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Trial record 1 of 1 for:    NCT00914888
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Study Evaluating Tigecycline Versus Ceftriaxone In Complicated Intra-Abdominal Infections & Community Acquired Pneumonia

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ClinicalTrials.gov Identifier: NCT00914888
Recruitment Status : Withdrawn
First Posted : June 5, 2009
Last Update Posted : June 7, 2012
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE June 4, 2009
First Posted Date  ICMJE June 5, 2009
Last Update Posted Date June 7, 2012
Study Start Date  ICMJE January 2011
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2010)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2009)
The tolerability of tigecycline (safety) will be monitored by measuring vital signs, adverse event, laboratory values, ECG, and clinical signs and symptoms of the infection. [ Time Frame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP ]
Change History Complete list of historical versions of study NCT00914888 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2010)
  • 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 ]
  • 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 ]
  • Microbiological response at the subject and the pathogen level [ Time Frame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP ]
  • 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 ]
  • Response rates for polymicrobial/monomicrobial infections, and susceptibility evaluations [ Time Frame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2009)
Tigecycline vs ceftriaxone clinical efficacy based on subject outcome: last day of intravenous therapy, test of cure, follow-up. Infection clearance: subject & pathogen response. Pharmacokinetic/pharmacodynamic. Susceptibility for a range of pathogens [ Time Frame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Tigecycline Versus Ceftriaxone In Complicated Intra-Abdominal Infections & Community Acquired Pneumonia
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Community Acquired Bacterial Pneumonia
  • Complicated Intra-Abdominal Infection
Intervention  ICMJE
  • 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).

Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 5, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2009)
300
Estimated Study Completion Date  ICMJE May 2014
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada,   Oman,   Qatar,   Saudi Arabia,   United States
 
Administrative Information
NCT Number  ICMJE NCT00914888
Other Study ID Numbers  ICMJE 3074K4-3340
B1811003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP