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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01602874
First received: May 17, 2012
Last updated: February 21, 2013
Last verified: February 2013

May 17, 2012
February 21, 2013
January 2011
May 2014   (final data collection date for primary outcome measure)
Clinical efficacy response (cure, failure, or indeterminate) at the test of cure (TOC) visit for 2 co-primary populations: the clinically evaluable (CE) and clinical modified Intent-to-Treat (c-mITT) populations [ Time Frame: 2 to 7 weeks for cIAI and 2 to 5 weeks for CAP ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01602874 on ClinicalTrials.gov Archive Site
  • Clinical response at the IV last day of therapy (LDOT) for co-primary populations: the CE and c-mITT populations [ Time Frame: 5 days to 4 weeks for cIAI and 5 days to 2 weeks for CAP ] [ Designated as safety issue: No ]
  • Clinical response at follow up (FUP) visits for co-primary populations: the CE and c-mITT populations [ Time Frame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP ] [ Designated as safety issue: No ]
  • Microbiological response at the subject and the pathogen level [ Time Frame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP ] [ Designated as safety issue: No ]
  • Response rate by pathogen and minimum inhibitory concentration (MIC) value [ Time Frame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP ] [ Designated as safety issue: No ]
  • Response rates for polymicrobial/monomicrobial infections, and susceptibility evaluations [ Time Frame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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).
Both
8 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01602874
3074K4-3340, B1811003
Yes
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