Trial · NCT03485950
Comparative Study To Determine The Efficacy, Safety, And Tolerability Of Ceftolozane-Tazobactam
NCT03485950, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2021-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparative Study To Determine The Efficacy, Safety, And Tolerability Of Ceftolozane-Tazobactam. Trials, record NCT03485950. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03485950
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Study To Determine The Efficacy, Safety, And Tolerability Of Ceftolozane-Tazobactam
- NCT number
- NCT03485950
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Other Infectious Diseases
- Interventions
- Cefepime, Ceftolozane, Laboratory Biomarker Analysis, Meropenem, Piperacillin-Tazobactam, Tazobactam
- First posted
- 2018-04-03
- Last updated
- 2022-03-15
- Results first posted
- 2021-07-20
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV) | Within 72 hours after administration of the last dose of inpatient IV study drug | Resolution of all acute signs and symptoms of the primary infection or improvement to such an extent that no additional antibacterial therapy is required (ie, except for protocol-allowed adjunctive therapies and/or oral or IV switch) and such that no more than 14 days of total antibacterial therapy is required. |
| Secondary | Number of Participants With Favorable Clinical Response in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set at EOIV. | Within 72 hours after administration of the last dose of inpatient IV study drug. | The secondary efficacy outcome is favorable clinical response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
| Secondary | Number of Participants With Favorable Clinical Response in the Clinically Evaluable (CE) Analysis Set at EOIV. | Within 72 hours after administration of the last dose of inpatient IV study drug. | The secondary efficacy outcome is favorable clinical response of the patients in the CE (Clinically Evaluable) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
| Secondary | Number of Participants With Favorable Clinical Response in the MITT Analysis Set at TOC | 21 to 28 days after the start of inpatient IV study drug | The secondary efficacy outcome is favorable clinical response of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
| Secondary | Number of Participants With Favorable Clinical Response in the MITT Analysis Set at Late Follow-Up (LFU) | 35 to 42 days after the start of inpatient IV study drug | The secondary efficacy outcome is favorable clinical response of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
| Secondary | Number of Participants With Favorable Clinical Response in the mMITT Analysis Set at Test of Cure (TOC) | 21 to 28 days after the start of inpatient IV study drug. | The secondary efficacy outcome is favorable clinical response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
| Secondary | Number of Participants With Favorable Clinical Response in the mMITT Analysis Set at Late Follow-Up (LFU) | 35 to 42 days after the start of inpatient IV study drug | The secondary efficacy outcome is favorable clinical response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
| Secondary | Number of Participants With Favorable Clinical Response in the CE Analysis Set at TOC | 21 to 28 days after the start of inpatient IV study drug | The secondary efficacy outcome is favorable clinical response of the patients in the CE (Clinically Evaluable) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
| Secondary | Number of Participants With Favorable Clinical Response in the CE Analysis Set at LFU. | 35 to 42 days after the start of inpatient IV study drug | The secondary efficacy outcome is favorable clinical response of the patients in the CE (Clinically Evaluable) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
| Secondary | Number of Participants With Favorable Clinical Response in the ME Analysis Set at EOIV. | Within 72 hours after administration of the last dose of inpatient IV study drug. | The secondary efficacy outcome is favorable clinical response of the patients in the ME (Microbiologically Evaluable) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
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 Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV) | Within 72 hours after administration of the last dose of inpatient IV study drug | Patients in MITT (Modified Intent-To-Treat) Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Favorable Clinical Response in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set at EOIV. | Within 72 hours after administration of the last dose of inpatient IV study drug. | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Favorable Clinical Response in the Clinically Evaluable (CE) Analysis Set at EOIV. | Within 72 hours after administration of the last dose of inpatient IV study drug. | Patients in CE (Clinically Evaluable) Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Favorable Clinical Response in the MITT Analysis Set at TOC | 21 to 28 days after the start of inpatient IV study drug | Patients in the MITT (Modified Intent-To-Treat) Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Favorable Clinical Response in the MITT Analysis Set at Late Follow-Up (LFU) | 35 to 42 days after the start of inpatient IV study drug | Patients in the MITT (Modified Intent-To-Treat) Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Favorable Clinical Response in the mMITT Analysis Set at Test of Cure (TOC) | 21 to 28 days after the start of inpatient IV study drug. | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Favorable Clinical Response in the mMITT Analysis Set at Late Follow-Up (LFU) | 35 to 42 days after the start of inpatient IV study drug | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Favorable Clinical Response in the CE Analysis Set at TOC | 21 to 28 days after the start of inpatient IV study drug | Patients in CE (Clinically Evaluable) Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Favorable Clinical Response in the CE Analysis Set at LFU. | 35 to 42 days after the start of inpatient IV study drug | Patients in CE (Clinically Evaluable) Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Favorable Clinical Response in the ME Analysis Set at EOIV. | Within 72 hours after administration of the last dose of inpatient IV study drug. | Patients in CE analysis set with baseline Gram-negative pathogen (= ME (Microbiologically Evaluable) Analysis Set) | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group48
