for approximately 25 new children diagnosed with leukemia annually, the study sample is planned as 75 cases.
Read the detailed description
A positive peripheral blood culture does not always mean that the individual has a systemic infection. In some cases, a positive blood culture result may also be seen in the event of contamination with the skin flora of the person receiving/receiving the culture. This is called a false positive blood culture. This situation is characterised as a situation that reduces the reliability of the test. Contaminated false positive blood culture is a single culture bottle containing microorganisms belonging to the skin flora (Coagulase Negative Staphylococcus [Staphylococcus epidermidis, Staphylococcus hominis, Staphylococcus capitis, Staphylococcus haemolyticus], Viridans streptococci, Aerococcus, Micrococcus, Propionibacterium spp, Bacillus spp., [except B. Anthracis], Corynebacterium spp. and alpha-gamma haemolytic streptococci, Dermabacter spp., Rothia spp. and Kocuria spp.)
In cases where bacteria grow in blood culture media, it is necessary to distinguish between local skin flora and true pathogenic bacteria. Contaminated culture results in prolonged hospital stay, additional tests, unnecessary exposure of the patient to antimicrobial agents and increased risk of other complications (qualitative change in microorganisms, increased colonisation rates with drug-resistant organisms such as VRE and MRSA, increased Clostridium difficile infection rates). Inappropriate antibiotherapies initiated due to contaminated blood culture results may cause toxic side effects in the patient. One of the most serious negative effects of inappropriately used antibiotics is the development of antibiotic resistance. Due to the large-scale use of inappropriate antibiotics in hospitals, nosocomial flora undergoes a change. This change leads to the disappearance of susceptible microorganisms in the flora and the increase in resistant strains.
In this context, the aim of this study was to determine the prevalence of false positive peripheral blood cultures by retrospectively examining the peripheral blood culture results obtained during routine follow-up from children hospitalised with leukaemia in the paediatric haematology clinic.
Type of Research Quantitative | Descriptive | Archive Search
Population and Sample The population of the research will consist of children who received chemotherapy due to leukemia treatment and whose peripheral blood culture was taken during routine treatment. The sample will consist of pediatric patients who were hospitalized in the Hematology Department Clinic of Ege University Faculty of Medicine Children's Hospital between March 2021 and March 2024 (after the approval of the Ethics Committee, retrospectively from the month of approval (3 years)). Since the number of inpatient cases diagnosed with leukemia in the Pediatric Hematology Clinic is approximately 25 cases per year, it is planned to examine the peripheral blood culture results of 75 different cases in three years.
- Conditions
- Nurse's Role, Leukemia
- Keywords
- blood cultures, contamination, nurses
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No arm used. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood culture contamination rate
false positive peripheral blood culture
Measured: three year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start15 Mar 2024
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- More trials run by Ege 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEDA ARDAHAN SEVGİLİ, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336837
- Sponsor's protocol ID
- 24-3T/48
- Status last verified
- Jul 2024
- First submitted
- 22 Mar 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- False Positive Peripheral Blood Culture in Children With Leukaemia: A Prevalence Study
- ClinicalTrials.gov ID
- NCT06336837
- Acronym / sponsor ID
- 24-3T/48
- Conditions
- Nurse's Role, Leukemia
- Keywords
- blood cultures, contamination, nurses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 29 Mar 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.
Chemotherapy, the main treatment for childhood leukemia, has side effects on healthy cells. One of the most important of these side effects is the risk of infection due to neutropenia. In clinics, blood culture is the gold standard for the detection of possible infection risk (bacteremia, fungemia, etc.). During the diagnosis and treatment process in children with leukemia, a large number of peripheral or catheter blood cultures are performed. When the culture results are positive, it is accepted that the infection has grown. In some cases, a positive peripheral blood culture result may not be clinically significant. An agent belonging to the skin flora of the patient or the healthcare professional taking the field culture may also cause the blood culture result to be positive. This is called contamination or false positive blood culture. Contaminated cultures may cause prolonged hospitalization, additional medical interventions, unnecessary initiation of antibiotic treatment and related antibiotic resistance, toxicity due to additional drugs and an increase in hospital costs. The peripheral blood culture contamination rate, which is accepted as a quality indicator in some countries, should be below 3%.
