Determine the PK and Safety and Tolerability of ATM-AVI for the Treatment of cIAIs in Hospitalized Adults (REJUVENATE)

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

May 19, 2016

Primary Completion Date

October 26, 2017

Study Completion Date

October 26, 2017

Conditions
Complicated Intra-Abdominal Infections, cIAIs
Interventions
DRUG

ATM-AVI

"Cohort 1:~(Creatinine clearance \> 50 mL/min)6500mg ATM/1777mg AVI on day 1 followed by total daily dose of 6000mg ATM/1640mg AVI~Cohorts 2 and 3:~(Creatinine clearance \> 50 mL/min) As above, or: 6500 mg ATM/2167 mg on Day 1 followed by a total daily dose of 6000 mg ATM/2000 m AVI~(Creatinine clearance 31 - 50 mL/min) 4250 mg ATM/1162 mg AVI on Day 1 followed by total daily dose 3000 mg ATM/820 mg AVI, or:~4250 mg ATM/1417 mg AVI on Day 1 followed by total daily dose 3000 mg ATM/1000 mg AVI"

DRUG

Metronidazole

Metronidazole 500mg infused over 1 hour every 8 hours

Trial Locations (11)

14004

Hospital Universitario Reina Sofia, Córdoba

23538

Universitaetsklinikum Schleswig-Holstein, Klinik fuer Infektiologie und Mikrobiologie, DZIF-CTU, Lübeck

41009

Hospital Universitario Virgen Macarena, Seville

41013

Hospital Universitario Virgen del Rocio, Seville

48903

Hospital Universitario Cruces, Barakaldo

50937

Universitaetsklinikum Koeln Innere Medizin I, Cologne

59037

University Hospital C., Lille

87042

CHU Limoges, Limoges

07010

Hospital Universitario Son Espases, Palma de Mallorca

08003

Hospital Universitari del Mar, Barcelona

08221

Hospital Universitario Mutua de Tarrasa, Terrassa

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Innovative Medicines Initiative

OTHER

lead

Pfizer

INDUSTRY

NCT02655419 - Determine the PK and Safety and Tolerability of ATM-AVI for the Treatment of cIAIs in Hospitalized Adults (REJUVENATE) | Biotech Hunter | Biotech Hunter