Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age
NCT00488345
ABOUT THIS STUDY
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- Male or female patients aged 8 to 11 years, inclusive, willing and able to complete all activities required for the study
- Have a diagnosis of a serious infection (cIAI, cSSSI or CAP) requiring hospitalization and administration of IV antibiotic therapy during greater than or equal to 5 days
- Other inclusion criteria apply.
- Patients with any concomitant condition or taking any concomitant medication that, in
the opinion of the investigator, could preclude an evaluation of safety or efficacy
responses or make it unlikely that the anticipated course of therapy or follow-up
assessment will be completed (e.g., life expectancy < 30 days).
- Pregnant or breastfeeding female patients and female patients of childbearing
potential who are unable or unwilling to take adequate contraceptive precautions.
- Previous participation in this clinical trial.
- Receipt of any investigational drugs or devices (defined as lacking any regulatory
agency's approval within 4 weeks before administration of the first dose of
tigecycline).
- Endocarditis; presence of an artificial heart valve or infected device that will not
be removed.
- Known or suspected hypersensitivity to tigecycline or other compounds related to this
class of antibacterial agents (i.e., tetracyclines).
- Known or suspected P. aeruginosa infection.
- Patients receiving immunosuppressive therapy that, in the opinion of the investigator,
would decrease the patient's ability to eradicate the infection, including the use of
high-dose corticosteroid.
- Receipt of an organ or bone marrow transplant.
- Presence of any of the following laboratory findings: Neutropenia (absolute neutrophil
count < 1 × 109/L [< 1000/mm3]) , AST or ALT > 10 × the ULN or bilirubin > 3 × ULN,
unless isolated hyperbilirubinemia is directly related to the acute process (for
patients with cIAI).
- Patients with any of the following conditions:
- Cystic fibrosis.
- Active tuberculosis.
- Congenital immunodeficiency.
- Meningitis.
- Septic shock.
- Osteomyelitis (suspected or evident).
- Refractory shock syndrome in which hemodynamic parameters cannot be maintained
despite adequate supportive therapy.
- Confirmed malignancy with patient receiving an active course of chemotherapeutic
agents.
- Known or suspected infection with human immunodeficiency virus (HIV) or positive
test result for HIV antibody.
- Known or suspected concomitant bacterial or parasitic infection requiring
systemic treatment.
- cSSSI patients, the presence of decubitus ulcers, necrotizing fasciitis, gas gangrene,
or skeletal infection;
- CAP patients who have been hospitalized within 14 days before the onset of symptoms;
- CAP Patients: Presence of any of the following for patients with pneumonia:
- Postobstructive pneumonia.
- Pulmonary abscess.
- Empyema.
- Known or suspected pulmonary infection with Pneumocystis carinii.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age | |||
Official Title ICMJE | A Multicenter, Open-Label, Ascending Multiple-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age With Selected Serious Infections | |||
Brief 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). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE | Drug: Tygacil | |||
Study Arms ICMJE |
| |||
Publications * | Purdy J, Jouve S, Yan JL, Balter I, Dartois N, Cooper CA, Korth-Bradley J. Pharmacokinetics and safety profile of tigecycline in children aged 8 to 11 years with selected serious infections: a multicenter, open-label, ascending-dose study. Clin Ther. 2012 Feb;34(2):496-507.e1. doi: 10.1016/j.clinthera.2011.12.010. Epub 2012 Jan 16. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 59 | |||
Original Enrollment ICMJE | 72 | |||
Actual Study Completion Date ICMJE | September 2009 | |||
Actual Primary Completion Date | September 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion criteria
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 8 Years to 11 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Mexico, South Africa, Taiwan, Ukraine, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00488345 | |||
Other Study ID Numbers ICMJE | 3074K4-2207 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | September 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |