Turkish Prospective Cohort Study on Carbapenem Resistant Klebsiella Pneumonia Bacteremia

NCT03597841 | Completed

• 1 other identifier: 2018.151.IRB1.018
• Study Type: observational
• Target: 278
• Locations: 1 country
• Sites: 15

Brief Summary

Carbapenem-resistant Klebsiella pneumonia (CRKp) blood stream infections (BSI) cause substantial mortality among hospitalized patients. Treatment options for CRKp infections are limited and increasing resistance rates to few available drugs, i.e., colistin, is a big concern. This prospective multicenter observational study is designed to describe clinical characteristics and outcomes of patients with CRKp bacteremia in an oxacillinase-48 (OXA-48) endemic country to define predictors of mortality with a focus on the impact of mono versus combination therapies on mortality. The study will also investigate risk factors associated with colistin-resistant CRKp BSI.

Conditions

Klebsiella Pneumonia; Bacteremia

Keywords

Monotherapy; Combination therapy; Colistin-resistant; Klebsiella Pneumonia; Bacteremia; Blood stream infection

Outcome Measures

Primary Outcomes (1)

• 30-day crude mortality

  Death by any cause

  1 month

Secondary Outcomes (11)

• In-hospital mortality

  1 month

• Clinical response at day 7 and 14

  day 7 and 14

• Microbiologic eradication

  day 3, 7 and/or 14

• Infection related mortality

  1 month

• Duration of hospital stay after infection

  1 month

Study Arms (2)

Patients with CRKp BSI:Combination therapy

Drug: Combination therapy

Patients with CRKp BSI: Monotherapy

Interventions

Combination therapy DRUG

Patients who are given combination therapy will be allocated to this group.

Patients with CRKp BSI:Combination therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult hospitalized patients (≥18 years old) with clinically significant CRKp bacteremia

You may qualify if:

• All adult patients (≥18 years old) with clinically significant CRKp bacteremia

You may not qualify if:

• Polymicrobial infection (except coagulase-negative staphylococci or other skin contaminants isolated from one blood culture bottle, which is considered contamination)
• Subsequent CRKp bacteremia episodes from the same patient

Sponsors & Collaborators

• Koç University: lead

Study Sites (15)

Ankara University

Ankara, Turkey (Türkiye)

Location

Başkent University

Ankara, Turkey (Türkiye)

Location

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Ministry of Health, Ankara Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Uluduağ University

Bursa, Turkey (Türkiye)

Location

American Hospital

Istanbul, Turkey (Türkiye)

Location

Cerrahpaşa University

Istanbul, Turkey (Türkiye)

Location

Istanbul Bilim University

Istanbul, Turkey (Türkiye)

Location

Istanbul Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

İstanbul Sultan Abdülhamid Han Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Koç University

Istanbul, Turkey (Türkiye)

Location

Marmara University

Istanbul, Turkey (Türkiye)

Location

Ministry of Health Okmeydanı Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Ministry Of Health, Kartal Koşuyolu High Speciality Educational and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Dokuz Eylül University

Izmir, Turkey (Türkiye)

Location

Related Publications (22)

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• Monaco M, Giani T, Raffone M, Arena F, Garcia-Fernandez A, Pollini S; Network EuSCAPE-Italy; Grundmann H, Pantosti A, Rossolini GM. Colistin resistance superimposed to endemic carbapenem-resistant Klebsiella pneumoniae: a rapidly evolving problem in Italy, November 2013 to April 2014. Euro Surveill. 2014 Oct 23;19(42):20939. doi: 10.2807/1560-7917.es2014.19.42.20939.

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• Hauck C, Cober E, Richter SS, Perez F, Salata RA, Kalayjian RC, Watkins RR, Scalera NM, Doi Y, Kaye KS, Evans S, Fowler VG Jr, Bonomo RA, van Duin D; Antibacterial Resistance Leadership Group. Spectrum of excess mortality due to carbapenem-resistant Klebsiella pneumoniae infections. Clin Microbiol Infect. 2016 Jun;22(6):513-9. doi: 10.1016/j.cmi.2016.01.023. Epub 2016 Feb 3.

