Study identifier:D4910C00009
ClinicalTrials.gov identifier:NCT02655419
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase IIa prospective, open-label, multicenter study to determine the pharmacokinetics (PK) and safety and tolerability of astreonam-avibactam (ATM-AVI) for the treatment of complicated Intra-Abdominal Infections (cIAIs) in hospitalized adults
Complicated Intra-Abdominal Infections, cIAIs
Phase 2
No
ATM-AVI, Metronidazole
All
40
Interventional
18 Years - 90 Years
Allocation: N/A
Endpoint Classification: Pharmacokinetics
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jun 2017 by AstraZeneca
AstraZeneca
Clinical Trial Centre, Cologne, CTCC, Germany, Universitätsklinikum Köln, UKK, Germany, University Medical Centre Utrecht, UMCU, the Netherlands, Servicio Andaluz de Salud, SAS, Spain, Centre Hospitalier Universitaire de Limoges, CHUL, France, Institute National de la Santé et de la Recherche Médicale, INSERM, France
Determine the PK and safety and tolerability of aztreonam-avibactam (ATM-AVI) in the treatment of hospitalized adults with cIAI
A Phase IIa prospective, open-label, multicenter study to determine the pharmacokinetics (PK) and safety and tolerability of aztreonam-avibactam (ATM-AVI) for the treatment of complicated Intra-Abdominal Infections (cIAIs) in hospitalized adults
Location
Status
Location
Lille Cedex, France, 59037
Status
Recruiting
Location
POITIERS, France, 86021
Status
Recruiting
Location
Limoges, France, 87042
Status
Recruiting
Location
Clermont-ferrand, France, 63003
Status
Recruiting
Location
Amiens Cedex 1, France, 80054
Status
Recruiting
Location
Angoulême, France, 16959
Status
Withdrawn
Location
München, Germany, 81675
Status
Recruiting
Location
Köln, Germany, 50937
Status
Recruiting
Arms | Assigned Interventions |
---|---|
Experimental: ATM-AVI ATM plus AVI treatment | Drug: ATM-AVI For patients with normal renal function or mild renal impairement: 6500mg ATM/1777mg AVI on day 1 followed by daily dose of 6000mg ATM/1640mg AVI Drug: Metronidazole Metronidazole 500mg infused over 1 hour every 8 hours Drug: ATM-AVI For patients with normal renal function or mild renal impairement: 6500mgATM/2167mg AVI on day 1 followed by daily dose of 6000mg ATM/2000mg AVI Drug: ATM-AVI For patients with moderate renal impairment: 4250mg ATM/1417mg AVI on day 1 followed by daily dose of 3000mg ATM/1000mg AVI Drug: ATM-AVI For patients with moderate renal impairement: 4250mg ATM/1162AVI on day 1 followed by daily dose of 3000mg ATM/820mg AVI |
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