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Complicated Skin and Skin Structure Infections

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NCT00619710

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Skin Infection, Abscess, Cellulitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects are hospitalized males and females, aged 13 years or older, with clinical
evidence of complicated skin and skin structure bacterial infection with material
suitable for culture from 1 primary site of infections

- Within 72 hours before enrollment or at the time of enrollment, all subjects must
provide an appropriate specimen for culture and susceptibility testing

- Subjects who have been given prior antibacterial therapy within 14 days of trial entry
may be entered only if a culture is obtained showing persistence of a pathogen in
blood or at the site of infection

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

- Subjects with a known or suspected hypersensitivity to cephalosporins, penicillins, or
carbapenems

- Subjects with a history of seizure disorders or subjects currently receiving
antiepileptic medication

- Subjects with underlying infections or conditions which would interfere with
evaluation of this study

NCT00619710
Pfizer
Completed
Complicated Skin and Skin Structure Infections

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Pfizer Clinical Trials Contact Center

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[email protected]

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Complicated Skin and Skin Structure Infections
A Multicenter, Randomized, Double Blind, Comparative Trial of Intravenous MERREM (Meropenem, ICI 194,660) vs PRIMAXIN I.V. (Imipenem-cilastatin) in the Treatment of Hospitalised Subjects With Complicated Skin and Skin Structure Infections.
The purpose of this study is to demonstrate the non-inferiority of meropenem (Merrem) and imipenem in hospitalised subjects with complicated skin and skin structure infections.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Skin Infection
  • Abscess
  • Cellulitis
  • Drug: Meropenem
    Intravenous
    Other Name: Merrem
  • Drug: Imipenem-cilastatin
    Intravenous
    Other Name: Primaxin
  • Experimental: 1
    Meropenem
    Intervention: Drug: Meropenem
  • Active Comparator: 2
    Imipenem-cilastatin
    Intervention: Drug: Imipenem-cilastatin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
April 2004
December 2003   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects are hospitalized males and females, aged 13 years or older, with clinical evidence of complicated skin and skin structure bacterial infection with material suitable for culture from 1 primary site of infections
  • Within 72 hours before enrollment or at the time of enrollment, all subjects must provide an appropriate specimen for culture and susceptibility testing
  • Subjects who have been given prior antibacterial therapy within 14 days of trial entry may be entered only if a culture is obtained showing persistence of a pathogen in blood or at the site of infection

Exclusion Criteria:

  • Subjects with a known or suspected hypersensitivity to cephalosporins, penicillins, or carbapenems
  • Subjects with a history of seizure disorders or subjects currently receiving antiepileptic medication
  • Subjects with underlying infections or conditions which would interfere with evaluation of this study
Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00619710
3591IL/0079
D9211C00079
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Not Provided
Pfizer
August 2017

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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