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

Last updated on July 5, 2018

FOR MORE INFORMATION
Study Location
University of Southern California
Los Angeles, California, 90033 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Complicated Intra-abdominal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- complicated intra-abdominal infections

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00752219
Pfizer
Completed
Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections

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Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Complicated Intra-abdominal Infections
  • Drug: ceftazidime/NXL104 + metronidazole
    IV TID
  • Drug: meropenem
    IV TID
    Other Name: merrem
  • Experimental: NXL104/CAZ/MTZ
    NXL104/ceftazidime + metronidazole
    Intervention: Drug: ceftazidime/NXL104 + metronidazole
  • Active Comparator: Meropenem
    Intervention: Drug: meropenem
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
204
200
December 31, 2009
November 30, 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   France,   India,   Lebanon,   Poland,   Romania,   Russian Federation,   United States
 
 
NCT00752219
NXL-104/2002
C3591014 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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