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

Information source: Novexel Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Complicated Intra-Abdominal Infections

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

Phase: Phase 2

Status: Completed

Sponsored by: Novexel Inc

Summary

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.

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Eligibility

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

Locations and Contacts

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

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

CCB Ministry of Interior Clinical of Surgery, Sofia, Bulgaria

Multiprofile Hospital for Active Trt Emergency Med, Sofia, Bulgaria

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

Hospital Saint Joseph Marseille, Marseille, France

Hospital L'Archet II, Nice, France

CHU Nimes, Nimes, France

Medisurge Hospital Ahmedabad, Ahmedabad, India

Medisys Clinisearch India Pvt Ltd, Bangalore, India

MS Ramaiah Memorial Hospital Bangalore, Bangalore, India

Victoria Hospital Bangalore, Bangalore, India

Amrita Institute of Medical Sciences, Cochin, Cochin, India

Suyash Hospital Indore, Indore, India

SR Kalla General and Gastro Hospital, Jaipur, India

Lucknow Cancer Institute Lucknow, Lucknow, India

Al-Zahraa university Hospital, Beirut, Lebanon

Makassed General Hospital, Beirut, Lebanon

Rafik Heriri University Hospital, Beirut, Lebanon

Hammound Hospital University Medical Center, Saida, Lebanon

Labib Medical Center, Saida, Lebanon

Slaski Uniwersytet Medyczny, Katowice, Poland

Pomorskie Centrum Traumatologii, Nowe Ogrody, Poland

Katedra i Klinika Chirurgii Ogolnej, Warszawa, Poland

Samodzielny Publiczny, Warszawa, Poland

Akademicki Szpital Kliniczn, Wroclaw, Poland

Coltea Clinical Hospital, Bucharest, Romania

Floreasca Clinical Emergency Hospital, Bucharest, Romania

Fundeni Clinical Institute, Bucharest, Romania

University Emergency Hospital Bucharest, Bucharest, Romania

City Clinical Hospital # 1, Moscow, Russian Federation

City Clinical Hospital # 13, Moscow, Russian Federation

FGU National Medical Surgery, Moscow, Russian Federation

Moscow City Clinical Hospital # 31, Moscow, Russian Federation

SMO of Clinical Trials, Smolensk, Russian Federation

North-Ossetian Medical Academy, Vladikavkas, Russian Federation

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

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

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

Henry Ford Health System, Detroit, Michigan, United States

Mercury Street Medical Group, Butte, Montana, United States

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

Summa Health Systems, Akron, Ohio, United States

Remington-Daviss Inc, Columbus, Ohio, United States

ID Clinical Research Ltd, Toledo, Ohio, United States

Additional Information

Starting date: March 2009
Last updated: December 1, 2009

Page last updated: August 23, 2015

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