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

Purpose

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).

Condition	Intervention	Phase
Community Acquired Bacterial Pneumonia Complicated Intra-Abdominal Infection	Drug: Tigecycline Drug: cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycoside Drug: CAP: Ceftriaxone, plus if applicable oral clarithromycin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Metronidazole Metronidazole benzoate Metronidazole hydrochloride Ceftriaxone Ceftriaxone sodium Clarithromycin Tigecycline

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	0
Study Start Date:	January 2011
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A. Tigecycline	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
Active Comparator: B. Ceftriaxone regimen	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).

Arms

Assigned Interventions

Experimental: A. Tigecycline

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

Active Comparator: B. Ceftriaxone regimen

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).

Eligibility

Ages Eligible for Study:	8 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602874

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01602874 History of Changes
Other Study ID Numbers:	3074K4-3340, B1811003
Study First Received:	May 17, 2012
Last Updated:	February 21, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

children
pediatry
pneumonia
intra-abdominal
infection

Additional relevant MeSH terms:

Pneumonia, Bacterial
Pneumonia
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ceftriaxone
Clarithromycin
Tigecycline
Minocycline
Metronidazole

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013