Development of Risk Score Model and Decision Tree Algorithm for Predicting Infections With CRKp in Colonized Patients

NCT04229511 | Unknown

• 1 other identifier: DETERMINE301219
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

Brief Summary

DETERMINE trial is a prospective multicenter multinational cohort study. This study will be carried out to predict the risk of bloodstream infections (BSIs) or other types of invasive infection with carbapenem resistant K.pneumoniae in patients being colonized by CRKp. The results of DETERMINE trial would be quite important to prevent unnecessary coverage of carbapenem resistant Klebsiella pneumoniae in empirical treatment of colonized patients. In this study, both risk score model and decision tree algorithm will be constructed and compared with each other in terms of sensitivity, specificity, positive predictive value and negative predictive value.

Conditions

Bloodstream Infection; Pneumonia, Bacterial; Intra-abdominal Infection; Urinary Tract Infections; Osteomyelitis; Central Nervous System Infections; Acute Bacterial Skin and Skin Structure Infection

Keywords

Carbapenem resistant Klebsiella pneumoniae; Colonization; Bloodstream Infections; Invasive Infections; Risk score model; Decision Tree Algorithm

Outcome Measures

Primary Outcomes (1)

• The factors that are associated with the development of subsequent BSI or other types of invasive infection with CRKp in CRKp carriers.

  The independent risk factors (eg. presence of central venous catheter and presence of absolute neutropenia) for development of BSI or other invasive infections wtihin 90-days follow-up in CRKp carriers will be analyzed by constructing mutli-variate logistic regression analysis model.

  90-day

Secondary Outcomes (2)

• Calculation of sensitivity and specificity rates, positive and negative predictive values of risk score model.

  90-day

• Calculation of sensitivity and specificity rates, positive and negative predictive values of decision tree algorithm.

  90-days

Study Arms (3)

Infection caused by CRKp

Group 1 cases are constituted by one BSI episode or non-bactereamic invasive infection episode (eg. pneumonia, intra-abdominal infection or urinary tract infection) with CRKp and a positive rectal swab screening or invasive infection (e.g. pneumonia, urinary tract infection and BSI) with CRKp within 90 days before identification of index BSI or other invasive infection with CRKp

Diagnostic Test: Detection of CRKp colonization

Infection caused by any other bacteria

Group 2 cases who are colonized with CRKp or had invasive infection (e.g. pneumonia, urinary tract infection and BSI) with CRKp within 90 days before identification of index BSI or other types of invasive infection with any bacteria other than CRKp and develop subsequent BSI or non-bactereamic invasive infection with these bacteria

Diagnostic Test: Detection of CRKp colonization

No infection

Group 3 cases involve the colonized patients with CRKp who do not develop subsequent BSI or other invasive infections with CRKp or any other bacteria

Diagnostic Test: Detection of CRKp colonization

Interventions

Detection of CRKp colonization DIAGNOSTIC_TEST

Detection of CRKp colonization will be performed in all participants by sceening with rectal swab

Infection caused by CRKp; Infection caused by any other bacteria; No infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult (≥18 years) patients having rectal colonization or history of previous invasive infection with CRKp within previous 90 days of index invasive infection

You may qualify if:

• All adult (≥18 years) patients having rectal colonization or history of previous invasive infection with CRKp
• Group 1 cases are constituted by one BSI episode or non-bactereamic invasive infection episode (eg. pneumonia, intra-abdominal infection or urinary tract infection) with CRKp and a positive rectal swab screening or invasive infection (e.g. pneumonia, urinary tract infection and BSI) with CRKp within 90 days before identification of index BSI or other invasive infection with CRKp
• Group 2 cases who are colonized with CRKp or had invasive infection (e.g. pneumonia, urinary tract infection and BSI) with CRKp within 90 days before identification of index BSI or other types of invasive infection with any bacteria other than CRKp and develop subsequent BSI or non-bactereamic invasive infection with these bacteria
• Group 3 cases involve the colonized patients with CRKp who do not develop subsequent BSI or other invasive infections with CRKp or any other bacteria

You may not qualify if:

• \<18 years old patients
• Palliative patients
• Pregnant and breast-feeding patients
• Patients who cannot be followed through 90-days.
• Patients who are de-colonized with antibiotics, prebiotics-probiotics or fecal microbiota transplantation

Sponsors & Collaborators

• SCARE (Study group for carbapenem resistance): lead

Study Sites (1)

Abdullah Tarık Aslan

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (7)

• Viale P, Giannella M, Lewis R, Trecarichi EM, Petrosillo N, Tumbarello M. Predictors of mortality in multidrug-resistant Klebsiella pneumoniae bloodstream infections. Expert Rev Anti Infect Ther. 2013 Oct;11(10):1053-63. doi: 10.1586/14787210.2013.836057. Epub 2013 Sep 27.

