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

NCT00914888 | Withdrawn Phase 3 DMC

• 2 other identifiers: 3074K4-3340B1811003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Community Acquired Bacterial Pneumonia; Complicated Intra-Abdominal Infection

Keywords

children; pediatry; pneumonia; intra-abdominal; infection

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (5)

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

  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

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

• Microbiological response at the subject and the pathogen level

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

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

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

• Response rates for polymicrobial/monomicrobial infections, and susceptibility evaluations

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

Study Arms (2)

A

EXPERIMENTAL

Tigecycline

Drug: Tigecycline

B

ACTIVE COMPARATOR

Ceftriaxone regimen

Drug: cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycoside; Drug: CAP: Ceftriaxone, plus if applicable oral clarithromycin

Interventions

Tigecycline DRUG

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.

Also known as: Tygacil

A

cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycoside DRUG

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.

B

CAP: Ceftriaxone, plus if applicable oral clarithromycin DRUG

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).

B

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pneumonia; Infections

Interventions

Tigecycline; Metronidazole

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2009
• First Posted: June 5, 2009
• Study Start: January 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 7, 2012

Record last verified: 2012-06