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

Primary Purpose

Community Acquired Bacterial Pneumonia, Complicated Intra-Abdominal Infection

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Tigecycline

cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycoside

CAP: Ceftriaxone, plus if applicable oral clarithromycin

About this trial

This is an interventional treatment trial for Community Acquired Bacterial Pneumonia focused on measuring children, pediatry, pneumonia, intra-abdominal, infection

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A. Tigecycline

B. Ceftriaxone regimen

Arm Description

Outcomes

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

Secondary Outcome Measures

Clinical response at the IV last day of therapy (LDOT) for co-primary populations: the CE and c-mITT populations

Clinical response at follow up (FUP) visits for co-primary populations: the CE and c-mITT populations

Microbiological response at the subject and the pathogen level

Response rate by pathogen and minimum inhibitory concentration (MIC) value

Response rates for polymicrobial/monomicrobial infections, and susceptibility evaluations

Full Information

NCT ID

NCT01602874

First Posted

May 17, 2012

Last Updated

February 21, 2013

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01602874

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Withdrawn

Study Start Date

January 2011 (undefined)

Primary Completion Date

May 2014 (Anticipated)

Study Completion Date

May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Community Acquired Bacterial Pneumonia, Complicated Intra-Abdominal Infection

Keywords

children, pediatry, pneumonia, intra-abdominal, infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A. Tigecycline

Arm Type

Experimental

Arm Title

B. Ceftriaxone regimen

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Tigecycline

Other Intervention Name(s)

Tygacil

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Tigecycline

Other Intervention Name(s)

Tygacil

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycoside

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CAP: Ceftriaxone, plus if applicable oral clarithromycin

Intervention Description

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).

Primary Outcome Measure Information:

Title

Time Frame

2 to 7 weeks for cIAI and 2 to 5 weeks for CAP

Secondary Outcome Measure Information:

Title

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

Title

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

Title

Microbiological response at the subject and the pathogen level

Time Frame

5 to 9 weeks for cIAI and 5 to 7 weeks for CAP

Title

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

Title

Response rates for polymicrobial/monomicrobial infections, and susceptibility evaluations

Time Frame

5 to 9 weeks for cIAI and 5 to 7 weeks for CAP

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3074K4-3340&StudyName=Study%20Evaluating%20Tigecycline%20Versus%20Ceftriaxone%20In%20Complicated%20Intra-Abdominal%20Infections%20%26%20Community%20Acquired%20Pneumonia

Description

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

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