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

Completed

• Conditions: Drug Resistance, Microbial

• Registration Number: NCT01041716
• Lead Sponsor: Maimonides Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-30
• Study First Submitted QC: 2009-12-31
• Study First Posted: 2010-01-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-18
• Last Update Posted: 2011-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical success	At the end of treatment	Resolution (or improvement) of clinical symptoms and signs of infection and discontinuation of the antibiotics.

Secondary Outcome Measures

Name	Time	Method
Mortality	During hospital stay	All cause mortality during hospital stay
Microbiological success	At the end of treatment	Two successive negative cultures from the same site as the original pathogen was isolated.
Recurrence rate	During the hospital stay	Recurrence of symptoms and signs of infection from the same organism and reinstituion of antibiotic therapy
Adverse effects of treatment	During treatment with antibiotics	Adverse effects related to antibiotic administration, especially nephrotoxic and neurotoxic effects of polymyxin
Hospital length of stay	During the hospital stay	Number of days hospitalized

Trial Locations

Locations (1)

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States