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Study Evaluating Tigecycline Versus Ceftriaxone In Complicated Intra-Abdominal Infections & Community Acquired Pneumonia

Last updated on May 10, 2018

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Community Acquired Bacterial Pneumonia, Complicated Intra-Abdominal Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
8-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subjects 8 to 17 years old. Children with bone maturation less than 8
years old should be enrolled with caution due to potential risk of tooth
discoloration.

- Have a diagnosis of a serious infection (complicated intra-abdominal infections [cIAI]
or community acquired pneumonia [CAP] as applicable) requiring hospitalization and
administration of IV antibiotic therapy.

- Criteria related indication (cIAI or CAP - as applicable), e.g., sign of systemic
infection, signs and symptom.

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

- Subject with any concomitant illness/condition that, in the investigator's judgment,
will substantially increase the risk associated with the subject's participation in
and/or completion of the study, or could preclude the evaluation of the subject's
response (e.g., life expectancy

NCT01602874
Pfizer
Withdrawn
Study Evaluating Tigecycline Versus Ceftriaxone In Complicated Intra-Abdominal Infections & Community Acquired Pneumonia

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Study Evaluating Tigecycline Versus Ceftriaxone In Complicated Intra-Abdominal Infections & Community Acquired Pneumonia
Multicenter, Randomized, And Double-Blind Study To Evaluate The Safety Of Tigecycline Versus A Ceftriaxone Regimen In The Treatment Of Complicated Intra-Abdominal Infections And Community-Acquired Pneumonia In Subjects Of 8-17 Years
The main purpose of this study is to compare the safety of tigecycline versus a ceftriaxone regimen in pediatric subjects (aged 8 to 17 years) with complicated intra-abdominal infections (cIAI) and community acquired pneumonia (CAP).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Community Acquired Bacterial Pneumonia
  • Complicated Intra-Abdominal Infection
  • Drug: Tigecycline

    Subject with cIAI:

    Dosing information for subjects 8 to 11 years old is currently under investigation and will be determined later. Subjects 12 to 17 years old will receive tigecycline 50 mg IV every 12 hours, metronidazole placebo IV will be administered every 8 hours. In addition, at the discretion of the investigator, an aminoglycoside placebo IV may also be administered.

    Other Name: Tygacil
  • Drug: Tigecycline

    Subject with CAP:

    IV therapy period: Dosing information for subjects 8 to 11 years old is currently under investigation and will be determined later. Subjects 12 to 17 years old will receive tigecycline 50 mg IV every 12h. At the discretion of the investigator oral clarithromycin placebo may be given every 12h.

    Oral therapy period: If oral switch criteria are met, on or after Day 4 amoxicillin/clavulanate may be prescribed (40 mg/kg per day divided into 3 equal doses, maximum of 500 mg/dose to subjects weighing less than 40 kg and 500 mg every 8h to subjects weighing 40 kg or greater). In addition, if oral clarithromycin or placebo had been given during the IV period, oral clarithromycin may be given every 12h (7.5 mg/kg, maximum dose 500 mg for subjects 8 to 11 years old, 500 mg for subjects 12 to 17 years old).

    Other Name: Tygacil
  • Drug: cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycoside

    Subject with cIAI:

    Subjects will receive ceftriaxone 35 mg/kg (maximum of 1 g/dose) IV every 12 hours, metronidazole 10 mg/kg (maximum of 1 g/dose) IV will be administered every 8 hours.

    In addition, at the discretion of the investigator, an aminoglycoside IV (adjusted dose if necessary) may also be given.

  • Drug: CAP: Ceftriaxone, plus if applicable oral clarithromycin

    Subject with CAP:

    IV therapy period: Subjects will receive ceftriaxone 35 mg/kg (maximum of 1 g/dose) IV every 12h. At the discretion of the investigator, oral clarithromycin may be given every 12h (7.5 mg/kg, maximum dose 500 mg for subjects 8 to 11 years old, 500 mg for subjects 12 to 17 years old).

    Oral therapy period: If oral switch criteria are met, on or after Day 4 amoxicillin/clavulanate may be prescribed (40 mg/kg per day divided into 3 equal doses, maximum of 500 mg/dose to subjects weighing less than 40 kg and 500 mg every 8h to subjects weighing 40 kg or greater). In addition, if oral clarithromycin or placebo had been given during the IV period, oral clarithromycin may be given every 12h (7.5 mg/kg, maximum dose 500 mg for subjects 8 to 11 years old, 500 mg for subjects 12 to 17 years old).

  • Experimental: A. Tigecycline
    Interventions:
    • Drug: Tigecycline
    • Drug: Tigecycline
  • Active Comparator: B. Ceftriaxone regimen
    Interventions:
    • Drug: cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycoside
    • Drug: CAP: Ceftriaxone, plus if applicable oral clarithromycin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2014
May 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects 8 to 17 years old. Children with bone maturation less than 8 years old should be enrolled with caution due to potential risk of tooth discoloration.
  • Have a diagnosis of a serious infection (complicated intra-abdominal infections [cIAI] or community acquired pneumonia [CAP] as applicable) requiring hospitalization and administration of IV antibiotic therapy.
  • Criteria related indication (cIAI or CAP - as applicable), e.g., sign of systemic infection, signs and symptom.

Exclusion Criteria:

  • Subject with any concomitant illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and/or completion of the study, or could preclude the evaluation of the subject's response (e.g., life expectancy <30 days).
Sexes Eligible for Study: All
8 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01602874
3074K4-3340
B1811003
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

ICMJE     Data element required by the

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

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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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