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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

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

Conditions
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Drug Resistance, Microbial

Intervention / Treatment
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* Other: None - Observational study


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: None - Observational study|None - Observational study|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carbapenem, Klebsiella pneumoniae carbapenemase, Acinetobacter baumannii, Pseudomonas aeruginosa