Catheter-Related InfectionsNCT05139628
Peripheral Venous Catheter Related Blood Stream Infections
An observational study of Catheter-Related Infections, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 days to 18 years
- Conditions the study is for
- Catheter-Related Infections
- What is being tested?
- microbiological identification of samples (skin and blood samples)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Jul 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 40 days to 18 years
- All sexes
- Child, Adult
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.
Who may be able to join
- The following data will be collected for each patient :
- Age
- Sex
- Type of malignancy
- PIVC location
- Antimicrobial use
Show all 9Show fewer
- Parenteral nutrition
- Dwell-time
- The reason for removal (eg, treatment complete, PIVC complications, or suspected infection, or routinely (72-96 hours).
Who cannot join
- Patient with existing bloodstream infections.
- or those with any type of infections
Trial locations and contacts
No sites are listed yet.
About this study
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.
The aim of this work is to:
- Study the impact of PIVC skin colonization on catheter tip colonization and the development of CRBSI
- isolate and identify the organisms causing peripheral venous catheter related blood stream infections in pediatric oncology patients.
- perform antimicrobial sensitivity testing of isolated organisms.
- identify the associated risk factors that lead to CRBSIs in such group of patients.
Read the 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.
- Conditions
- Catheter-Related Infections
- Being tested
- microbiological identification of samples (skin and blood samples)
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microbiological identification of samples (skin and blood samples)Diagnostic test
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year (Anticipated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Jul 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Catheter-Related InfectionsStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mohamed Abdel-Hafeez, Assiut University
- Investigators
- Nahla M Elsherbiny, Prof. Dr., Study director, Professor of Medical Microbiology and Immunology Faculty of Medicine - Assiut UniversityMona H Abdel-Rahim, A. prof., Study director, Assistant professor of Medical Microbiology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139628
- Sponsor's protocol ID
- PVC related BSIs
- Status last verified
- Feb 2022
- First submitted
- 18 Nov 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 15603994Gaur 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.
PubMed 12799512Grice EA, Segre JA. The skin microbiome. Nat Rev Microbiol. 2011 Apr;9(4):244-53. doi: 10.1038/nrmicro2537.
PubMed 21407241Hughes 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.
PubMed 9314442Kong 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.
PubMed 21376666Maki 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.
PubMed 323710Norgaard 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.
PubMed 16352338Rickard 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.
PubMed 30057103Safdar 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.
PubMed 14647886Sato 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.
PubMed 28623882Soifer 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.
PubMed 9508225Webster 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.
PubMed 30671926Wisplinghoff 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.
PubMed 12715303
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05139628
- Acronym / sponsor ID
- PVC related BSIs
- Conditions
- Catheter-Related Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 1 Dec 2021 (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.
The aim of this work is to:
- Study the impact of PIVC skin colonization on catheter tip colonization and the development of CRBSI
- isolate and identify the organisms causing peripheral venous catheter related blood stream infections in pediatric oncology patients.
- perform antimicrobial sensitivity testing of isolated organisms.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 days to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (9 listed)
- The following data will be collected for each patient :
- Age
- Sex
- Type of malignancy
- PIVC location
Key exclusion criteria (2 listed)
- Patient with existing bloodstream infections.
- or those with any type of infections
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 |
|---|---|---|
| microbiological identification of samples (skin and blood samples)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 | Diagnostic test | – |
Primary outcome
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.
Time frame: 1 year (Anticipated)
Isolate and identify the organisms causing CRBSIs and perform antimicrobial sensitivity testing of the isolated organisms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Background: PubMed 15603994El-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.
- Background: PubMed 12799512Gaur 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.
- Background: PubMed 21407241Grice EA, Segre JA. The skin microbiome. Nat Rev Microbiol. 2011 Apr;9(4):244-53. doi: 10.1038/nrmicro2537.
- Background: PubMed 9314442Hughes 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.
- Background: PubMed 21376666Kong 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.
- Background: PubMed 323710Maki 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.
- Background: PubMed 16352338Norgaard 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.
- Background: PubMed 30057103Rickard 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.
- Background: PubMed 14647886Safdar 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.
- Background: PubMed 28623882Sato 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.
- Background: PubMed 9508225Soifer 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.
- Background: PubMed 30671926Webster 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.
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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.
Nahla M Elsherbiny, Prof. Dr. study director
Professor of Medical Microbiology and Immunology Faculty of Medicine - Assiut University
Mona H Abdel-Rahim, A. prof. study director
Assistant professor of Medical Microbiology and Immunology
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter-Related Infections, run by Assiut University.
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 9 inclusion and 2 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 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Mariam M AbdelHafeez, MBBS (+201100862681, dr_mariam_h@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 1 year (Anticipated)). 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 NCT05139628, which also lists 13 linked publications.
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 2 Mar 2022.