Complicated intra-abdominal infections (cIAI), complicated skin and skin structure infections (cSSSI), community-acquired pneumonia (CAP). MedDRA version: 9.1 Level: LLT Classification code 10056570 Term: Intra-abdominal infection MedDRA version: 9.1 Level: LLT Classification code 10040872 Term: Skin infection MedDRA version: 9.1 Level: LLT Classification code 10010120 Term: Community acquired pneumonia
Conditions
Interventions
Trade Name: Tygacil 50mg Powder for solution for Infusion
Product Name: Tygacil
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Tigecycline
CAS Number: 220620-09-7
Concentr
Sponsors
Wyeth Research Division of Wyeth Pharmaceutical Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female patients aged 8 to 11 years, inclusive. 2) Willing and able to complete all activities required for the study. 3) Anticipated length of antibiotic therapy = 5 days. 4) Have a diagnosis of a serious infection (eg, cIAI, cSSSI, or CAP) requiring hospitalization and administration of IV antibiotic therapy. 5) Specific criteria must also be satisfied for each specific sites of infection. (a) For patients with cIAI: · Be scheduled for or (within 48 hours before screening) have undergone a laparotomy, laparoscopy, or transrectal or percutaneous drainage of an intra-abdominal abscess. · Have a cIAI such as the following: - appendicitis complicated by perforation (grossly visible) and/or abscess; - purulent peritonitis or peritonitis associated with fecal contamination; - intra-abdominal abscess; - viscus perforation with symptoms lasting at least 12 hours before operation. · Have at least 2 of the following signs and symptoms: - abdominal tenderness or pain; - abdominal mass on physical examination; - ileus or hypoactive bowel sounds; - severe nausea and/or vomiting - evidence or suspicion of an intra-abdominal abscess or viscus perforation by radiography, scintigraphy, ultrasonography, computed tomography (CT), or magnetic resonance imaging (MRI) (b) For patients with cSSSI: · Have a cSSSI requiring significant surgical intervention or involving deeper soft tissue. This would include clinical entities such as the following: - infected ulcers or wounds that have developed signs of erythema, swelling, fluctuance, tenderness, pus, or warmth; - burns ( 10 cm in width or length (where anatomically applicable); - peripheral IV catheter sites with documented purulent drainage, provided that the catheter line will be removed; - infected human or animal bites. · Have at least 2 of the following signs and symptoms: - drainage and/or discharge; - erythema; - swelling and/or induration and/or fluctuance; - localized warmth; - pain and/or tenderness to palpation. (c) For patients with CAP: · Suspected bacterial rather than viral pneumonia. · Chest radiograph (posteroanterior/anteroposterior and if possible lateral views) within 48 hours before the first administration of IV test article showing the presence of an infiltrate. · Presence of at least 2 of the following: - dyspnea or tachypnea (respiratory rate > 30 breaths per minute); - cough; - production of purulent sputum or a change in sputum character consistent with bacterial infection; - auscultatory findings of rales and/or evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds or egophony); - hypoxemia with partial pressure of oxygen (PO2) 13 × 109/L [13,000/mm3]); OR > 15% immature neutrophils (bands); OR leukopenia with total WBC 38°C/100.4°F, oral temperature > 37.5°C/99.5°F, or axillary temperature > 37.2°C/99°F OR hypothermia, defined as rectal/core body temperature < 35°C/95°F Are the trial subj
Exclusion criteria
Exclusion criteria: 1) 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 (eg, life expectancy 10 mg of prednisone adult equivalent per day). 10) Receipt of an organ or bone marrow transplant. 11) Presence of any of the following laboratory findings: - Neutropenia (absolute neutrophil count 10 × the upper limit of normal (ULN) or bilirubin > 3 × ULN, unless isolated hyperbilirubinemia is directly related to the acute process (for patients with cIAI). 12) Pregnant or breastfeeding female patients and female patients of childbearing potential (ie, female patients are either biologically capable of becoming pregnant or have started their menses) who are unable or unwilling to take adequate contraceptive precautions. 13) Previous participation in this clinical trial. 14) Receipt any investigational drugs or devices (defined as lacking regulatory agency within 4 weeks before administration of the first dose of tigecycline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 (cIAI, cSSSI, CAP). ;Secondary Objective: ;Primary end point(s): No Primary Endpoints | — |
Countries
Belgium, United Kingdom
Outcome results
None listed