Phase 2
Completed N=58
Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age
Bacterial Infections · Intra-abdominal infection · Pneumonia, Bacterial · Skin Diseases, Bacterial
Source: ClinicalTrials.gov NCT00488345 ↗
Enrolled (actual)
58
Serious AEs
5.2%
Results posted
Oct 2012
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) — 456; 1515; 2599 ng/mL
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 pneumonia (CAP).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
456; 1515; 2599 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
0.6; 0.5; 0.8 | — |
| PRIMARY Area Under the Curve (AUCτ) From Time Zero to Time of Estimated Concentration at 12 Hours |
1650; 2557; 3196 | — |
| PRIMARY Weight Normalized Drug Clearance (CLW) |
0.490; 0.498; 0.528 | — |
| PRIMARY Percentage of Participants With Clinical Response (CR) to Tigecycline at Last Day of Therapy (LDOT) and Test-of-Cure (TOC) Assessment |
82.4; 52.4; 30.0; 17.6; 28.6; 55.0 | — |
| SECONDARY Population Pharmacokinetic (PK) Model: Volume of Distribution |
— | — |
| SECONDARY Population Pharmacokinetic (PK) Model: Clearance |
— | — |
| SECONDARY Population Pharmacokinetic (PK) Model: Effect of Weight |
— | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT00488345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.