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Doripenem vs Meropenem in Complicated Intra-Abdominal Infections
NCT00210938Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2004
- Sponsor
- Johnson & Johnson
- Modality
- Small Molecules
- Drugs
- doripenem
- Conditions
- Intra-abdominal infection (IAI)
01
Overview
Phase 3, randomised, double-blind trial of doripenem in Intra-abdominal infection (IAI) (2 arms), sponsored by Johnson & Johnson. Primary endpoint: Clinical Response Rate at Late Follow-up Visit. Started Mar 2004; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Doripenem
Doripenem IV
Comparator (Meropenem)
Meropenem IV
03
Who it enrols
Hospitalized adults with complicated intra-abdominal infections requiring surgery and antibacterial therapy.
04
Endpoints
Primary
Clinical Response Rate at Late Follow-up Visit
Secondary
Clinical Response Rate at Early Follow-up Visit
Microbiological Response Rate
Safety Assessment
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