Trial · NCT04983901
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| 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. |
| Secondary | Clinical Outcome in the ME 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 ME (Microbiologically 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 ME 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 ME (Microbiologically Evaluable) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate. |
| Secondary | Microbiological 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 microbiological response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at end of inpatient intravenous therapy (EOIV). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate. |
| Secondary | Microbiological 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 microbiological response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate. |
| Secondary | Microbiological Outcome in the mMITT Analysis Set at LFU. | 35 to 42 days after the start of inpatient IV study drug. | The secondary efficacy outcome is favorable microbiological response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate. |
| Secondary | Microbiological 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 microbiological response of the patients in the ME (Microbiologically Evaluable) Analysis Set at end of inpatient intravenous therapy (EOIV). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate. |
| Secondary | Microbiological Outcome in the ME Analysis Set at TOC. | 21 to 28 days after the start of inpatient IV study drug. | The secondary efficacy outcome is favorable microbiological response of the patients in the ME (Microbiologically Evaluable) Analysis Set at test-of-cure (TOC). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate. |
| Secondary | Microbiological Outcome in the ME Analysis Set at LFU. | 35 to 42 days after the start of inpatient IV study drug. | The secondary efficacy outcome is favorable microbiological response of the participants in the ME (Microbiologically Evaluable) Analysis Set at late follow-up (LFU). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate. |
| Secondary | Infection-related Mortality in the MITT Analysis Set at TOC. | 21 to 28 days after the start of inpatient IV study drug. | The secondary efficacy outcome is infection-related mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). |
| Secondary | Infection-related Mortality in the MITT Analysis Set at LFU. | 35 to 42 days after the start of inpatient IV study drug. | The secondary efficacy outcome is infection-related mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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