Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-Abdominal Infections

Condition(s) targeted: Complicated Intra-Abdominal Infections

Intervention: ceftazidime/NXL104 + metronidazole (Drug); meropenem (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Novexel Inc

Overall contact:
Carole A Sable, MD, Phone: 484-362-2663, Email: carole.sable@novexel.com

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.

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To estimate the efficacy of NXL104/ceftazidime with respect to the clinical response in baseline microbiologically evaluable patients with cIAI at the Test of Cure (TOC) visit

Secondary outcome: evaluate the safety and tolerability profile of NXL104/ceftazidime in the treatment of cIAI in adults

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- complicated intra-abdominal infections

Exclusion Criteria:

- infections limited to hollow viscus

- ischemic bowel disease without perforation

- acute suppurative cholangitis

- acute necrotizing pancreatitis

- pts to undergo stated abdominal repair, open abdomen technique or marsupialization

- Apache II >25

Carole A Sable, MD, Phone: 484-362-2663, Email: carole.sable@novexel.com

CCB Ministry of Interior Clinical of Surgery, Sofia, Bulgaria; Recruiting

Multiprofile Hospital for Active Trt Emergency Med, Sofia, Bulgaria; Recruiting

MHAT Rousse, 2nd Clinical of Surgery, Rousse, Bulgaria; Recruiting

UMHAT Queen Joanna-ISUL, Clinical of Surgery, Sofia, Bulgaria; Recruiting

UMHAT Sveti Georgi 3rd Clinical of Surgery, Plovdiv, Bulgaria; Recruiting

CHU Nimes, Nimes, France; Recruiting

Hospital Saint Joseph Marseille, Marseille, France; Recruiting

Hospital L'Archet II, Nice, France; Recruiting

SR Kalla General and Gastro Hospital, Jaipur, India; Recruiting

Amrita Institute of Medical Sciences, Cochin, Cochin, India; Recruiting

MS Ramaiah Memorial Hospital Bangalore, Bangalore, India; Recruiting

Suyash Hospital Indore, Indore, India; Recruiting

Victoria Hospital Bangalore, Bangalore, India; Recruiting

Medisurge Hospital Ahmedabad, Ahmedabad, India; Recruiting

Lucknow Cancer Institute Lucknow, Lucknow, India; Recruiting

Medisys Clinisearch India Pvt Ltd, Bangalore, India; Recruiting

Hammound Hospital University Medical Center, Saida, Lebanon; Recruiting

Rafik Heriri University Hospital, Beirut, Lebanon; Recruiting

Makassed General Hospital, Beirut, Lebanon; Recruiting

Labib Medical Center, Saida, Lebanon; Recruiting

Al-Zahraa university Hospital, Beirut, Lebanon; Recruiting

Akademicki Szpital Kliniczn, Wroclaw, Poland; Recruiting

Katedra i Klinika Chirurgii Ogolnej, Warszawa, Poland; Recruiting

Pomorskie Centrum Traumatologii, Nowe Ogrody, Poland; Recruiting

Samodzielny Publiczny, Warszawa, Poland; Recruiting

Slaski Uniwersytet Medyczny, Katowice, Poland; Recruiting

University Emergency Hospital Bucharest, Bucharest, Romania; Recruiting

Coltea Clinical Hospital, Bucharest, Romania; Recruiting

Fundeni Clinical Institute, Bucharest, Romania; Recruiting

Floreasca Clinical Emergency Hospital, Bucharest, Romania; Recruiting

City Clinical Hospital # 13, Moscow, Russian Federation; Recruiting

FGU National Medical Surgery, Moscow, Russian Federation; Recruiting

North-Ossetian Medical Academy, Vladikavkas, Russian Federation; Recruiting

SMO of Clinical Trials, Smolensk, Russian Federation; Recruiting

City Clinical Hospital # 1, Moscow, Russian Federation; Recruiting

Moscow City Clinical Hospital # 31, Moscow, Russian Federation; Recruiting

Michael S. Somero Research Division, Palm Springs, California, United States; Recruiting

University of Southern California, Los Angeles, California 90033, United States; Recruiting

Cedars-Sinai Medical Center Dept of Surgery, Los Angeles, California, United States; Recruiting

Henry Ford Health System, Detroit, Michigan, United States; Recruiting

Mercury Street Medical Group, Butte, Montana, United States; Recruiting

South Jersey Infectious Disease, Somers Point, New Jersey, United States; Recruiting

Remington-Daviss Inc, Columbus, Ohio, United States; Recruiting

ID Clinical Research Ltd, Toledo, Ohio, United States; Recruiting

Summa Health Systems, Akron, Ohio, United States; Recruiting

Starting date: March 2009
Ending date: November 2009
Last updated: June 17, 2009