Ventilator-Associated Pneumonia
Conditions
Brief summary
Analysis of TP-122A arm with SoC versus SoC alone, and individual analysis per treatment arm of the following assessments: Adverse Events (AEs), Clinical laboratory parameters, Vital signs, Eletrocardiogram (ECG)
Detailed description
Proportion of subjects achieving “Clinical Cure” (CR), Time to achieve “Clinical Cure”., Proportion of subjects achieving Microbiological Response (MR) of “Eradication” or “Presumed Eradication” of TP-122A target bacteria, Time to achieve MR “Eradication” or “Presumed Eradication”., Number of days of antibiotic usage., Number of days with MV., Number of days to discharge from ICU., Overall Survival: all-cause mortality, at FUp2.
Interventions
DRUGTP-122
Sponsors
Technophage Investigacao E Desenvolvimento Em Biotecnologia S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis of TP-122A arm with SoC versus SoC alone, and individual analysis per treatment arm of the following assessments: Adverse Events (AEs), Clinical laboratory parameters, Vital signs, Eletrocardiogram (ECG) | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving “Clinical Cure” (CR), Time to achieve “Clinical Cure”., Proportion of subjects achieving Microbiological Response (MR) of “Eradication” or “Presumed Eradication” of TP-122A target bacteria, Time to achieve MR “Eradication” or “Presumed Eradication”., Number of days of antibiotic usage., Number of days with MV., Number of days to discharge from ICU., Overall Survival: all-cause mortality, at FUp2. | — |
Countries
Netherlands, Portugal
Outcome results
None listed