Trial · NCT04983901
PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN
NCT04983901, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2024-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN. Trials, record NCT04983901. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04983901
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN
- NCT number
- NCT04983901
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- Interventions
- Imipenem/Cilastatin/Relebactam, Cefepime, Meropenem, Piperacillin-Tazobactam, Vancomycin, Daptomycin, Linezolid
- First posted
- 2021-07-30
- Last updated
- 2026-04-06
- Results first posted
- 2024-03-12
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Outcome in the MITT Analysis Set at EOIV. | Within 72 hours after administration of the last dose of inpatient IV study drug. | The primary efficacy outcome is favorable clinical response of the patients in the MITT (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 | Clinical Outcome in the 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 | Clinical Outcome in the 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 | Clinical Outcome 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: Clinical cure, Clinical failure, and Indeterminate. |
| Secondary | Clinical Outcome in the MITT 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 MITT (Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate. |
| Secondary | Clinical Outcome in the mMITT 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 mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate. |
| Secondary | Clinical Outcome in the mMITT Analysis Set at LFU. | Pateints in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set | 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: Clinical cure, Clinical failure, and Indeterminate. |
| Secondary | Clinical Outcome 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: Clinical cure, Clinical failure, and Indeterminate. |
| Secondary | Clinical Outcome 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: Clinical cure, Clinical failure, and Indeterminate. |
| Secondary | Clinical Outcome 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 | Clinical Outcome in the MITT Analysis Set at EOIV. | Within 72 hours after administration of the last dose of inpatient IV study drug. | Patients in MITT (Modified Intent-To-Treat) Analysis Set The MITT Analysis Set will be a subset of the ITT Analysis Set and will include all randomized patients who received any amount of inpatient IV study drug and meet minimal disease criteria (Inclusion Criterion 3). Patients will be analyzed according to randomized treatment group, regardless of treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Outcome in the 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 The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Outcome in the 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 - A subset of the MITT Analysis Set including patients with the following conditions:~Received \>=48 hrs of IV study drug to be considered an evaluable clinical failure, unless deemed a clinical failure based on a treatment-limiting AE Received \>=48 hrs of IV gram negative coverage to be considered an evaluable clinical cure Had clinical outcome assessment at TOC (other than indeterminate) or assessed as clinical failure at EOIV or TOC | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Outcome in the MITT Analysis Set at TOC. | 21 to 28 days after the start of inpatient IV study drug. | Pateints in MITT (Modified Intent-To-Treat) Analysis Set The MITT Analysis Set will be a subset of the ITT Analysis Set and will include all randomized patients who received any amount of inpatient IV study drug and meet minimal disease criteria (Inclusion Criterion 3). Patients will be analyzed according to randomized treatment group, regardless of treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Outcome in the MITT Analysis Set at LFU. | 35 to 42 days after the start of inpatient IV study drug. | Pateints in MITT (Modified Intent-To-Treat) Analysis Set The MITT Analysis Set will be a subset of the ITT Analysis Set and will include all randomized patients who received any amount of inpatient IV study drug and meet minimal disease criteria (Inclusion Criterion 3). Patients will be analyzed according to randomized treatment group, regardless of treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Outcome in the mMITT Analysis Set at TOC. | 21 to 28 days after the start of inpatient IV study drug. | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Outcome in the mMITT Analysis Set at LFU. | Pateints in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Outcome 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 - A subset of the MITT Analysis Set including patients with the following conditions:~Received \>=48 hrs of IV study drug to be considered an evaluable clinical failure, unless deemed a clinical failure based on a treatment-limiting AE Received \>=48 hrs of IV gram negative coverage to be considered an evaluable clinical cure Had clinical outcome assessment at TOC (other than indeterminate) or assessed as clinical failure at EOIV or TOC | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Outcome 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 - A subset of the MITT Analysis Set including patients with the following conditions:~Received \>=48 hrs of IV study drug to be considered an evaluable clinical failure, unless deemed a clinical failure based on a treatment-limiting AE Received \>=48 hrs of IV gram negative coverage to be considered an evaluable clinical cure Had clinical outcome assessment at TOC (other than indeterminate) or assessed as clinical failure at EOIV or TOC | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Outcome in the ME Analysis Set at EOIV. | Within 72 hours after administration of the last dose of inpatient IV study drug. | Patients in ME (Microbiologically Evaluable) Analysis Set The ME Analysis Set will include patients who meet the criteria for both the CE and mMITT analysis sets. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group104
