Trial · NCT01570192
Clinical Trials to Reduce the Risk of Antimicrobial Resistance
NCT01570192, Phase 2, Terminated, University of Florida; results first posted 2017-04-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Trials to Reduce the Risk of Antimicrobial Resistance. Trials, record NCT01570192. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01570192
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trials to Reduce the Risk of Antimicrobial Resistance
- NCT number
- NCT01570192
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- University of Florida
- Conditions
- Bacterial Pneumonia
- Interventions
IV meropenem, I.V. Meropenem, Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h, Linezolid or Vancomycin (per institutional guidelines) will be available for MRSA coverage., tobramycin nebulization
- First posted
- 2012-04-04
- Last updated
- 2017-09-29
- Results first posted
- 2017-04-20
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Suppression and Emergence of Resistance | up to 28 days after enrollment | The emergence of resistance is defined as a change of meropenem MIC or aminoglycoside MIC by two tube dilutions (fourfold) from baseline when assessed at the second BAL procedure on day 5/early extubation. Patients are evaluable for this endpoint IF they had baseline BAL and Day 5/early extubation and if they had positive cultures on baseline and Day/EE. |
| Secondary | Clinical Response | End of treatment - up to 28 days after enrollment | Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N) |
| Secondary | Clinical Response in Subjects Who Received Prior Antibiotics | End of treatment - up to 28 days after enrollment | Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N) |
| Secondary | Overall Microbiologic Response | End of treatment - up to 28 days after enrollment | Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N) |
| Secondary | Pretreatment Pathogen Response | End of treatment - up to 28 days after enrollment | Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N) |
| Secondary | Suppression of the Emergence of Resistance in Other Gram-negative Pathogens | Day 5/Early Extubation | Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N) |
| Secondary | Occurrence of Repeat Negative Cultures | Day 5/Early Extubation | Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N) |
| Secondary | Mortality | 14 days | Percentage of patients who died by efficacy endpoint, treatment group and population (n/N) |
| Secondary | Mortality | 28 days | Percentage of patients who died by efficacy endpoint, treatment group and population (n/N) |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Suppression and Emergence of Resistance | up to 28 days after enrollment | All patients in the ME population with BAL at baseline and at Day 5/EE and pathogens collected at baseline BAL and at Day 5/EE BAL. | participants | NUMBER |
| SECONDARY | Clinical Response | End of treatment - up to 28 days after enrollment | The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Response in Subjects Who Received Prior Antibiotics | End of treatment - up to 28 days after enrollment | The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Microbiologic Response | End of treatment - up to 28 days after enrollment | The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pretreatment Pathogen Response | End of treatment - up to 28 days after enrollment | The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Suppression of the Emergence of Resistance in Other Gram-negative Pathogens | Day 5/Early Extubation | The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Occurrence of Repeat Negative Cultures | Day 5/Early Extubation | The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mortality | 14 days | The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mortality | 28 days | The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Suppression and Emergence of Resistance | I.V. Meropenem | suppression of emergence of resistance | 5 | participants | |
| Number of Participants With Suppression and Emergence of Resistance | I.V. Meropenem | emergence of resistance | 1 | participants | |
| Clinical Response | ME Group - Meropenem Plus Aminoglycoside | 2 | Participants | ||
| Clinical Response | MEGroup - Meropenem Only | 8 | Participants | ||
| Clinical Response | m-MITT Group - Meropenem Plus Aminoglycoside | 2 | Participants | ||
| Clinical Response | m-MITT Group - Meropenem Only | 8 | Participants | ||
| Clinical Response in Subjects Who Received Prior Antibiotics | ME Group - Meropenem Plus Aminoglycoside | 1 | Participants | ||
| Clinical Response in Subjects Who Received Prior Antibiotics | ME Group - Meropenem Only | 2 | Participants | ||
| Clinical Response in Subjects Who Received Prior Antibiotics | m-MITT Group - Meropenem Plus Aminoglycoside | 1 | Participants | ||
| Clinical Response in Subjects Who Received Prior Antibiotics | m-MITT Group - Meropenem Only | 2 | Participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IV Meropenem; Parenteral Aminoglycoside | 13 | |
| Overall Study | STARTED | I.V. Meropenem | 30 | |
| Overall Study | COMPLETED | IV Meropenem; Parenteral Aminoglycoside | 6 | |
| Overall Study | COMPLETED | I.V. Meropenem | 17 | |
| Overall Study | NOT COMPLETED | IV Meropenem; Parenteral Aminoglycoside | 7 | |
| Overall Study | NOT COMPLETED | I.V. Meropenem | 13 |
Source ClinicalTrials.gov
Adverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | cutaneous eruption | Skin and subcutaneous tissue disorders | IV Meropenem; Parenteral Aminoglycoside | 0 | 13 | 0 |
| serious | cutaneous eruption | Skin and subcutaneous tissue disorders | I.V. Meropenem | 1 | 30 | 1 |
| serious | reinforced duodenal ulcer | Gastrointestinal disorders | IV Meropenem; Parenteral Aminoglycoside | 1 | 13 | 1 |
| serious | reinforced duodenal ulcer | Gastrointestinal disorders | I.V. Meropenem | 0 | 30 | 0 |
| serious | pneomonia | Respiratory, thoracic and mediastinal disorders | IV Meropenem; Parenteral Aminoglycoside | 1 | 13 | 1 |
| serious | pneomonia | Respiratory, thoracic and mediastinal disorders | I.V. Meropenem | 1 | 30 | 1 |
| serious | cardiogenic shock | Cardiac disorders | IV Meropenem; Parenteral Aminoglycoside | 0 | 13 | 0 |
| serious | cardiogenic shock | Cardiac disorders | I.V. Meropenem | 1 | 30 | 1 |
| serious | cardiac arrest | Cardiac disorders | IV Meropenem; Parenteral Aminoglycoside | 1 | 13 | 1 |
| serious | cardiac arrest | Cardiac disorders | I.V. Meropenem | 1 | 30 | 1 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IV Meropenem; Parenteral Aminoglycoside | ||
| Total, all-cause mortality | I.V. Meropenem | ||
| Total, other adverse events | IV Meropenem; Parenteral Aminoglycoside | 0 | 13 |
| Total, other adverse events | I.V. Meropenem | 0 | 30 |
| Total, serious adverse events | IV Meropenem; Parenteral Aminoglycoside | 6 | 13 |
| Total, serious adverse events | I.V. Meropenem | 11 | 30 |
Source ClinicalTrials.gov
Papers26
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| IV Meropenem; Parenteral Aminoglycoside vs I.V. Meropenem: serious adverse events |
Source 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/NCT01570192
GET https://conductscience.org/api/trials/v1/NCT01570192/results?page=2