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 Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV) | Ceftolozane/Tazobactam Arm | 41 | Participants | ||
| Number of Participants With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV) | Standard of Care (SOC) Arm | 36 | Participants | ||
| Number of Participants With Favorable Clinical Response in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set at EOIV. | Ceftolozane/Tazobactam Arm | 3 | Participants | ||
| Number of Participants With Favorable Clinical Response in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set at EOIV. | Standard of Care (SOC) Arm | 1 | Participants | ||
| Number of Participants With Favorable Clinical Response in the Clinically Evaluable (CE) Analysis Set at EOIV. | Ceftolozane/Tazobactam Arm | 29 | Participants | ||
| Number of Participants With Favorable Clinical Response in the Clinically Evaluable (CE) Analysis Set at EOIV. | Standard of Care (SOC) Arm | 32 | Participants | ||
| Number of Participants With Favorable Clinical Response in the MITT Analysis Set at TOC | Ceftolozane/Tazobactam Arm | 34 | Participants | ||
| Number of Participants With Favorable Clinical Response in the MITT Analysis Set at TOC | Standard of Care (SOC) Arm | 28 | Participants | ||
| Number of Participants With Favorable Clinical Response in the MITT Analysis Set at Late Follow-Up (LFU) | Ceftolozane/Tazobactam Arm | 33 | Participants | ||
| Number of Participants With Favorable Clinical Response in the MITT Analysis Set at Late Follow-Up (LFU) | Standard of Care (SOC) Arm | 26 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ceftolozane/Tazobactam Arm | 50 | |
| Overall Study | STARTED | Standard of Care (SOC) Arm | 50 | |
| Overall Study | COMPLETED | Ceftolozane/Tazobactam Arm | 43 | |
| Overall Study | COMPLETED | Standard of Care (SOC) Arm | 48 | |
| Overall Study | NOT COMPLETED | Ceftolozane/Tazobactam Arm | 7 | |
| Overall Study | NOT COMPLETED | Standard of Care (SOC) Arm | 2 |
Source ClinicalTrials.gov
Adverse events92
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 |
|---|---|---|---|---|---|---|
| other | ALT elevation | Hepatobiliary disorders | Ceftolozane/Tazobactam Arm | 3 | 47 | |
| other | ALT elevation | Hepatobiliary disorders | Standard of Care (SOC) Arm | 3 | 50 | |
| other | Rash | Skin and subcutaneous tissue disorders | Ceftolozane/Tazobactam Arm | 4 | 47 | |
| other | Rash | Skin and subcutaneous tissue disorders | Standard of Care (SOC) Arm | 3 | 50 | |
| other | Urinary tract infection | Infections and infestations | Ceftolozane/Tazobactam Arm | 3 | 47 | |
| other | Urinary tract infection | Infections and infestations | Standard of Care (SOC) Arm | 0 | 50 | |
| serious | Back pain | Musculoskeletal and connective tissue disorders | Ceftolozane/Tazobactam Arm | 1 | 47 | |
| serious | Back pain | Musculoskeletal and connective tissue disorders | Standard of Care (SOC) Arm | 1 | 50 | |
| serious | Atrial fibrillation | Cardiac disorders | Ceftolozane/Tazobactam Arm | 1 | 47 | |
| serious | Atrial fibrillation | Cardiac disorders | Standard of Care (SOC) Arm | 0 | 50 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ceftolozane/Tazobactam Arm | 3 | 47 |
| Total, all-cause mortality | Standard of Care (SOC) Arm | 2 | 50 |
| Total, other adverse events | Ceftolozane/Tazobactam Arm | 9 | 47 |
| Total, other adverse events | Standard of Care (SOC) Arm | 6 | 50 |
| Total, serious adverse events | Ceftolozane/Tazobactam Arm | 33 | 47 |
| Total, serious adverse events | Standard of Care (SOC) Arm | 33 | 50 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35663286 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons26
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ceftolozane/Tazobactam Arm vs Standard of Care (SOC) Arm: Number of Participants With Favorable Clinical Response in the mMITT Analysis Set at Late Follow-Up (LFU) | Trial comparisons |
| Ceftolozane/Tazobactam Arm vs Standard of Care (SOC) Arm: Number of Participants With Infection-related Mortality in the MITT Analysis Set at LFU | Trial comparisons |
| Ceftolozane/Tazobactam Arm vs Standard of Care (SOC) Arm: Number of Participants With Favorable Clinical Response in the ME Analysis Set at LFU. | Trial comparisons |
| Ceftolozane/Tazobactam Arm vs Standard of Care (SOC) Arm: Number of Participants With Infection-related Mortality in the mMITT Analysis Set at LFU. | Trial comparisons |
| Ceftolozane/Tazobactam Arm vs Standard of Care (SOC) Arm: Number of Participants With Favorable Clinical Response in the ME Analysis Set at TOC | Trial comparisons |
| Ceftolozane/Tazobactam Arm vs Standard of Care (SOC) Arm: Number of Participants With Favorable Microbiological Response in the mMITT Analysis Set at LFU. | Trial comparisons |
| Ceftolozane/Tazobactam Arm vs Standard of Care (SOC) Arm: Number of Participants With Favorable Clinical Response in the MITT Analysis Set at TOC | Trial comparisons |
| Ceftolozane/Tazobactam Arm vs Standard of Care (SOC) Arm: Number of Participants With Favorable Clinical Response in the CE Analysis Set at LFU. | Trial comparisons |
| Ceftolozane/Tazobactam Arm vs Standard of Care (SOC) Arm: 30 Day All-cause Mortality in the MITT Analysis Set | Trial comparisons |
| Ceftolozane/Tazobactam Arm vs Standard of Care (SOC) Arm: Number of Participants With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV) | Trial comparisons |
1 to 10 of 26
See all 26 trial comparisonsTests0
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/NCT03485950
GET https://conductscience.org/api/trials/v1/NCT03485950/registered?page=2