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Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age

NCT00488345 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2012-10-24

Study results available
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Summary

To determine the pharmacokinetic profile and to evaluate the safety and tolerability of ascending multiple doses of tigecycline in patients aged 8 to 11 years with selected serious infections; complicated intra-abdominal infections (cIAI), complicated skin and skin structure infections (cSSSI), or community-acquired pneumonia (CAP).

Conditions

  • Bacterial Infections
  • Intra-Abdominal Infection
  • Pneumonia, Bacterial
  • Skin Diseases, Bacterial
  • Skin Diseases, Infectious

Interventions

DRUG

Tygacil

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States
  • Belgium
  • Mexico
  • South Africa
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00488345 on ClinicalTrials.gov