Clinical trial • Phase III • Infectious Disease
Fosfomycin for Healthy volunteers | Critical illness
Phase III trial of Fosfomycin for Healthy volunteers | Critical illness. None/Not specified-controlled. 18 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Healthy volunteers | Critical illness
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 13-03-2024
- First CTIS Authorization Date
- 23-04-2024
Trial design
None/Not specified-controlled Phase III trial across 1 site in Austria.
- Comparator
- None/Not specified
- Target Sample Size
- 18
Recruitment
- Planned Sample Size
- 18
- Recruitment Window Months
- 129
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 18
Austria
- Earliest CTIS Part Ii Submission Date
- 08-04-2024
- Latest Decision Or Authorization Date
- 23-04-2024
- Processing Time Days
- 15
- Number Of Sites
- 1
- Number Of Participants
- 18
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Clinical Pharmacology
- Principal Investigator Name
- Markus Zeitlinger
- Principal Investigator Email
- markus.zeitlinger@meduniwien.ac.at
- Contact Person Name
- Markus Zeitlinger
- Contact Person Email
- markus.zeitlinger@meduniwien.ac.at
- Number Of Participants
- 18
Sponsor
Primary sponsor
- Full Name
- Medical University Of Vienna
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Austria
Investigational products
- Investigational Product Name
- Fosfomycin
- Active Substance
- Fosfomycin
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
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