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Outcome in the MITT Analysis Set at EOIV. | Imipenem-Relebactam Arm | Favorable clinical resposne | 44 | Participants | |
| Clinical Outcome in the MITT Analysis Set at EOIV. | Standard of Care (SOC) Arm | Favorable clinical resposne | 37 | Participants | |
| Clinical Outcome in the MITT Analysis Set at EOIV. | Imipenem-Relebactam Arm | Clinical failure | 5 | Participants | |
| Clinical Outcome in the MITT Analysis Set at EOIV. | Standard of Care (SOC) Arm | Clinical failure | 12 | Participants | |
| Clinical Outcome in the MITT Analysis Set at EOIV. | Imipenem-Relebactam Arm | Indeterminate | 0 | Participants | |
| Clinical Outcome in the MITT Analysis Set at EOIV. | Standard of Care (SOC) Arm | Indeterminate | 1 | Participants | |
| Clinical Outcome in the mMITT Analysis Set at EOIV. | Imipenem-Relebactam Arm | Favorable clinical resposne | 6 | Participants | |
| Clinical Outcome in the mMITT Analysis Set at EOIV. | Standard of Care (SOC) Arm | Favorable clinical resposne | 8 | Participants | |
| Clinical Outcome in the mMITT Analysis Set at EOIV. | Imipenem-Relebactam Arm | Clinical failure | 1 | Participants | |
| Clinical Outcome in the mMITT Analysis Set at EOIV. | Standard of Care (SOC) Arm | Clinical failure | 3 | Participants |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Imipenem-Relebactam Arm | 50 | |
| Overall Study | STARTED | Standard of Care (SOC) Arm | 50 | |
| Overall Study | COMPLETED | Imipenem-Relebactam Arm | 44 | |
| Overall Study | COMPLETED | Standard of Care (SOC) Arm | 44 | |
| Overall Study | NOT COMPLETED | Imipenem-Relebactam Arm | 6 | |
| Overall Study | NOT COMPLETED | Standard of Care (SOC) Arm | 6 |
Source ClinicalTrials.gov
Adverse events152
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 | Diarrhea | Gastrointestinal disorders | Imipenem-Relebactam Arm | 1 | 49 | |
| other | Diarrhea | Gastrointestinal disorders | Group II (Cefepime, Meropenem, Piperacillin/Tazobactam) | 0 | 50 | |
| other | Vomiting | Gastrointestinal disorders | Imipenem-Relebactam Arm | 2 | 49 | |
| other | Vomiting | Gastrointestinal disorders | Group II (Cefepime, Meropenem, Piperacillin/Tazobactam) | 0 | 50 | |
| other | Allergic Reaction | Immune system disorders | Imipenem-Relebactam Arm | 1 | 49 | |
| other | Allergic Reaction | Immune system disorders | Group II (Cefepime, Meropenem, Piperacillin/Tazobactam) | 1 | 50 | |
| other | Infusion related reaction | Injury, poisoning and procedural complications | Imipenem-Relebactam Arm | 1 | 49 | |
| other | Infusion related reaction | Injury, poisoning and procedural complications | Group II (Cefepime, Meropenem, Piperacillin/Tazobactam) | 0 | 50 | |
| other | Alanine aminotransferase increased | Investigations | Imipenem-Relebactam Arm | 0 | 49 | |
| other | Alanine aminotransferase increased | Investigations | Group II (Cefepime, Meropenem, Piperacillin/Tazobactam) | 4 | 50 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imipenem-Relebactam Arm | 1 | 49 |
| Total, all-cause mortality | Group II (Cefepime, Meropenem, Piperacillin/Tazobactam) | 4 | 50 |
| Total, other adverse events | Imipenem-Relebactam Arm | 4 | 49 |
| Total, other adverse events | Group II (Cefepime, Meropenem, Piperacillin/Tazobactam) | 7 | 50 |
| Total, serious adverse events | Imipenem-Relebactam Arm | 30 | 49 |
| Total, serious adverse events | Group II (Cefepime, Meropenem, Piperacillin/Tazobactam) | 29 | 50 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39456544 | DERIVED |
Source PubMed
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Imipenem-Relebactam Arm vs Standard of Care (SOC) Arm: 30-Day All-cause Mortality in the mMITT Analysis Set. | Trial comparisons |
| Imipenem-Relebactam Arm vs Standard of Care (SOC) Arm: Infection-related Mortality in the MITT Analysis Set at LFU. | Trial comparisons |
| Imipenem-Relebactam Arm vs Standard of Care (SOC) Arm: Infection-related Mortality in the MITT Analysis Set at TOC. | Trial comparisons |
| Imipenem-Relebactam Arm vs Group II (Cefepime, Meropenem, Piperacillin/Tazobactam): deaths from any cause | Trial comparisons |
| Imipenem-Relebactam Arm vs Standard of Care (SOC) Arm: Infection-related Mortality in the mMITT Analysis Set at LFU. | Trial comparisons |
| Imipenem-Relebactam Arm vs Standard of Care (SOC) Arm: Infection-related Mortality in the mMITT Analysis Set at TOC. | Trial comparisons |
| Imipenem-Relebactam Arm vs Standard of Care (SOC) Arm: 30-Day All-cause Mortality in the MITT Analysis Set. | Trial comparisons |
| Imipenem-Relebactam Arm vs Group II (Cefepime, Meropenem, Piperacillin/Tazobactam): 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/NCT04983901
GET https://conductscience.org/api/trials/v1/NCT04983901/registered?page=2