In this context, this study aimed to determine the prevalence of false positive peripheral blood cultures by examining the peripheral blood culture results obtained during routine follow-ups from children hospitalized with leukemia in the pediatric hematology clinic. The data will be collected retrospectively covering three years before March 2024 when the ethics committee approval was obtained. Since the relevant clinic cares for approximately 25 new children diagnosed with leukemia annually, the study sample is planned as 75 cases.
Detailed description
A positive peripheral blood culture does not always mean that the individual has a systemic infection. In some cases, a positive blood culture result may also be seen in the event of contamination with the skin flora of the person receiving/receiving the culture. This is called a false positive blood culture. This situation is characterised as a situation that reduces the reliability of the test. Contaminated false positive blood culture is a single culture bottle containing microorganisms belonging to the skin flora (Coagulase Negative Staphylococcus [Staphylococcus epidermidis, Staphylococcus hominis, Staphylococcus capitis, Staphylococcus haemolyticus], Viridans streptococci, Aerococcus, Micrococcus, Propionibacterium spp, Bacillus spp., [except B. Anthracis], Corynebacterium spp. and alpha-gamma haemolytic streptococci, Dermabacter spp., Rothia spp. and Kocuria spp.)
In cases where bacteria grow in blood culture media, it is necessary to distinguish between local skin flora and true pathogenic bacteria. Contaminated culture results in prolonged hospital stay, additional tests, unnecessary exposure of the patient to antimicrobial agents and increased risk of other complications (qualitative change in microorganisms, increased colonisation rates with drug-resistant organisms such as VRE and MRSA, increased Clostridium difficile infection rates). Inappropriate antibiotherapies initiated due to contaminated blood culture results may cause toxic side effects in the patient. One of the most serious negative effects of inappropriately used antibiotics is the development of antibiotic resistance. Due to the large-scale use of inappropriate antibiotics in hospitals, nosocomial flora undergoes a change. This change leads to the disappearance of susceptible microorganisms in the flora and the increase in resistant strains.
In this context, the aim of this study was to determine the prevalence of false positive peripheral blood cultures by retrospectively examining the peripheral blood culture results obtained during routine follow-up from children hospitalised with leukaemia in the paediatric haematology clinic.
Type of Research Quantitative | Descriptive | Archive Search
Population and Sample The population of the research will consist of children who received chemotherapy due to leukemia treatment and whose peripheral blood culture was taken during routine treatment. The sample will consist of pediatric patients who were hospitalized in the Hematology Department Clinic of Ege University Faculty of Medicine Children's Hospital between March 2021 and March 2024 (after the approval of the Ethics Committee, retrospectively from the month of approval (3 years)). Since the number of inpatient cases diagnosed with leukemia in the Pediatric Hematology Clinic is approximately 25 cases per year, it is planned to examine the peripheral blood culture results of 75 different cases in three years.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No arm used. | – | – |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children in the 0-18 age group who have been treated for leukaemia as inpatients in the paediatric hermatology oncology clinic and from whom peripheral blood culture was taken for any reason will be included in the study.
Key inclusion criteria (5 listed)
- within the time interval of the study being a patient between the ages of 0-18,
- not having any other disease other than leukaemia,
- having received inpatient chemotherapy treatment in PHO
- having a peripheral blood culture test taken from the patient,
- the patient's culture results being accessible through the hospital information system.
Key exclusion criteria (3 listed)
- the patient was hospitalised in the clinic outside the time frame of the study,
- a diagnosis other than leukaemia
- peripheral blood culture was not taken from the patient or the results could not be accessed through the hospital information system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
blood culture contamination rate
Time frame: three year period
false positive peripheral blood culture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nurse's Role and Leukemia, run by Ege University at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 3 Jul 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood culture contamination rate (time frame: three year period). 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 3 Jul 2024.