| Primary | Gram-negative Bacterial Resistance Emergence Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | Bacterial resistance is defined as new numeric increases (>/=2 fold) in the bacterial MIC during the follow-up period compared to the baseline when starting beta-lactam therapy. MICs were collected from respiratory samples and compared from study enrollment to end of the follow-up period for at least a 2 fold increase in MIC. | The number of participants included in the analysis was 18. However, for the primary outcome measure, the bacteria isolates were analyzed for emergence of resistance. We were able to include 18 isolates in the intermittent infusion arm and 8 in the continuous infusion arm. | Posted | | Number | | Bacteria isolates | | 4 weeks | Bacteria isolates | Bacteria isolates | | ID | Title | Description |
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| OG000 | Continuous Antibiotic Dose Over 24 Hours Arm | Subjects will be receiving a continuous dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) | | OG001 | Intermittent Antibiotic Dose Over 30 Minutes | Subjects will be receiving an intermittent dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) |
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| Secondary | Superinfection Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens. | Superinfection is defined as the growth of resistant Gram-negative bacteria during the follow-up period which was not isolated in baseline culture. Respiratory cultures during the follow up period were assessed for Gram-negative isolates resistant to the beta-lactams of interest that were not present in the initial respiratory cultures. | The number of participants included in the analysis was 18. However, for superinfection, the bacteria isolates were analyzed. We were able to include 18 Gram-negative isolates in the intermittent infusion arm and 8 Gram-negative isolates in the continuous infusion arm. | Posted | | Number | | Bacteria isolates | | 4 weeks | Bacteria Isolates | Bacteria Isolates | | ID | Title | Description |
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| OG000 | Continuous Antibiotic Dose Over 24 Hours Arm | Subjects will be receiving a continuous dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) | | OG001 | Intermittent Antibiotic Dose Over 30 Minutes | Subjects will be receiving an intermittent dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) |
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| Secondary | Microbiologic Eradication Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | Microbiologic eradication is defined as the absence of bacterial growth during the follow-up period with no subsequent positive culture from any site. Respiratory cultures during the follow up period were assessed for the absence of bacterial growth. | For microbiologic eradication, the bacteria isolates were analyzed. We were able to include 18 Gram-negative isolates in the intermittent infusion arm and 8 Gram-negative isolates in the continuous infusion arm. | Posted | | Number | | Bacteria isolates | | 4 weeks | Bacteria Isolates | Bacteria Isolates | | ID | Title | Description |
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| OG000 | Continuous Antibiotic Dose Over 24 Hours Arm | Subjects will be receiving a continuous dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) | | OG001 | Intermittent Antibiotic Dose Over 30 Minutes | Subjects will be receiving an intermittent dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) |
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| Secondary | Clinical Cure at Day 7 of Therapy Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | Clinical cure is the resolution of infection-related symptoms at day 7 of therapy, including normalization of body temperature and white blood cell (WBC) count and taking the patient off mechanical ventilation or vasopressors, and non-initiation of a new antibiotic within 48 hours of stopping the original antibiotic. | | Posted | | Count of Participants | | Participants | | 7 Days | | | | ID | Title | Description |
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| OG000 | Continuous Antibiotic Dose Over 24 Hours Arm | Subjects will be receiving a continuous dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) | | OG001 | Intermittent Antibiotic Dose Over 30 Minutes | Subjects will be receiving an intermittent dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) |
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| Secondary | Clinical Cure at the End of Therapy Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | Clinical cure is the resolution of infection-related symptoms at the end of therapy, including normalization of body temperature and white blood cell (WBC) count and taking the patient off mechanical ventilation or vasopressors, and non-initiation of a new antibiotic within 48 hours of stopping the original antibiotic. End of therapy could occur up to 4 weeks after enrollment. | | Posted | | Count of Participants | | Participants | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Continuous Antibiotic Dose Over 24 Hours Arm | Subjects will be receiving a continuous dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) | | OG001 | Intermittent Antibiotic Dose Over 30 Minutes | Subjects will be receiving an intermittent dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) |
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| Secondary | Mortality Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | | | Posted | | Count of Participants | | Participants | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Continuous Antibiotic Dose Over 24 Hours Arm | Subjects will be receiving a continuous dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) | | OG001 | Intermittent Antibiotic Dose Over 30 Minutes | Subjects will be receiving an intermittent dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) |
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| Secondary | Hospital Length of Stay Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens. | | | Posted | | Median | Inter-Quartile Range | Days | | 4 weeks (may extend beyond depending on patient length of stay in hospital) | | | | ID | Title | Description |
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| OG000 | Continuous Antibiotic Dose Over 24 Hours Arm | Subjects will be receiving a continuous dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) | | OG001 | Intermittent Antibiotic Dose Over 30 Minutes | Subjects will be receiving an intermittent dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) |
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| Secondary | Intensive Care Unit (ICU) Length of Stay Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | | | Posted | | Median | Inter-Quartile Range | Days | | 4 weeks (may extend beyond depending on patient length of stay in ICU) | | | | ID | Title | Description |
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| OG000 | Continuous Antibiotic Dose Over 24 Hours Arm | Subjects will be receiving a continuous dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) | | OG001 | Intermittent Antibiotic Dose Over 30 Minutes | Subjects will be receiving an intermittent dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) |
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| Secondary | Percent of Time Free Drug Concentrations Remain Above the Minimum Inhibitory Concentration (%fT>MIC) in the Dosing Interval Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | Beta-lactam bactericidal efficacy depends upon the percentage of time that free drug concentrations remain above the minimum inhibitory concentration (%fT>MIC) of the pathogen within the dosing interval. Pre-clinical animal studies demonstrate 40-70% fT>MIC is needed for adequate bacterial killing. However, clinical studies suggest higher exposures may be needed, potentially 100%fT>MIC to 100%fT>4xMIC. Patients had beta-lactam concentrations measured as part of therapeutic drug monitoring. Drug exposures were determined using a Bayesian-based software. Infusion arms were compared to determine if %fT>MIC was different between infusion arms. | | Posted | | Median | Inter-Quartile Range | Percentage of time | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Continuous Antibiotic Dose Over 24 Hours Arm | Subjects will be receiving a continuous dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) | | OG001 | Intermittent Antibiotic Dose Over 30 Minutes | Subjects will be receiving an intermittent dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) |
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| Secondary | Percent of Time Free Drug Concentrations Remain Above Four Multiples of the Minimum Inhibitory Concentration (%fT>4xMIC) in the Dosing Interval Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | Beta-lactam bactericidal efficacy depends upon the percentage of time that free drug concentrations remain above the minimum inhibitory concentration (%fT>MIC) of the pathogen within the dosing interval. Pre-clinical animal studies demonstrate 40-70% fT>MIC is needed for adequate bacterial killing. However, clinical studies suggest higher exposures may be needed, potentially 100%fT>MIC to 100%fT>4xMIC. Patients had beta-lactam concentrations measured as part of therapeutic drug monitoring. Drug exposures were determined using a Bayesian-based software. Infusion arms were compared to determine if %fT>4xMIC was different between infusion arms. | | Posted | | Median | Inter-Quartile Range | Percentage of time | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Continuous Antibiotic Dose Over 24 Hours Arm | Subjects will be receiving a continuous dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) | | OG001 | Intermittent Antibiotic Dose Over 30 Minutes | Subjects will be receiving an intermittent dose of antibiotic prescribed by their doctor for the duration they choose. Cefepime, Meropenem, or Piperacillin/Tazobactam: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam) |
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