Trial · NCT03163446
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events [Safety and Tolerability] | Through Day 7, at Test of Cure (TOC) between 56-70 days, and at Day 180 | Number and percentage of patients with treatment-emergent adverse events (TEAEs) |
| Primary | Clinical Outcome at Day 14 | Day 14 | Description of clinical outcome in the Microbiological Intent-to-Treat (mITT) population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus. |
| Primary | CF-301 Maximum Plasma Concentration (Cmax) | Pre-dose and at 0.5, 1.5, 2, 2.25, 3, 4, 8, 14, 24, and 48 hours after the start of CF-301 infusion | CF-301 plasma concentrations at specified timepoints. |
| Primary | CF-301 Area Under the Curve (AUC 0-t) | Pre-dose and at 0.5, 1.5, 2, 2.25, 3, 4, 8, 14, 24, and 48 hours after the start of CF-301 infusion | CF-301 plasma concentrations at specified time points |
| Secondary | Clinical Outcome at Day 7 | Day 7 | Description of clinical outcome in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus. |
| Secondary | Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT) | EOT between 28-42 days | Description of clinical outcome in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus. |
| Secondary | Clinical Outcome at Test of Cure (TOC) | TOC between 56-70 days | Description of clinical outcome in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus. |
| Secondary | Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration | Day 7 | Number and percentage of patients with clearance of bacteremia in the mITT population |
| Secondary | Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration | Day 14 | Number and percentage of patients with clearance of bacteremia in the mITT population |
| Secondary | Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT) | EOT between 28-42 days | Number and percentage of patients with microbiological eradication in the mITT population |
| Secondary | Microbiological Eradication at Test of Cure (TOC) | TOC between 56-70 days | Number and percentage of patients with microbiological eradication in the mITT population |
| Other | Clinical Outcome at Day 14 in MRSA Subgroup | Day 14 | Description of clinical outcome in the MRSA subgroup in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT03163446/registered