Clinical and Microbiological Outcomes of Infections Due to Carbapenem-Resistant Gram-Negative Bacteria
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Clinical and Microbiological Outcomes of Infections Due to Carbapenem-Resistant Gram-Negative Bacteria|
- Clinical success [ Time Frame: At the end of treatment ] [ Designated as safety issue: No ]Resolution (or improvement) of clinical symptoms and signs of infection and discontinuation of the antibiotics.
- Microbiological success [ Time Frame: At the end of treatment ] [ Designated as safety issue: Yes ]Two successive negative cultures from the same site as the original pathogen was isolated.
- Recurrence rate [ Time Frame: During the hospital stay ] [ Designated as safety issue: Yes ]Recurrence of symptoms and signs of infection from the same organism and reinstituion of antibiotic therapy
- Adverse effects of treatment [ Time Frame: During treatment with antibiotics ] [ Designated as safety issue: Yes ]Adverse effects related to antibiotic administration, especially nephrotoxic and neurotoxic effects of polymyxin
- Hospital length of stay [ Time Frame: During the hospital stay ] [ Designated as safety issue: Yes ]Number of days hospitalized
- Mortality [ Time Frame: During hospital stay ] [ Designated as safety issue: Yes ]All cause mortality during hospital stay
|Study Start Date:||December 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Other: None - Observational study
- To define the demographic and risk factor profile of patients acquiring CRGNB infection.
- To define the characteristics of CRGNB infection.
- To report the different treatments employed for CRGNB infection.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041716
|United States, New York|
|Maimonides Medical Center|
|Brooklyn, New York, United States, 11219|
|Principal Investigator:||Sriharsha Rao, M.D.||Maimonides Medical Center|