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• Daikos GL, Tsaousi S, Tzouvelekis LS, Anyfantis I, Psichogiou M, Argyropoulou A, Stefanou I, Sypsa V, Miriagou V, Nepka M, Georgiadou S, Markogiannakis A, Goukos D, Skoutelis A. Carbapenemase-producing Klebsiella pneumoniae bloodstream infections: lowering mortality by antibiotic combination schemes and the role of carbapenems. Antimicrob Agents Chemother. 2014;58(4):2322-8. doi: 10.1128/AAC.02166-13. Epub 2014 Feb 10.

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• Tumbarello M, Viale P, Viscoli C, Trecarichi EM, Tumietto F, Marchese A, Spanu T, Ambretti S, Ginocchio F, Cristini F, Losito AR, Tedeschi S, Cauda R, Bassetti M. Predictors of mortality in bloodstream infections caused by Klebsiella pneumoniae carbapenemase-producing K. pneumoniae: importance of combination therapy. Clin Infect Dis. 2012 Oct;55(7):943-50. doi: 10.1093/cid/cis588. Epub 2012 Jul 2.

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• Rodriguez-Bano J, Gutierrez-Gutierrez B, Machuca I, Pascual A. Treatment of Infections Caused by Extended-Spectrum-Beta-Lactamase-, AmpC-, and Carbapenemase-Producing Enterobacteriaceae. Clin Microbiol Rev. 2018 Feb 14;31(2):e00079-17. doi: 10.1128/CMR.00079-17. Print 2018 Apr.

  PMID: 29444952 BACKGROUND

• Paul M, Carmeli Y, Durante-Mangoni E, Mouton JW, Tacconelli E, Theuretzbacher U, Mussini C, Leibovici L. Combination therapy for carbapenem-resistant Gram-negative bacteria. J Antimicrob Chemother. 2014 Sep;69(9):2305-9. doi: 10.1093/jac/dku168. Epub 2014 May 28.

  PMID: 24872346 BACKGROUND

• Zusman O, Altunin S, Koppel F, Dishon Benattar Y, Gedik H, Paul M. Polymyxin monotherapy or in combination against carbapenem-resistant bacteria: systematic review and meta-analysis. J Antimicrob Chemother. 2017 Jan;72(1):29-39. doi: 10.1093/jac/dkw377. Epub 2016 Sep 13.

  PMID: 27624572 BACKGROUND

• Gutierrez-Gutierrez B, Salamanca E, de Cueto M, Hsueh PR, Viale P, Pano-Pardo JR, Venditti M, Tumbarello M, Daikos G, Canton R, Doi Y, Tuon FF, Karaiskos I, Perez-Nadales E, Schwaber MJ, Azap OK, Souli M, Roilides E, Pournaras S, Akova M, Perez F, Bermejo J, Oliver A, Almela M, Lowman W, Almirante B, Bonomo RA, Carmeli Y, Paterson DL, Pascual A, Rodriguez-Bano J; REIPI/ESGBIS/INCREMENT Investigators. Effect of appropriate combination therapy on mortality of patients with bloodstream infections due to carbapenemase-producing Enterobacteriaceae (INCREMENT): a retrospective cohort study. Lancet Infect Dis. 2017 Jul;17(7):726-734. doi: 10.1016/S1473-3099(17)30228-1. Epub 2017 Apr 22.

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• Falcone M, Russo A, Iacovelli A, Restuccia G, Ceccarelli G, Giordano A, Farcomeni A, Morelli A, Venditti M. Predictors of outcome in ICU patients with septic shock caused by Klebsiella pneumoniae carbapenemase-producing K. pneumoniae. Clin Microbiol Infect. 2016 May;22(5):444-50. doi: 10.1016/j.cmi.2016.01.016. Epub 2016 Feb 3.

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MeSH Terms

Conditions

Bacteremia

Interventions

Combined Modality Therapy

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Burcu Isler, MD

  Sisli Hamidiye Etfal Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Önder Ergönül, MD

  Koç University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 24, 2018
• Study Start: June 25, 2018
• Primary Completion: June 25, 2019
• Study Completion: July 22, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

TU (15)