A Phase 3, Multicenter, Randomized, and Double-blind Study to Evaluate the Safety of Tigecycline versus a Ceftriaxone Regimen in the Treatment of Complicated Intra-abdominal Infections and Community-acquired Pneumonia in Pediatric Subjects Ages 8 to 17 Years Old
- Conditions
- -K65-A499 Bacterial infection, unspecifiedBacterial infection, unspecifiedA499K65
- Registration Number
- PER-103-09
- Lead Sponsor
- WYETH RESEARCH,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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 <36 degree C (other methods are accepted); - white blood cell (WBC) count >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, <4.5 x 109/L (4,500/mm3) or, >10% immature neutrophils (bands); - positive blood culture; and - any 2 of the following: systolic blood pressure <105 mm Hg (age 8 to 12) or <117 mm Hg (age 13 to 17), tachycardia >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.
• 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 <30 days).
• Received more than 24 hours of potentially effective systemic antibiotic therapy before first dose of test article (except if for prophylactic/perioperative use) to treat the current infection, unless subject has been declared a clinical failure (no clinical improvement after 48 hours of treatment) or the causative organism(s) has been shown to be resistant to prior antibiotics. Note: Subject may not have failed therapy with any antibiotic where cross resistance would be expected with an antibiotic used in this study.
• Infection due to a pathogenic organism known or suspected to be resistant to the study related antibiotics the subject may receive (e.g., before test article administration).
• Subjects with any of the following conditions: - viscus perforation without evidence of peritonitis or intra-abdominal abscess; - pelvic inflammatory disease (any infection of the female genital-urinary track); - endocarditis; - infected device that will not be removed; - cystic fibrosis; - active tuberculosis; - congenital immunodeficiency; - meningitis; - severe sepsis; - refractory shock (e.g., in which hemodynamic parameters cannot be maintained despite adequate volume replacement); - confirmed malignancy in a subject receiving active course(s) of chemotherapeutic agents; - known or suspected infection with human immunodeficiency virus (HIV) (e.g., positive HIV antibody); - known or suspected concomitant infection requiring systemic treatment; - suspected inflammatory bowel disease.
• Contraindication or hypersensitivity to any of the test articles that the subject may receive, including tetracycline (e.g., anaphylaxis).
• Subjects receiving immunosuppressive therapy that, in the opinion of the investigator, would decrease the subject’s ability to eradicate the infection, including use of high dose corticosteroids.
• Concurrent hemodialysis, hemofiltration, peritoneal dialysis, or plasmapheresis.
• Presence of any of the following laboratory findings: - Neutropenia (absolute neutrophil count <1 x 109/L [<1000/mm3]); - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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.<br>Measure:Clinical Response<br>Timepoints:During the study<br>
- Secondary Outcome Measures
Name Time Method