A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Met… (NCT03329092) | Clinical Trial Compass
CompletedPhase 3
A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.
United States422 participantsStarted 2018-04-05
Plain-language summary
A Phase 3 comparative study to determine the efficacy, safety and tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) versus Meropenem (MER) ± Colistin (COL) for the treatment of serious infections due to Gram negative bacteria.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female from 18 years of age
✓. Provision of informed consent
✓. Confirmed diagnosis of HAP/VAP or cIAI requiring iv antibiotic treatment
✓. Female patients are authorized to participate in this clinical study if criteria concerning pregnancy avoidance stated in the protocol are met and negative pregnancy test
✓. Diagnosis of cIAI, EITHER:
✓. Surgical intervention within 24 hours (before or after) the administration of the first dose of study drug
✓. Onset symptoms \> 48h after admission to or \<7 days after discharge from an inpatient care facility
✓. New or worsening infiltrate on CXR or CT scan
Exclusion criteria
✕. APACHE II score \> 30
✕. Confirmed or suspected infection caused by Gram-negative species not expected to respond to study drug, or Gram-positive species
✕. Receipt of \>24 hr systemic antibiotic within 48h prior to randomisation (exception in case of treatment failure)
✕. History of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to aztreonam, carbapenem,monobactam or other β-lactam antibiotics, avibactam, nitroimidazoles or metronidazole, or any of the excipients of the study drugs
What they're measuring
1
Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit: Intent-To-Treat (ITT) Analysis Set
Timeframe: At TOC visit (Day 28)
2
Percentage of Participants With Clinical Cure at TOC Visit: Clinically Evaluable (CE) Analysis Set