Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections
NCT ID: NCT00752219
Last Updated: 2018-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
204 participants
INTERVENTIONAL
2009-03-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NXL104/CAZ/MTZ
NXL104/ceftazidime + metronidazole
ceftazidime/NXL104 + metronidazole
IV TID
Meropenem
meropenem
IV TID
Interventions
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ceftazidime/NXL104 + metronidazole
IV TID
meropenem
IV TID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center Dept of Surgery
Los Angeles, California, 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
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
Nîmes, , 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
Suyash Hospital Indore
Indore, , India
SR Kalla General and Gastro Hospital
Jaipur, , India
Amrita Institute of Medical Sciences, Cochin
Kochi, , 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
Warsaw, , Poland
Samodzielny Publiczny
Warsaw, , 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 # 13
Moscow, , Russia
City Clinical Hospital # 1
Moscow, , Russia
FGU National Medical Surgery
Moscow, , Russia
Moscow City Clinical Hospital # 31
Moscow, , Russia
SMO of Clinical Trials
Smolensk, , Russia
North-Ossetian Medical Academy
Vladikavkas, , Russia
Countries
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References
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Nichols WW, Stone GG, Newell P, Broadhurst H, Wardman A, MacPherson M, Yates K, Riccobene T, Critchley IA, Das S. Ceftazidime-Avibactam Susceptibility Breakpoints against Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2018 Oct 24;62(11):e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.
Other Identifiers
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C3591014
Identifier Type: OTHER
Identifier Source: secondary_id
NXL-104/2002
Identifier Type: -
Identifier Source: org_study_id
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