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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Long Beach, California, 90806 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Infections, Intra-Abdominal Infection, Bacterial Pneumonia, Bacterial Skin Diseases, Infectious Skin Diseases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
8-11 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

- 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 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.

NCT00488345
Pfizer
Completed
Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age

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Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age
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
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).
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Bacterial Infections
  • Intra-Abdominal Infection
  • Pneumonia, Bacterial
  • Skin Diseases, Bacterial
  • Skin Diseases, Infectious
Drug: Tygacil
  • Experimental: A
    0.75 mg/kg (up to a maximum dose of 50 mg for each dose) of tigecycline every 12 hours infused over approximately 30 minutes. Escalation to next dose cohort will occur only after safety and tolerability at preceding dose have been established by sponsor (after tigecycline LDOT data are received) and if at least 5 of 6 PK samples per patient have been received by central laboratory in acceptable condition for 10 to 12 patients in cohort. Treatment period of tigecycline will be a minimum of 3 days (unless patient is considered a treatment failure before this time) and a maximum of 14 days. On or after Day 4, based on investigator's decision, patients can switch to oral antibiotic therapy (to be chosen and provided by the investigator) and discharged after collection of planned PK samples.
    Intervention: Drug: Tygacil
  • Experimental: B
    1 mg/kg (up to a maximum dose of 50 mg for each dose) of tigecycline every 12 hours infused over approximately 30 minutes. Escalation to next dose cohort will occur only after safety and tolerability at preceding dose have been established by sponsor (after tigecycline LDOT data are received) and if at least 5 of 6 PK samples per patient have been received by the central laboratory in acceptable condition for 10 to 12 patients in the cohort. Treatment period of tigecycline will be a minimum of 3 days (unless the patient is considered a treatment failure before this time) and a maximum of 14 days. On or after Day 4, based on investigator's decision, patients can switch to oral antibiotic therapy (to be chosen and provided by the investigator) and discharged after collection of planned PK samples.
    Intervention: Drug: Tygacil
  • Experimental: C
    1.25 mg/kg (up to maximum dose of 50 mg for each dose) of tigecycline every 12 hours infused over approximately 30 minutes. Treatment period of tigecycline will be a minimum of 3 days (unless patient is considered a treatment failure before this time) and a maximum of 14 days. On or after Day 4, based on investigator's decision, patients can switch to oral antibiotic therapy (to be chosen and provided by the investigator) and discharged after collection of planned PK samples.
    Intervention: Drug: Tygacil
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.
 
Completed
59
September 2009
September 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria

  • 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.

Exclusion criteria

  • 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.
Sexes Eligible for Study: All
8 Years to 11 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Mexico,   South Africa,   Taiwan,   Ukraine,   United States
 
 
NCT00488345
3074K4-2207
No
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
September 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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