NCT05139628

Brief Summary

The aim of this work is to:

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
1.6 years until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

November 18, 2021

Last Update Submit

February 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Isolate and identify the organisms causing CRBSIs and perform antimicrobial sensitivity testing of the isolated organisms.

    1 year (Anticipated)

Interventions

Samples will be plated on blood culture plates and will be confirmed biochemically. Complete Bacteriological diagnosis will be done. The TTP of each BC bottle will be recorded

Eligibility Criteria

Age40 Days - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • El-Mahallawy H, Sidhom I, El-Din NH, Zamzam M, El-Lamie MM. Clinical and microbiologic determinants of serious bloodstream infections in Egyptian pediatric cancer patients: a one-year study. Int J Infect Dis. 2005 Jan;9(1):43-51. doi: 10.1016/j.ijid.2003.11.010.

    PMID: 15603994BACKGROUND
  • Gaur A, Giannini MA, Flynn PM, Boudreaux JW, Mestemacher MA, Shenep JL, Hayden RT. Optimizing blood culture practices in pediatric immunocompromised patients: evaluation of media types and blood culture volume. Pediatr Infect Dis J. 2003 Jun;22(6):545-52. doi: 10.1097/01.inf.0000069762.44241.0d.

    PMID: 12799512BACKGROUND
  • Grice EA, Segre JA. The skin microbiome. Nat Rev Microbiol. 2011 Apr;9(4):244-53. doi: 10.1038/nrmicro2537.

    PMID: 21407241BACKGROUND
  • Hughes WT, Armstrong D, Bodey GP, Brown AE, Edwards JE, Feld R, Pizzo P, Rolston KV, Shenep JL, Young LS. 1997 guidelines for the use of antimicrobial agents in neutropenic patients with unexplained fever. Infectious Diseases Society of America. Clin Infect Dis. 1997 Sep;25(3):551-73. doi: 10.1086/513764.

    PMID: 9314442BACKGROUND
  • Kong HH. Skin microbiome: genomics-based insights into the diversity and role of skin microbes. Trends Mol Med. 2011 Jun;17(6):320-8. doi: 10.1016/j.molmed.2011.01.013. Epub 2011 Mar 4.

    PMID: 21376666BACKGROUND
  • Maki DG, Weise CE, Sarafin HW. A semiquantitative culture method for identifying intravenous-catheter-related infection. N Engl J Med. 1977 Jun 9;296(23):1305-9. doi: 10.1056/NEJM197706092962301.

    PMID: 323710BACKGROUND
  • Norgaard M, Larsson H, Pedersen G, Schonheyder HC, Sorensen HT. Haematological malignancies--a predictor of a poor outcome in patients with bacteraemia. J Infect. 2006 Sep;53(3):190-8. doi: 10.1016/j.jinf.2005.10.024. Epub 2005 Dec 13.

    PMID: 16352338BACKGROUND
  • Rickard CM, Marsh N, Webster J, Runnegar N, Larsen E, McGrail MR, Fullerton F, Bettington E, Whitty JA, Choudhury MA, Tuffaha H, Corley A, McMillan DJ, Fraser JF, Marshall AP, Playford EG. Dressings and securements for the prevention of peripheral intravenous catheter failure in adults (SAVE): a pragmatic, randomised controlled, superiority trial. Lancet. 2018 Aug 4;392(10145):419-430. doi: 10.1016/S0140-6736(18)31380-1. Epub 2018 Jul 26.

    PMID: 30057103BACKGROUND
  • Safdar N, Maki DG. The pathogenesis of catheter-related bloodstream infection with noncuffed short-term central venous catheters. Intensive Care Med. 2004 Jan;30(1):62-7. doi: 10.1007/s00134-003-2045-z. Epub 2003 Nov 26.

    PMID: 14647886BACKGROUND
  • Sato A, Nakamura I, Fujita H, Tsukimori A, Kobayashi T, Fukushima S, Fujii T, Matsumoto T. Peripheral venous catheter-related bloodstream infection is associated with severe complications and potential death: a retrospective observational study. BMC Infect Dis. 2017 Jun 17;17(1):434. doi: 10.1186/s12879-017-2536-0.

    PMID: 28623882BACKGROUND
  • Soifer NE, Borzak S, Edlin BR, Weinstein RA. Prevention of peripheral venous catheter complications with an intravenous therapy team: a randomized controlled trial. Arch Intern Med. 1998 Mar 9;158(5):473-7. doi: 10.1001/archinte.158.5.473.

    PMID: 9508225BACKGROUND
  • Webster J, Osborne S, Rickard CM, Marsh N. Clinically-indicated replacement versus routine replacement of peripheral venous catheters. Cochrane Database Syst Rev. 2019 Jan 23;1(1):CD007798. doi: 10.1002/14651858.CD007798.pub5.

    PMID: 30671926BACKGROUND
  • Wisplinghoff H, Seifert H, Wenzel RP, Edmond MB. Current trends in the epidemiology of nosocomial bloodstream infections in patients with hematological malignancies and solid neoplasms in hospitals in the United States. Clin Infect Dis. 2003 May 1;36(9):1103-10. doi: 10.1086/374339. Epub 2003 Apr 14.

    PMID: 12715303BACKGROUND

MeSH Terms

Conditions

Catheter-Related Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Nahla M Elsherbiny, Prof. Dr.

    Professor of Medical Microbiology and Immunology Faculty of Medicine - Assiut University

    STUDY DIRECTOR
  • Mona H Abdel-Rahim, A. prof.

    Assistant professor of Medical Microbiology and Immunology

    STUDY DIRECTOR

Central Study Contacts

Mariam M AbdelHafeez, MBBS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

November 18, 2021

First Posted

December 1, 2021

Study Start

July 1, 2023

Primary Completion

December 1, 2023

Study Completion

July 1, 2024

Last Updated

March 2, 2022

Record last verified: 2022-02