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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.
Objectives
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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| None - Observational study | Other | None - Observational study |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success | Resolution (or improvement) of clinical symptoms and signs of infection and discontinuation of the antibiotics. | At the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological success | Two successive negative cultures from the same site as the original pathogen was isolated. | At the end of treatment |
| Recurrence rate | Recurrence of symptoms and signs of infection from the same organism and reinstituion of antibiotic therapy |
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Inclusion Criteria:
Exclusion Criteria:
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Adult in-patients (age≥18 years) having an infection due to CRGNB (Klebsiella pneumoniae, Acinitobacter baumanii 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.
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| Name | Affiliation | Role |
|---|---|---|
| Sriharsha Rao, M.D. | Maimonides Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15206053 | Background | 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. doi: 10.1086/421495. Epub 2004 Jun 14. | |
| 15983294 |
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| ID | Term |
|---|---|
| D011552 | Pseudomonas Infections |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| During the hospital stay |
| Adverse effects of treatment | Adverse effects related to antibiotic administration, especially nephrotoxic and neurotoxic effects of polymyxin | During treatment with antibiotics |
| Hospital length of stay | Number of days hospitalized | During the hospital stay |
| Mortality | All cause mortality during hospital stay | During hospital stay |
| 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. doi: 10.1001/archinte.165.12.1430. |
| 18973455 | Background | 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. |
| 19345034 | Background | 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. |
| 15917285 | Background | 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. doi: 10.1093/jac/dki175. Epub 2005 May 25. |