Clinical and Microbiological Outcomes of Infections Due to Carbapenem-Resistant Gram-Negative Bacteria

Drug Resistance, Microbial Clinical Trial

Official title:

Clinical and Microbiological Outcomes of Infections Due to Carbapenem-Resistant Gram-Negative Bacteria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041716
• Other study ID #: 09/11VA03
• Status: Completed
• Phase: N/A
• First received: December 30, 2009
• Last updated: August 18, 2011
• Start date: December 2009
• Est. completion date: December 2010

Study information

• Verified date: August 2011
• Source: Maimonides Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Carbapenems are a class of antibiotic agents which kill a broad spectrum of bacteria. Infections due to gram-negative bacteria which have acquired resistance to carbapenems are increasing, especially with Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa . The optimal treatment of such infections is not known. Antibiotics like polymyxin, tigecycline and rifampin are used alone or in combination with other antibiotics. The outcome of using these new and old drugs is not well studied. This observational study aims to study the clinical and microbiological outcomes of these infections and treatment at our institution.

Description:

Objectives

1. To define the demographic and risk factor profile of patients acquiring CRGNB infection.

2. To define the characteristics of CRGNB infection.

3. To report the different treatments employed for CRGNB infection.

4. To report the microbiological and clinical outcomes of different treatment options

• a. Microbiological outcomes: frequency of microbiological success. Microbiological success will be defined as two successive negative cultures from the same site as from where the CRGNB was originally isolated.

• b. Clinical outcomes: clinical success (clinical cure), adverse effects of treatment especially the nephrotoxicity in relation to the use of polymyxin, ICU length of stay (if applicable), hospital length of stay, ICU mortality (if applicable), hospital mortality and in-hospital recurrence of infection. Clinical success will be defined as resolution or improvement of clinical symptoms and signs of infection and discontinuation of the antibiotics.

Study duration:

We plan to collect the data for a one year period. Based on the current prevalence rate at our institution, we anticipate having data for 300 patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult in-patients (age=18 years) having an infection due to CRGNB (Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa only). CRGNB Infection will be defined as isolation of CRGNB from any source requiring treatment with anti-infective agents with or without manifestations of systemic inflammatory response syndrome.

Exclusion Criteria:

• Patients colonized with CRGNB and not having an active infection.

• Recurrent infection in a previously included patient.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Drug Resistance, Microbial

Intervention

Other:
• None - Observational study
None - Observational study

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Maimonides Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

Bradford PA, Bratu S, Urban C, Visalli M, Mariano N, Landman D, Rahal JJ, Brooks S, Cebular S, Quale J. Emergence of carbapenem-resistant Klebsiella species possessing the class A carbapenem-hydrolyzing KPC-2 and inhibitor-resistant TEM-30 beta-lactamases in New York City. Clin Infect Dis. 2004 Jul 1;39(1):55-60. Epub 2004 Jun 14. — View Citation

Bratu S, Landman D, Haag R, Recco R, Eramo A, Alam M, Quale J. Rapid spread of carbapenem-resistant Klebsiella pneumoniae in New York City: a new threat to our antibiotic armamentarium. Arch Intern Med. 2005 Jun 27;165(12):1430-5. — View Citation

Bratu S, Tolaney P, Karumudi U, Quale J, Mooty M, Nichani S, Landman D. Carbapenemase-producing Klebsiella pneumoniae in Brooklyn, NY: molecular epidemiology and in vitro activity of polymyxin B and other agents. J Antimicrob Chemother. 2005 Jul;56(1):128-32. Epub 2005 May 25. — View Citation

Patel G, Huprikar S, Factor SH, Jenkins SG, Calfee DP. Outcomes of carbapenem-resistant Klebsiella pneumoniae infection and the impact of antimicrobial and adjunctive therapies. Infect Control Hosp Epidemiol. 2008 Dec;29(12):1099-106. doi: 10.1086/592412. — View Citation

Weisenberg SA, Morgan DJ, Espinal-Witter R, Larone DH. Clinical outcomes of patients with Klebsiella pneumoniae carbapenemase-producing K. pneumoniae after treatment with imipenem or meropenem. Diagn Microbiol Infect Dis. 2009 Jun;64(2):233-5. doi: 10.1016/j.diagmicrobio.2009.02.004. Epub 2009 Apr 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical success	Resolution (or improvement) of clinical symptoms and signs of infection and discontinuation of the antibiotics.	At the end of treatment	No
Secondary	Microbiological success	Two successive negative cultures from the same site as the original pathogen was isolated.	At the end of treatment	Yes
Secondary	Recurrence rate	Recurrence of symptoms and signs of infection from the same organism and reinstituion of antibiotic therapy	During the hospital stay	Yes
Secondary	Adverse effects of treatment	Adverse effects related to antibiotic administration, especially nephrotoxic and neurotoxic effects of polymyxin	During treatment with antibiotics	Yes
Secondary	Hospital length of stay	Number of days hospitalized	During the hospital stay	Yes
Secondary	Mortality	All cause mortality during hospital stay	During hospital stay	Yes