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

Status Completed

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.

Clinical Trial 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Drug Resistance, Microbial

• NCT number: NCT01041716
• Study type: Observational
• Source: Maimonides Medical Center
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Completion date: December 2010