A Phase 2 interventional study of Tygacil in Bacterial Infections, Intra-Abdominal Infection and Pneumonia, Bacterial, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 36 sites in 6 countries. Open to participants aged 8 Years to 11 Years. Per ClinicalTrials.gov, last updated 2012-10-24.
Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer (part of Pfizer) · Phase 2, Interventional, and Treatment
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).
665 studies on the registry are indexed under Bacterial Infections; 99 are open to participants now.
This study's enrollment of 59 is below the median of 80 across 410 interventional studies indexed under Bacterial Infections.
Browse Bacterial Infections studies →Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 484 studies on the registry; none are open to participants now.
First submitted before Wyeth became part of Pfizer.
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Exclusion criteria
Patients with any of the following conditions:
CAP Patients: Presence of any of the following for patients with pneumonia:
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.
Drug: Tygacil
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.
Drug: Tygacil
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.
Drug: Tygacil
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.
Time frame: Day 3 (immediately post-dose, 0.75, and 2 hours post-dose)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time of peak concentration taken directly from the observed data.
Time frame: Day 3 (immediately post-dose, 0.75, and 2 hours post-dose)
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.
Time frame: Day 3 (just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose)
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.
Time frame: Day 3 (just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose)
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.
Time frame: Day 14 or LDOT, TOC Visit (10 to 21 days after last dose of total antibiotic therapy)
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.
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
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.
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
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.
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
| Milestone | Tigecycline 0.75 mg/kg | Tigecycline 1 mg/kg | Tigecycline 1.25 mg/kg |
|---|---|---|---|
| Started | 17 | 21 | 20 |
| Completed | 17 | 17 | 17 |
| Not completed | 0 | 4 | 3 |
| Withdrew: Adverse event | 0 | 1 | 1 |
| Withdrew: Unable to administer antibiotics at home | 0 | 1 | 0 |
| Withdrew: Institutional review board review | 0 | 0 | 1 |
| Withdrew: Surgical team recommendation | 0 | 1 | 0 |
| Withdrew: Parent/legal guardian request | 0 | 1 | 1 |
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.
| ng/mL | Tigecycline 0.75 mg/kg | Tigecycline 1 mg/kg | Tigecycline 1.25 mg/kg |
|---|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | 456 ± 347 | 1515 ± 1457 | 2599 ± 3643 |
Time of peak concentration taken directly from the observed data.
| hours | Tigecycline 0.75 mg/kg | Tigecycline 1 mg/kg | Tigecycline 1.25 mg/kg |
|---|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0.6 ± 0.2 | 0.5 ± 0.1 | 0.8 ± 0.6 |
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.
| ng*h/mL | Tigecycline 0.75 mg/kg | Tigecycline 1 mg/kg | Tigecycline 1.25 mg/kg |
|---|---|---|---|
| Area Under the Curve (AUCτ) From Time Zero to Time of Estimated Concentration at 12 Hours | 1650 ± 529 | 2557 ± 1196 | 3196 ± 1704 |
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.
| L/hr/kg | Tigecycline 0.75 mg/kg | Tigecycline 1 mg/kg | Tigecycline 1.25 mg/kg |
|---|---|---|---|
| Weight Normalized Drug Clearance (CLW) | 0.490 ± 0.130 | 0.498 ± 0.335 | 0.528 ± 0.384 |
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.
No measurements were reported for this outcome.
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.
| percentage of participants | Tigecycline 0.75 mg/kg | Tigecycline 1 mg/kg | Tigecycline 1.25 mg/kg |
|---|---|---|---|
| Cure: LDOT | 82.4 | 52.4 | 30.0 |
| Improved: LDOT | 17.6 | 28.6 | 55.0 |
| Failure: LDOT | 0.0 | 0.0 | 0.0 |
| Indeterminate: LDOT | 0.0 | 19.0 | 15.0 |
| Cure: TOC | 94.1 | 76.2 | 75.0 |
| Failure: TOC | 5.9 | 4.8 | 10.0 |
| Indeterminate: TOC | 0.0 | 19.0 | 15.0 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tigecycline 0.75 mg/kg | — | 1/17 (5.9%) | 11/17 (64.7%) |
| Tigecycline 1 mg/kg | — | 1/21 (4.8%) | 16/21 (76.2%) |
| Tigecycline 1.25 mg/kg | — | 1/20 (5%) | 17/20 (85%) |
| Event | Tigecycline 0.75 mg/kg | Tigecycline 1 mg/kg | Tigecycline 1.25 mg/kg |
|---|---|---|---|
| Postoperative wound infectionInfections and infestations | 1/17 | 0/21 | 0/20 |
| Abdominal painGastrointestinal disorders | 0/17 | 0/21 | 1/20 |
| Anal fistulaGastrointestinal disorders | 0/17 | 1/21 | 0/20 |
| Event | Tigecycline 0.75 mg/kg | Tigecycline 1 mg/kg | Tigecycline 1.25 mg/kg |
|---|---|---|---|
| NauseaGastrointestinal disorders | 3/17 | 13/21 | 12/20 |
| VomitingGastrointestinal disorders | 5/17 | 11/21 | 11/20 |
| DiarrhoeaGastrointestinal disorders | 2/17 | 1/21 | 0/20 |
| Lipase increasedInvestigations | 0/17 | 2/21 | 2/20 |
| ConvulsionNervous system disorders | 0/17 | 2/21 | 0/20 |
| ThrombocythaemiaBlood and lymphatic system disorders | 1/17 | 0/21 | 0/20 |
| Abdominal painGastrointestinal disorders | 1/17 | 1/21 | 1/20 |
| Chapped lipsGastrointestinal disorders | 1/17 | 0/21 | 0/20 |
| Catheter site related reactionGeneral disorders | 1/17 | 0/21 | 0/20 |
| PyrexiaGeneral disorders | 1/17 | 0/21 | 0/20 |
| Age Continuous(years) | Tigecycline 0.75 mg/kg | Tigecycline 1 mg/kg | Tigecycline 1.25 mg/kg | Total |
|---|---|---|---|---|
| Mean | 10.21 ± 1.15 | 10.20 ± 1.06 | 9.72 ± 0.94 | 10.04 ± 1.05 |
| Sex: Female, Male(Participants) | Tigecycline 0.75 mg/kg | Tigecycline 1 mg/kg | Tigecycline 1.25 mg/kg | Total |
|---|---|---|---|---|
| Female | 9 | 10 | 8 | 27 |
| Male | 8 | 11 | 12 | 31 |
| Selected Serious Infections(participants) | Tigecycline 0.75 mg/kg | Tigecycline 1 mg/kg | Tigecycline 1.25 mg/kg | Total |
|---|---|---|---|---|
| Community Acquired Pneumonia | 7 | 8 | 4 | 19 |
| Complicated Intra-abdominal Infection | 6 | 6 | 12 | 24 |
| Complicated Skin and Skin Structure Infection | 4 | 7 | 4 | 15 |
The record gives a start of Dec 2007, a primary completion of Sep 2009 and a completion of Sep 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2012, 3 years 1 month after primary completion.
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This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tigecycline
Wyeth is now a wholly owned subsidiary of Pfizer →