Clinical and Microbiological Outcomes of Infections Due to Carbapenem-Resistant Gram-Negative Bacteria
|ClinicalTrials.gov Identifier: NCT01041716|
Recruitment Status : Completed
First Posted : January 1, 2010
Last Update Posted : August 19, 2011
|Condition or disease||Intervention/treatment|
|Drug Resistance, Microbial||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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Clinical and Microbiological Outcomes of Infections Due to Carbapenem-Resistant Gram-Negative Bacteria|
|Study Start Date :||December 2009|
|Primary Completion Date :||December 2010|
|Study Completion Date :||December 2010|
Other: None - Observational study
- Clinical success [ Time Frame: At the end of treatment ]Resolution (or improvement) of clinical symptoms and signs of infection and discontinuation of the antibiotics.
- Microbiological success [ Time Frame: At the end of treatment ]Two successive negative cultures from the same site as the original pathogen was isolated.
- Recurrence rate [ Time Frame: During the hospital stay ]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 ]Adverse effects related to antibiotic administration, especially nephrotoxic and neurotoxic effects of polymyxin
- Hospital length of stay [ Time Frame: During the hospital stay ]Number of days hospitalized
- Mortality [ Time Frame: During hospital stay ]All cause mortality during hospital stay
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01041716
|United States, New York|
|Maimonides Medical Center|
|Brooklyn, New York, United States, 11219|
|Principal Investigator:||Sriharsha Rao, M.D.||Maimonides Medical Center|