Clinical trial • Phase III • Infectious Disease

Aztreonam | Avibactam for Sepsis

Phase III trial of Aztreonam | Avibactam for Sepsis. 16 participants.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Sepsis
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
05-12-2025
First CTIS Authorization Date
22-03-2026

Trial design

Phase III trial across 1 site in Austria.

Target Sample Size
16

Eligibility

Recruits 16 Vulnerable population selected; no details on consent or assent provided in the available documents..

Vulnerable Population
Vulnerable population selected; no details on consent or assent provided in the available documents.

Recruitment

Planned Sample Size
16
Recruitment Window Months
11

Geography

Total Number Of Sites
1
Total Number Of Participants
16

Austria

Earliest CTIS Part Ii Submission Date
09-03-2026
Latest Decision Or Authorization Date
22-03-2026
Processing Time Days
13
Number Of Sites
1
Number Of Participants
16

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Clinical Pharmacology
Contact Person Name
Markus Zeitlinger
Number Of Participants
16

Sponsor

Primary sponsor

Full Name
Medical University Of Vienna
Organisation Type
Educational Institution
Country Of Registered Address
Austria

Investigational products

Investigational Product Name
Aztreonam-Avibactam
Active Substance
Aztreonam | Avibactam
Modality
Small molecule
Combination Treatment
Yes

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