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

Phase 1

• Conditions: Complicated Intra-Abdominal Infection; MedDRA version: 9.1Level: LLTClassification code 10056570Term: Intra-abdominal infection

• Registration Number: EUCTR2008-005166-31-SI
• Lead Sponsor: Wyeth Pharmaceuticals Inc., acting through its division Wyeth Research, a Pfizer Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

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 <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). 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

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 <30 days). 2. 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. 3. 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). 4. 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. 5. Contraindication or hypersensitivity to any of the test articles that the subject may receive, including tetracycline (e.g., anaphylaxis). 6. 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. 7. Concurrent hemodialysis, hemofiltration, peritoneal dialysis, or plasmapheresis. 8. 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. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.