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

• ClinicalTrials.gov Identifier: NCT01602874
• Recruitment Status: Withdrawn
• First Posted: May 21, 2012
• Last Update Posted: February 22, 2013
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: May 17, 2012
• First Posted Date: May 21, 2012
• Last Update Posted Date: February 22, 2013
• Study Start Date: January 2011
• Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 17, 2012): 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: Same as current

Current Secondary Outcome Measures (submitted: May 17, 2012)

• 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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Evaluating Tigecycline Versus Ceftriaxone In Complicated Intra-Abdominal Infections & Community Acquired Pneumonia
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Community Acquired Bacterial Pneumonia
• Complicated Intra-Abdominal Infection

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: February 21, 2013): 0
• Original Estimated Enrollment (submitted: May 17, 2012): 300
• Estimated Study Completion Date: May 2014
• Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 8 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01602874
• Other Study ID Numbers: 3074K4-3340; B1811003
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: February 2013