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Official Title

The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated intra-abdominal infections as compared to a comparator group.

Prospective Multicenter Doubleblind Randomized Study of NXL104/ceftazidime + metronidazole vs. meropenem in treatment of complicated intra-abdominal infections

South Jersey Infectious Disease

Remington-Daviss Inc

ID Clinical Research Ltd

Mercury Street Medical Group

Michael S. Somero Research Division

Summa Health Systems

Hammound Hospital University Medical Center

Rafik Heriri University Hospital

Makassed General Hospital

SR Kalla General and Gastro Hospital

University of Southern California

Cedars-Sinai Medical Center Dept of Surgery

Henry Ford Health System

CCB Ministry of Interior Clinical of Surgery

Multiprofile Hospital for Active Trt Emergency Med

MHAT Rousse, 2nd Clinical of Surgery

UMHAT Queen Joanna-ISUL, Clinical of Surgery

UMHAT Sveti Georgi 3rd Clinical of Surgery

CHU Nimes

Hospital Saint Joseph Marseille

Hospital L'Archet II

Akademicki Szpital Kliniczn

Katedra i Klinika Chirurgii Ogolnej

Pomorskie Centrum Traumatologii

Samodzielny Publiczny

Slaski Uniwersytet Medyczny

University Emergency Hospital Bucharest

Coltea Clinical Hospital

Fundeni Clinical Institute

Floreasca Clinical Emergency Hospital

City Clinical Hospital # 13

FGU National Medical Surgery

North-Ossetian Medical Academy

SMO of Clinical Trials

City Clinical Hospital # 1

Moscow City Clinical Hospital # 31

Amrita Institute of Medical Sciences, Cochin

MS Ramaiah Memorial Hospital Bangalore

Suyash Hospital Indore

Victoria Hospital Bangalore

Medisurge Hospital Ahmedabad

Lucknow Cancer Institute Lucknow

Medisys Clinisearch India Pvt Ltd

Labib Medical Center

Al-Zahraa university Hospital

A Prospective, Multicenter, Double-blind, Randomized, Comparative Study to estimate the safety, tolerability and efficacy of NXL104/ceftazidime plus metronidazole vs. meropenem in the treatment of complicated intra-abdominal infections in hospitalized adults

Cure: complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention is necessary.

Favorable: eradication (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication (absence of material to culture in a patient who had responded clinically to treatment)

Arms	Assigned Interventions
Experimental: NXL104/CAZ/MTZ NXL104/ceftazidime + metronidazole	Drug: ceftazidime/NXL104 + metronidazole IV TID
Active Comparator: Meropenem	Drug: meropenem IV TID Other Name: merrem

Prospective Multicenter Doubleblind Randomized Study of NXL104/ceftazidime + metronidazole vs. meropenem in treatment of complicated intra-abdominal infections

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South Jersey Infectious Disease

Remington-Daviss Inc

ID Clinical Research Ltd

Mercury Street Medical Group

Michael S. Somero Research Division

Summa Health Systems

Hammound Hospital University Medical Center

Rafik Heriri University Hospital

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=219&filename=CSP-NXL104-2002.pdf

CSP-NXL104-2002.pdf

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