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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 February 17, 2019

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.
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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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now