Complicated Intra-Abdominal Infection MedDRA version: 9.1 Level: LLT Classification code 10056570 Term: Intra-abdominal infection
Conditions
Interventions
Trade Name: Tygacil 50 mg powder for solution for
infusion
Product Name: Tygacil (Tigecycline)
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Tigecycline
CAS Number: 220620
Sponsors
Wyeth Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects 8 to 17 years old. Children with bone maturation less than 8 years old should be enrolled with caution due to potential risk of tooth discoloration. 2. Have a diagnosis of a serious infection (cIAI) requiring hospitalization and administration of IV antibiotic therapy. 3. Anticipated length of antibiotic therapy greater than or equal to 5 days. 4. The following criteria must also be satisfied: a) Be scheduled for or within 48 hours before screening have had a laparotomy, laparoscopy, or transrectal or percutaneous drainage of an intra-abdominal abscess. b) Have a cIAI which would include clinical entities such as (the following are examples): - complicated appendicitis [e.g., gangrenous, perforation (grossly visible) and abscess and/or periappendicular abscess]; - purulent peritonitis or peritonitis associated with fecal contamination; - intra-abdominal abscess, including those that develop in a post-operative subject; and - viscus perforation (with evidence of peritonitis or intra-abdominal abscess) with symptoms lasting at least 12 hours before operation. c) Have at least 1 of the following signs of systemic infection: - fever (within the 24 hours before randomization) defined as a core temperature >38.5 degree C or 13.5 x 109/L (13,500/mm3) for age 8 to 12, >11 x 109/L (11,000/mm3) for age 13 to 17, 10% immature neutrophils (bands); - positive blood culture; and - any 2 of the following: systolic blood pressure 130 beats/min (age 8 to 12) or >110 beats/min (age 13 to 17), or respiratory rate >18 breaths/min (age 8 to 12) or >14 breaths/min (age 13 to 17). d) Have at least 2 of the following signs and symptoms: - abdominal tenderness or pain; - abdominal mass on physical examination; - ileus or hypoactive bowel sounds; and - evidence or suspicion of an intra-abdominal abscess by radiography, scintigraphy, ultrasonography, computerized tomography (CT) scan, or magnetic resonance imaging (MRI). 5. All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 1 month after the last dose of any test article. A subject is biologically capable of having children even if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject with any concomitant illness/condition that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in and/or completion of the study, or could preclude the evaluation of the subject’s response (e.g., life expectancy 5 x the upper limit of normal (ULN); and - Bilirubin >3 x ULN, unless isolated hyperbilirubinemia is directly related to the acute process. 9. Participated in any investigational studies of drugs or devices within 4 weeks before administration of the first dose of test article. 10. Pregnant or nursing female.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the safety of tigecycline versus a ceftriaxone regimen in the treatment of pediatric subjects (ages 8 to 17 years) with selected serious infections (cIAI).;Secondary Objective: 1. To evaluate clinical and microbiological efficacy of tigecycline in the pediatric population. 2. To evaluate the PK and PD profiles of tigecycline in pediatric subjects with cIAI. 3. To obtain in vitro susceptibility data on tigecycline for a range of bacterial pathogens isolated from subjects with cIAI.;Primary end point(s): The assessment of safety of tigecycline versus ceftriaxone is the primary objective of this study. Safety will be evaluated by collection of adverse events, laboratory assessments, physical examinations, vital signs measurements and electrocardiograms. | — |
Countries
Belgium, Hungary, Slovenia, United Kingdom
Outcome results
None listed