None listed
Conditions
Interventions
Group 1 Type of group
Tigecycline 50 mg IV at 0, 8, 12, 16 hours + metronidazole placebo
Group name:Group 2 Type of group
Ceftriaxone 1g IV at hours 0 and 12 + metronidazole
Sponsors
WYETH RESEARCH,
Eligibility
Age
8 Years to 17 Years
Inclusion criteria
Inclusion criteria: • 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. • Have a diagnosis of a serious infection (cIAI) requiring hospitalization and administration of IV antibiotic therapy. • Anticipated length of antibiotic therapy greater than or equal to 5 days. • 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). • 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.
Exclusion criteria
Exclusion criteria: • 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. • Participated in any investigational studies of drugs or devices within 4 weeks before administration of the first dose of test article. • Pregnant or nursing female.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Healing, failure or indeterminate) in the TOC visit for 2 co-primary populations: the clinically evaluable population (EC) the population with the intention to treat modified clinical. Measure:Clinical Response Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The microbioiotic response at the level of the subject and at the level of the pathogenic microorganism will be programmatically determined by the sponsor according to the results of the cultures of the selection, the sensitivities of the microorganisms identified and the clinical response of the subject assigned by the researcher. Microbiological responses will be generated in the evaluations of LDOT IV, TOC and FUP. Measure:Microbiological response at the subject level Timepoints:During the study ; Outcome name:The microbioiotic response at the level of the pathogenic microorganism will be programmatically determined by the sponsor according to the results of the cultures of the selection, the sensitivities of the microorganisms identified and the clinical response of the subject assigned by the researcher. Microbiological responses will be generated in the evaluations of LDOT IV, TOC and FUP. Measure:Microbiological response at the level of the pathogenic microorganism Timepoints:During the study | — |
Countries
Belgium, Hungary, Peru, Slovenia, United Kindgdom
Contacts
Public ContactJusto Romulo Padilla
LABORATORIOS WYETH S.A.
Outcome results
None listed