Drug Resistance, Microbial
Conditions
Keywords
Carbapenem, Klebsiella pneumoniae carbapenemase, Acinetobacter baumannii, Pseudomonas aeruginosa
Brief 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.
Detailed 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.
Interventions
None - Observational study
Sponsors
Maimonides Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success | At the end of treatment | Resolution (or improvement) of clinical symptoms and signs of infection and discontinuation of the antibiotics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological success | At the end of treatment | Two successive negative cultures from the same site as the original pathogen was isolated. |
| Recurrence rate | During the hospital stay | Recurrence of symptoms and signs of infection from the same organism and reinstituion of antibiotic therapy |
| Adverse effects of treatment | During treatment with antibiotics | Adverse effects related to antibiotic administration, especially nephrotoxic and neurotoxic effects of polymyxin |
| Hospital length of stay | During the hospital stay | Number of days hospitalized |
| Mortality | During hospital stay | All cause mortality during hospital stay |
Countries
United States
Outcome results
None listed