A Multicenter, Open-Label, Ascending Multiple-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age With Selected Serious Infections

Conditions: Complicated intra-abdominal infections (cIAI), complicated skin and skin structure infections (cSSSI), community-acquired pneumonia (CAP).
MedDRA version: 14.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: PTClassification code 10040872Term: Skin infectionSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: LLTClassification code 10056570Term: Intra-abdominal infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2007-002120-14-Outside-EU/EEA

Lead Sponsor: Wyeth Parmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc, 500 Arcola Road, Collegeville, PA 19426 USA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 72

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 (< 20% body surface area, nonfull-thickness);
-major abscess (not treatable through surgery alone);
-deep or extensive cellulitis, either in an underlying disease state or > 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) < 60 mm Hg or oxygen saturation < 90% while the patient is breathing room air, as determined by pulse oximetry or arterial blood gas (ABG);
-leukocytosis (white blood cell count [WBC] > 13 × 109/L [13,000/mm3]); OR > 15% immature neutrophils (bands); OR leukopenia with total WBC < 4.5 × 109/L (4,500/mm3).
·The presence of either of the following:
- fever (within the 24 hours before randomization”/enrollment), defined as a rectal/core temperature > 38°C/100.4°F, oral temperature > 37.5°C/99.5°F,

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 < 30 days).
2)For cSSSI patients, the presence of decubitus ulcers, necrotizing fasciitis, gas gangrene, or skeletal infection.
3)Endocarditis; presence of an artificial heart valve or infected device that will not be removed.
4)CAP patients who have been hospitalized within 14 days before the onset of symptoms.
5)Patients with any of the following conditions:
-Cystic fibrosis.
-Active tuberculosis.
-Congenital immunodeficiency.
-Meningitis.
-Septic shock.
-Osteomyelitis (suspected or evident).
-Refractory shock syndrome in which hemodynamic parameters cannot be maintained despite adequate supportive therapy.
-Confirmed malignancy with patient receiving an active course of chemotherapeutic agents.
-Known or suspected infection with human immunodeficiency virus (HIV) or positive test result for HIV antibody.
-Known or suspected concomitant bacterial or parasitic infection requiring systemic treatment.
6)Presence of any of the following for patients with pneumonia:
-Postobstructive pneumonia.
-Pulmonary abscess.
-Empyema.
-Known or suspected pulmonary infection with Pneumocystis carinii.
7)Known or suspected hypersensitivity to tigecycline or other compounds related to this class of antibacterial agents (ie, tetracyclines).
8)Known or suspected P. aeruginosa infection.
9)Patients receiving immunosuppressive therapy that, in the opinion of the investigator, would decrease the patient’s ability to eradicate the infection, including the use of high-dose corticosteroids (eg, chronic [for = 3 weeks before randomization”/enrollment] use of > 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 < 1 × 109/L [< 1000/mm3]).
-Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Not applicable as secondary objectives are not listed in the protocol.;Primary end point(s): No Primary Endpoints;Timepoint(s) of evaluation of this end point: Not applicable;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 Outcome Measures

Name	Time	Method
Secondary end point(s): No secondary endpoints;Timepoint(s) of evaluation of this end point: Not applicable

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