  PMID: 24073806 BACKGROUND

• Nguyen M, Eschenauer GA, Bryan M, O'Neil K, Furuya EY, Della-Latta P, Kubin CJ. Carbapenem-resistant Klebsiella pneumoniae bacteremia: factors correlated with clinical and microbiologic outcomes. Diagn Microbiol Infect Dis. 2010 Jun;67(2):180-4. doi: 10.1016/j.diagmicrobio.2010.02.001. Epub 2010 Mar 31.

  PMID: 20356699 BACKGROUND

• Zarkotou O, Pournaras S, Tselioti P, Dragoumanos V, Pitiriga V, Ranellou K, Prekates A, Themeli-Digalaki K, Tsakris A. Predictors of mortality in patients with bloodstream infections caused by KPC-producing Klebsiella pneumoniae and impact of appropriate antimicrobial treatment. Clin Microbiol Infect. 2011 Dec;17(12):1798-803. doi: 10.1111/j.1469-0691.2011.03514.x. Epub 2011 May 20.

  PMID: 21595793 BACKGROUND

• Qureshi ZA, Paterson DL, Potoski BA, Kilayko MC, Sandovsky G, Sordillo E, Polsky B, Adams-Haduch JM, Doi Y. Treatment outcome of bacteremia due to KPC-producing Klebsiella pneumoniae: superiority of combination antimicrobial regimens. Antimicrob Agents Chemother. 2012 Apr;56(4):2108-13. doi: 10.1128/AAC.06268-11. Epub 2012 Jan 17.

  PMID: 22252816 BACKGROUND

• Bonten MJ, Weinstein RA. The role of colonization in the pathogenesis of nosocomial infections. Infect Control Hosp Epidemiol. 1996 Mar;17(3):193-200. doi: 10.1086/647274.

  PMID: 8708364 BACKGROUND

• Madueno A, Gonzalez Garcia J, Aguirre-Jaime A, Lecuona M. A hospital-based matched case-control study to identify risk factors for clinical infection with OXA-48-producing Klebsiella pneumoniae in rectal carriers. Epidemiol Infect. 2017 Sep;145(12):2626-2630. doi: 10.1017/S095026881700142X. Epub 2017 Jul 17.

  PMID: 28712369 BACKGROUND

• Giannella M, Trecarichi EM, De Rosa FG, Del Bono V, Bassetti M, Lewis RE, Losito AR, Corcione S, Saffioti C, Bartoletti M, Maiuro G, Cardellino CS, Tedeschi S, Cauda R, Viscoli C, Viale P, Tumbarello M. Risk factors for carbapenem-resistant Klebsiella pneumoniae bloodstream infection among rectal carriers: a prospective observational multicentre study. Clin Microbiol Infect. 2014 Dec;20(12):1357-62. doi: 10.1111/1469-0691.12747. Epub 2014 Aug 11.

  PMID: 24980276 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Rectal swab samples for identification of colonization with CRKp Blood culture or other site culture samples for molecular and microbiological analysis

MeSH Terms

Conditions

Sepsis; Pneumonia, Bacterial; Intraabdominal Infections; Urinary Tract Infections; Osteomyelitis; Central Nervous System Infections

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Bone Diseases, Infectious; Bone Diseases; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Abdullah T Aslan, Dr.

  Hacettepe University

  STUDY DIRECTOR

Central Study Contacts

Abdullah T Aslan, Dr.

CONTACT

+905346754889; aslanabdullahtarik@gmail.com

Murat Akova, Prof. Dr.

CONTACT

+905323151845; akova.murat@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2020
• First Posted: January 18, 2020
• Study Start: April 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: November 1, 2021
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)