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Bacterial InfectionsPhase 2NCT00488345

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

A Phase 2 study testing Tygacil in people with Bacterial Infections and Intra-Abdominal Infection, run by Wyeth is now a wholly owned subsidiary of Pfizer at 36 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 8 to 11 years
What is being tested?
Tygacil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
36 sitesin 6 countries
Study dates
Dec 2007to Sep 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 28Show fewer
  • 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.

Trial locations and contacts

36 sites in 6 countries.

36 sites in 6 countries

United States18 sites

  • Study site

    Akron, Ohio, 44308

  • Study site

    Cincinnati, Ohio, 45229-3039

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Flint, Michigan, 48503

  • Study site

    Hershey, Pennsylvania, 17033-0850

  • Study site

    Jackson, Mississippi, 39218

  • Study site

    Long Beach, California, 90806

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    New York, New York, 10032

  • Study site

    Oakland, California, 94609

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Orange, California, 92868

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Richmond, Virginia, 23298

  • Study site

    Salt Lake City, Utah, 84108

  • Study site

    San Diego, California, 92123

  • Study site

    Tampa, Florida, 33606

Other trials in United States

Ukraine9 sites

  • Study site

    Dnipropetrovsk, 49100

  • Study site

    Kharkiv, 61098

  • Study site

    Kyiv, Kyiv Oblast, 4209

  • Study site

    Kyiv, 0.0405

  • Study site

    Kyiv, 0.1133

  • Study site

    Lviv, Lviv Oblast, 79085

  • Study site

    Uzhhorod, Uzhorod, 88000

  • Study site

    Vinnitsa, Vynnitsa, 21021

  • Study site

    Vinnitsa, 21021

Other trials in Ukraine

South Africa5 sites

  • Study site

    Parow, 7500

  • Study site

    Pretoria, 0001

  • Study site

    Pretoria, 00082

  • Study site

    Themba, 00040

  • Study site

    Worcester, 6850

Other trials in South Africa

Belgium2 sites

  • Study site

    Brussels, 1090

  • Study site

    Brussels, 1200

Other trials in Belgium

Mexico1 site

  • Study site

    Guadalarajara Jalisco, 0000

Other trials in Mexico

Taiwan1 site

  • Study site

    Taipei, Taipei, 100

Other trials in Taiwan

About this study

Official title: 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).

Being tested
Tygacil
Keywords
cIAI, cSSSI, CAP, Child
Medical subject headings
Bacterial Infections, Intraabdominal Infections, Pneumonia, Bacterial, Skin Diseases, Bacterial, Skin Diseases, Infectious

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TygacilDrug

Study groups in NCT00488345
Study groupRoleWhat they receive
AExperimental0.75 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.
Receives: Drug: Tygacil
BExperimental1 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.
Receives: Drug: Tygacil
CExperimental1.25 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.
Receives: Drug: Tygacil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Plasma Concentration (Cmax)

    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.

    Measured: Day 3 (immediately post-dose, 0.75, and 2 hours post-dose)

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time of peak concentration taken directly from the observed data.

    Measured: Day 3 (immediately post-dose, 0.75, and 2 hours post-dose)

  3. Area Under the Curve (AUCτ) From Time Zero to Time of Estimated Concentration at 12 Hours

    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.

    Measured: Day 3 (just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose)

  4. Weight Normalized Drug Clearance (CLW)

    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.

    Measured: Day 3 (just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose)

  5. Percentage of Participants With Clinical Response (CR) to Tigecycline at Last Day of Therapy (LDOT) and Test-of-Cure (TOC) Assessment

    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.

    Measured: Day 14 or LDOT, TOC Visit (10 to 21 days after last dose of total antibiotic therapy)

Secondary outcomes (3)

  1. Population Pharmacokinetic (PK) Model: Volume of Distribution

    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.

    Measured: 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

  2. Population Pharmacokinetic (PK) Model: Clearance

    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.

    Measured: 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

  3. Population Pharmacokinetic (PK) Model: Effect of Weight

    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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionSep 2009
  4. Study completionSep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00488345
Sponsor's protocol ID
3074K4-2207
Status last verified
Sep 2012
First submitted
18 Jun 2007
Last updated
24 Oct 2012
Data monitoring committee
No

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.

    PubMed 22249106

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tygacil in people with Bacterial Infections and Intra-Abdominal Infection, run by Wyeth is now a wholly owned subsidiary of Pfizer at 36 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Ukraine, South Africa, Belgium, Mexico and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) (time frame: Day 3 (immediately post-dose, 0.75, and 2 hours post-dose)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00488345, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2012; AzTrials last refreshed its copy on 8 Nov 2026.

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