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A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection

Last updated on April 11, 2018

FOR MORE INFORMATION
Study Location
Anqing City Hospital
Anqing, Anhui, 246003 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Intra-abdominal Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Hospitalized male or female subjects, at least 18 year of age.

- Complicated intra-abdominal infection is present at most under two weeks duration.

- Minimal clinical criteria at the time of intra-abdominal infection diagnosis or highly
suspected intra-abdominal infection.

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

- Anticipated length of antibiotic therapy less than 5 days or the likelihood that the
subject will not complete the course of treatment.

- Intra-abdominal infection known to be caused by 1 or more bacterial pathogens not
susceptible to both of the study drugs.

- Had accepted non-study antibiotics more than 24 hr within 72 hrs before enrollment
except for subjects declared prior failures.

NCT01721408
Pfizer
Completed
A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection

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A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection
A Multicenter, Double-blind, Randomized, Comparison Study Of The Efficacy And Safety Of Tigecycline To Imipenem/Cilastatin To Treat Complicated Intra-abdominal Infections In Hospitalized Subjects.
This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin in hospitalized patients with a complicated intra-abdominal infection.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Intra-abdominal Infection
  • Drug: Tigecycline
    every 12 hours (an initial intravenous dose of 100 mg followed by 50 mg twice a day approximately every 12 hours) and placebo intravenous doses every 12 hours beginning 6 hours after the initial intravenous dose of tigecycline for at least for 5 days and up to 14 days.
  • Drug: Imipenem/cilastatin
    every 6 hours intravenously, and the imipenem/cilastatin will be dosed by 500mg/500mg for the subjects with creatinine clearance equal or above 71ml/min/1.73m2 or dose will be adjusted by Schedule of Study Drug Administration for Subjects with Renal Impairment.
  • Experimental: Group A
    Intervention: Drug: Tigecycline
  • Active Comparator: Group B
    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
470
October 2015
October 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hospitalized male or female subjects, at least 18 year of age.
  • Complicated intra-abdominal infection is present at most under two weeks duration.
  • Minimal clinical criteria at the time of intra-abdominal infection diagnosis or highly suspected intra-abdominal infection.

Exclusion Criteria:

  • Anticipated length of antibiotic therapy less than 5 days or the likelihood that the subject will not complete the course of treatment.
  • Intra-abdominal infection known to be caused by 1 or more bacterial pathogens not susceptible to both of the study drugs.
  • Had accepted non-study antibiotics more than 24 hr within 72 hrs before enrollment except for subjects declared prior failures.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01721408
B1811185
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2016

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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