False Positive Peripheral Blood Culture in Children With Leukaemia: A Prevalence Study

NCT06336837 | Completed DMC

• 1 other identifier: 24-3T/48
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.). 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.

Conditions

Nurse's Role; Leukemia

Keywords

blood cultures; contamination; nurses

Outcome Measures

Primary Outcomes (1)

• blood culture contamination rate

  false positive peripheral blood culture

  three year period

Study Arms (1)

No arm used.

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, 35100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood culture bottles

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 29, 2024
• Study Start: March 15, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

TU (1)