- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00488345
Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age
September 12, 2012 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brussels, Belgium, 1090
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Brussels, Belgium, 1200
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Guadalarajara Jalisco, Mexico, 0000
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Parow, South Africa, 7500
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Pretoria, South Africa, 0001
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Pretoria, South Africa, 00082
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Temba, South Africa, 00040
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Worcester, South Africa, 6850
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Taipei, Taiwan, 100
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Dnipropetrovsk, Ukraine, 49100
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Kharkov, Ukraine, 61098
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Kyiv, Ukraine, 0.0405
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Kyiv, Ukraine, 0.1133
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Kyiv, Ukraine, 4209
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Lviv, Ukraine, 79085
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Uzhorod, Ukraine, 88000
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Vinnitsa, Ukraine, 21021
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Vynnitsa
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Vinnitsa, Vynnitsa, Ukraine, 21021
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California
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Long Beach, California, United States, 90806
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Oakland, California, United States, 94609
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Orange, California, United States, 92868
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San Diego, California, United States, 92123
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Florida
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Tampa, Florida, United States, 33606
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Kentucky
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Louisville, Kentucky, United States, 40202
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Michigan
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Flint, Michigan, United States, 48503
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Mississippi
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Jackson, Mississippi, United States, 39218
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Nebraska
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Omaha, Nebraska, United States, 68131
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New York
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New York, New York, United States, 10032
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North Carolina
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Durham, North Carolina, United States, 27710
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Ohio
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Akron, Ohio, United States, 44308
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Cincinnati, Ohio, United States, 45229-3039
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033-0850
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Philadelphia, Pennsylvania, United States, 19104
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Pittsburgh, Pennsylvania, United States, 15213
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Utah
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Salt Lake City, Utah, United States, 84108
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Virginia
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Richmond, Virginia, United States, 23298
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Maximum Observed Plasma Concentration (Cmax)
Time Frame: Day 3 (immediately post-dose, 0.75, and 2 hours post-dose)
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Cmax: tigecycline serum concentration measured in nanograms per milliliter (ng/mL) determined by a validated liquid chromatography with mass spectrophotometric (LC/MS/MS) detection method.
Peak concentration was taken directly from the observed data.
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Day 3 (immediately post-dose, 0.75, and 2 hours post-dose)
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: Day 3 (immediately post-dose, 0.75, and 2 hours post-dose)
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Time of peak concentration taken directly from the observed data.
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Day 3 (immediately post-dose, 0.75, and 2 hours post-dose)
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Area Under the Curve (AUCτ) From Time Zero to Time of Estimated Concentration at 12 Hours
Time Frame: Day 3 (just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose)
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AUCτ: AUC between doses from time zero to the time of estimated concentration at 12 hours reported in nanograms * hours divided by milliliters (ng*h/mL) was calculated using the log-trapezoidal rule for decreasing concentrations and the linear-trapezoidal rule for increasing concentrations estimating the 12 hour drug concentration if necessary.
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Day 3 (just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose)
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Weight Normalized Drug Clearance (CLW)
Time Frame: Day 3 (just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose)
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Weight normalized drug clearance measured in liters per hour per kilogram (L/hr/kg).
Drug clearance (CL) was determined as the ratio of dose/area under the concentration-time curve from time zero (start of infusion) to 12 hours (start of next infusion) (AUCτ).
CLW was determined as the ratio of CL/weight.
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Day 3 (just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose)
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Percentage of Participants With Clinical Response (CR) to Tigecycline at Last Day of Therapy (LDOT) and Test-of-Cure (TOC) Assessment
Time Frame: Day 14 or LDOT, TOC Visit (10 to 21 days after last dose of total antibiotic therapy)
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CR = Cure: resolution of all signs, symptoms (SS) of infection (INF) or improvement, no further antibacterial therapy (AT) necessary; Improved (IMP): SS IMP to extent that switch to oral AT deemed appropriate; Failure: lack of response, required additional AT, initial recovery then deterioration requiring further AT, death due to the INF after day 2, death due to treatment (TR)-related adverse event (AE), required non-routine surgical TR >48 hours after 1st dose of TR due to failure to IMP or clinical worsening.
TOC = CR, vital signs, physical exam, laboratory results, concomitant TR, and AEs.
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Day 14 or LDOT, TOC Visit (10 to 21 days after last dose of total antibiotic therapy)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Population Pharmacokinetic (PK) Model: Volume of Distribution
Time Frame: 3074K4-2207: Day 3 just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose; 3074A1-110: just before and 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, and 48 hours after start of infusion
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Two compartment model with linear clearance and effect of weight on clearance using pooled PK data from 2 pediatric studies.
All concentration-time data were combined and analyzed using population PK methods to investigate potential influence of age, weight, and height (dose, tigecycline concentrations, times, subject weight, height, age, body surface area, serum creatinine, estimated creatinine clearance, serum bilirubin.
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3074K4-2207: Day 3 just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose; 3074A1-110: just before and 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, and 48 hours after start of infusion
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Population Pharmacokinetic (PK) Model: Clearance
Time Frame: 3074K4-2207: Day 3 just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose; 3074A1-110: just before and 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, and 48 hours after start of infusion
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Two compartment model with linear clearance and effect of weight on clearance using pooled PK data from 2 pediatric studies.
All concentration-time data were combined and analyzed using population PK methods to investigate potential influence of age, weight, and height (dose, tigecycline concentrations, times, subject weight, height, age, body surface area, serum creatinine, estimated creatinine clearance, serum bilirubin.
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3074K4-2207: Day 3 just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose; 3074A1-110: just before and 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, and 48 hours after start of infusion
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Population Pharmacokinetic (PK) Model: Effect of Weight
Time Frame: 3074K4-2207: Day 3 just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose; 3074A1-110: just before and 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, and 48 hours after start of infusion
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Two compartment model with linear clearance and effect of weight on clearance using pooled PK data from 2 pediatric studies.
All concentration-time data were combined and analyzed using population PK methods to investigate potential influence of age, weight, and height (dose, tigecycline concentrations, times, subject weight, height, age, body surface area, serum creatinine, estimated creatinine clearance, serum bilirubin.
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3074K4-2207: Day 3 just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose; 3074A1-110: just before and 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, and 48 hours after start of infusion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
June 18, 2007
First Submitted That Met QC Criteria
June 18, 2007
First Posted (Estimate)
June 20, 2007
Study Record Updates
Last Update Posted (Estimate)
October 24, 2012
Last Update Submitted That Met QC Criteria
September 12, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia
- Lung Diseases
- Disease Attributes
- Bacterial Infections and Mycoses
- Infections
- Communicable Diseases
- Intraabdominal Infections
- Skin Diseases, Infectious
- Skin Diseases
- Pneumonia, Bacterial
- Bacterial Infections
- Skin Diseases, Bacterial
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Tigecycline
Other Study ID Numbers
- 3074K4-2207
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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