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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).
Details
| Lead sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 59 |
| Start date | 2007-12 |
| Completion | 2009-09 |
Conditions
- Bacterial Infections
- Intra-Abdominal Infection
- Pneumonia, Bacterial
- Skin Diseases, Bacterial
- Skin Diseases, Infectious
Interventions
- Tygacil
Primary outcomes
- Maximum Observed Plasma Concentration (Cmax) — Day 3 (immediately post-dose, 0.75, and 2 hours post-dose)
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. - Time to Reach Maximum Observed Plasma Concentration (Tmax) — Day 3 (immediately post-dose, 0.75, and 2 hours post-dose)
Time of peak concentration taken directly from the observed data. - Area Under the Curve (AUCτ) From Time Zero to Time of Estimated Concentration at 12 Hours — Day 3 (just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose)
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. - Weight Normalized Drug Clearance (CLW) — Day 3 (just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose)
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. - Percentage of Participants With Clinical Response (CR) to Tigecycline at Last Day of Therapy (LDOT) and Test-of-Cure (TOC) Assessment — Day 14 or LDOT, TOC Visit (10 to 21 days after last dose of total antibiotic therapy)
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.
Countries
United States, Belgium, Mexico, South Africa, Taiwan, Ukraine