Clinical trial NCT05139628: Peripheral Venous Catheter Related Blood Stream Infections
Official title: The Impact of Skin Colonization at the Peripheral Venous Catheter Insertion Sites on Catheter Tip Colonization and Catheter Related Blood Stream Infections Among Pediatric Oncology Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Catheter-Related Infections
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: • This study will be conducted on pediatric patients admitted to South Egypt Cancer Institute -Assiut University with more than 48hrs of catheter insertion.Patients ( age \> 40 days up to 18 years) from both sexes.

Brief summary: The aim of this work is to:

1. Study the impact of PIVC skin colonization on catheter tip colonization and the development of CRBSI
2. isolate and identify the organisms causing peripheral venous catheter related blood stream infections in pediatric oncology patients.
3. perform antimicrobial sensitivity testing of isolated organisms.
4. identify the associated risk factors that lead to CRBSIs in such group of patients.

Detailed description: Peripheral intravenous catheters (PIVCs) are small flexible tubes that are vital for the delivery of therapies, such as fluids, drugs, and blood transfusions that are required in up to 70% of hospitalized patients. The PIVC is introduced through the skin into the peripheral veins of the arms, hands, or lower limbs. Despite their relatively short-term use (typically \<1 week) they are a potential source of catheter-related bloodstream infections (CRBSIs) implicated in up to 5% of nosocomial bacteremias, with a prevalence of 0.67%-2.4 %. Such infections increase a patient's risk of death, discomfort, and length of hospital stay.

Among pediatric patients with hemato-oncologic disease, intravascular catheter-associated bloodstream infection is the most common cause of bloodstream infections leading to increased mortality and morbidity in such patients. The Mortality rates of bloodstream infections in patients with malignancy are significantly higher than in patients without malignancy. There is a paucity of data on blood stream infections (BSIs) generally amongst paediatric oncology patients in low and middle-income countries, and especially CRBSIs.

Cancer patients are predisposed to BSI for several reasons:

* Alterations in anatomic barriers, both internal and external leading to enhance access of bacteria and fungi to the bloodstream.
* Changes in both cell-mediated and humoral immunity occur related both to the primary tumor and the subsequent treatment.
* Infectious complications in pediatric hematology-oncology patients have been significantly associated with the presence of indwelling catheters.

With most clinical studies focusing on central vascular catheters, infections associated with short peripheral venous catheters have received little attention. While central line-associated bloodstream infections have become an important metric in assessing patient safety, peripheral intravenous catheters (PVCs) remain underappreciated as an intravascular device that is also responsible for catheter-associated bloodstream infections.

Catheter related bloodstream infection (CRBSI) is defined as the presence of bacteremia originating from an intravenous catheter. An estimated 60% of these CRBSIs are associated with the patient's skin flora.The skin is a complex environment that provides greater space for diverse commensal and pathogenic microbes. Catheter colonization occurs by progression of microorganisms to the tip of the catheter along either the inner surface (≥7 days of indwelling time) or the outer surface (\<7 days of indwelling time) of the catheter. Even despite skin site decontamination with antiseptic prior to PIVC insertion, bacteria may remain in the hair follicles and lower dermis, and immediately after post insertion catheter, the bacteria begin proliferation. If conditions are particularly favorable, for example moisture from diaphoresis, blood ooze, and numerous hair follicles, bacterial growth becomes faster. Skin bacteria can progressively colonize down the insertion site along the PIVC tract. However, the impact of PIVC skin site colonization on tip colonization and the development of CRBSI has never been investigated comprehensively.

Eligibility criteria: Inclusion Criteria:

* The following data will be collected for each patient :
* Age
* Sex
* Type of malignancy
* PIVC location
* Antimicrobial use
* Parenteral nutrition
* Dwell-time
* The reason for removal (eg, treatment complete, PIVC complications, or suspected infection, or routinely (72-96 hours).

Exclusion criteria:

* Patient with existing bloodstream infections.
* or those with any type of infections

Primary outcomes:
measure: Study the impact of Peripheral intravenous catheter skin colonization on catheter tip colonization and the development of Catheter related blood stream infections in pediatric oncology patients and Identify the associated risk factors.
timeFrame: 1 year (Anticipated)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Medical Microbiology and Immunology Faculty of Medicine - Assiut University
name: Nahla M Elsherbiny, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Assistant professor of Medical Microbiology and Immunology
name: Mona H Abdel-Rahim, A. prof.
role: STUDY_DIRECTOR
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