Trial · NCT05102162
BL Infusion Trial:Beta-lactam Continuous Versus Intermittent Infusion and Associated Bacterial Resistance and Therapy Outcomes in Critically Ill Patients With Severe Pneumonia
NCT05102162, Phase 4, Terminated, University of Florida; results first posted 2023-12-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BL Infusion Trial:Beta-lactam Continuous Versus Intermittent Infusion and Associated Bacterial Resistance and Therapy Outcomes in Critically Ill Patients With Severe Pneumonia. Trials, record NCT05102162. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05102162
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BL Infusion Trial:Beta-lactam Continuous Versus Intermittent Infusion and Associated Bacterial Resistance and Therapy Outcomes in Critically Ill Patients With Severe Pneumonia
- NCT number
- NCT05102162
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 35 participants, actual
- Lead sponsor
- University of Florida
- Conditions
- Pneumonia
- Interventions
- Cefepime, Meropenem, or Piperacillin/Tazobactam, Cefepime, Meropenem, or Piperacillin/Tazobactam
- First posted
- 2021-11-01
- Last updated
- 2023-12-12
- Results first posted
- 2023-12-12
- Limitations and caveats
* Early termination leading to a small sample size and under-powered study.~* Repeat positive cultures may have been due to colonization and not active infection, especially in participants demonstrating clinical cure prior to repeat cultures.~* This study used MICs, which are generally accepted to have variability with repeat assessments, potentially up to 200% or more.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Gram-negative Bacterial Resistance Emergence Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | 4 weeks | 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. |
| Secondary | Superinfection Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens. | 4 weeks | 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. |
| Secondary | Microbiologic Eradication Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | 4 weeks | 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. |
| Secondary | Clinical Cure at Day 7 of Therapy Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | 7 Days | 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. |
| Secondary | Clinical Cure at the End of Therapy Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | 4 weeks | 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. |
| Secondary | Mortality Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | 4 weeks | |
| Secondary | Hospital Length of Stay Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens. | 4 weeks (may extend beyond depending on patient length of stay in hospital) | |
| Secondary | Intensive Care Unit (ICU) Length of Stay Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | 4 weeks (may extend beyond depending on patient length of stay in ICU) | |
| 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 | 4 weeks | 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. |
| 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 | 4 weeks | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Gram-negative Bacterial Resistance Emergence Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | 4 weeks | 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. | Bacteria isolates | NUMBER |
| SECONDARY | Superinfection Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens. | 4 weeks | 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. | Bacteria isolates | NUMBER |
| SECONDARY | Microbiologic Eradication Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | 4 weeks | 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. | Bacteria isolates | NUMBER |
| SECONDARY | Clinical Cure at Day 7 of Therapy Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | 7 Days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clinical Cure at the End of Therapy Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | 4 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mortality Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | 4 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Hospital Length of Stay Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens. | 4 weeks (may extend beyond depending on patient length of stay in hospital) | Days | MEDIAN | |
| SECONDARY | Intensive Care Unit (ICU) Length of Stay Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | 4 weeks (may extend beyond depending on patient length of stay in ICU) | Days | MEDIAN | |
| 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 | 4 weeks | Percentage of time | MEDIAN | |
| 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 | 4 weeks | Percentage of time | MEDIAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Gram-negative Bacterial Resistance Emergence Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | Continuous Antibiotic Dose Over 24 Hours Arm | 4 | Bacteria isolates | ||
| Gram-negative Bacterial Resistance Emergence Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | Intermittent Antibiotic Dose Over 30 Minutes | 8 | Bacteria isolates | ||
| Superinfection Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens. | Continuous Antibiotic Dose Over 24 Hours Arm | 0 | Bacteria isolates | ||
| Superinfection Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens. | Intermittent Antibiotic Dose Over 30 Minutes | 0 | Bacteria isolates | ||
| Microbiologic Eradication Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | Continuous Antibiotic Dose Over 24 Hours Arm | 1 | Bacteria isolates | ||
| Microbiologic Eradication Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | Intermittent Antibiotic Dose Over 30 Minutes | 4 | Bacteria isolates | ||
| Clinical Cure at Day 7 of Therapy Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | Continuous Antibiotic Dose Over 24 Hours Arm | 0 | Participants | ||
| Clinical Cure at Day 7 of Therapy Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | Intermittent Antibiotic Dose Over 30 Minutes | 5 | Participants | ||
| Clinical Cure at the End of Therapy Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | Continuous Antibiotic Dose Over 24 Hours Arm | 3 | Participants | ||
| Clinical Cure at the End of Therapy Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | Intermittent Antibiotic Dose Over 30 Minutes | 8 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Continuous Antibiotic Dose Over 24 Hours Arm | 19 | |
| Overall Study | STARTED | Intermittent Antibiotic Dose Over 30 Minutes | 16 | |
| Overall Study | COMPLETED | Continuous Antibiotic Dose Over 24 Hours Arm | 5 | |
| Overall Study | COMPLETED | Intermittent Antibiotic Dose Over 30 Minutes | 13 | |
| Overall Study | NOT COMPLETED | Continuous Antibiotic Dose Over 24 Hours Arm | 14 | |
| Overall Study | NOT COMPLETED | Intermittent Antibiotic Dose Over 30 Minutes | 3 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Continuous Antibiotic Dose Over 24 Hours Arm | 2 | 19 |
| Total, all-cause mortality | Intermittent Antibiotic Dose Over 30 Minutes | 2 | 16 |
| Total, other adverse events | Continuous Antibiotic Dose Over 24 Hours Arm | 0 | 19 |
| Total, other adverse events | Intermittent Antibiotic Dose Over 30 Minutes | 0 | 16 |
| Total, serious adverse events | Continuous Antibiotic Dose Over 24 Hours Arm | 0 | 19 |
| Total, serious adverse events | Intermittent Antibiotic Dose Over 30 Minutes | 0 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Continuous Antibiotic Dose Over 24 Hours Arm vs Intermittent Antibiotic Dose Over 30 Minutes: Mortality Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | Trial comparisons |
Continuous Antibiotic Dose Over 24 Hours Arm vs Intermittent Antibiotic Dose Over 30 Minutes: Clinical Cure at Day 7 of Therapy Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | Trial comparisons |
| Continuous Antibiotic Dose Over 24 Hours Arm vs Intermittent Antibiotic Dose Over 30 Minutes: deaths from any cause | Trial comparisons |
Continuous Antibiotic Dose Over 24 Hours Arm vs Intermittent Antibiotic Dose Over 30 Minutes: Clinical Cure at the End of Therapy Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens | Trial comparisons |
| Continuous Antibiotic Dose Over 24 Hours Arm vs Intermittent Antibiotic Dose Over 30 Minutes: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05102162
GET https://conductscience.org/api/trials/v1/NCT05102162/registered