Trial · NCT03485950
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 | 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. |
| Secondary | Number of Participants With Favorable Clinical Response 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: Favorable clinical response, Clinical failure, and Indeterminate. |
| Secondary | Number of Participants With Favorable Clinical Response 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: Favorable clinical response, Clinical failure, and Indeterminate. |
| Secondary | Number of Participants With Favorable Microbiological Response 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 clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
| Secondary | Favorable Microbiological Response 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 clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
| Secondary | Number of Participants With Favorable Microbiological Response 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 clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
| Secondary | Number of Participants With Favorable Microbiological 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. |
| Secondary | Number of Participants With Favorable Microbiological Response 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 clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
| Secondary | Number of Participants With Favorable Microbiological Response 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 patients in the ME (Microbiologically 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 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 | Number of Participants With 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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