Post-Authorization Study Evaluating Safety Of Tigecycline

Study Overview
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Brief Summary
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This is a study to evaluate the safety of tigecycline in patients with complicated intra-abdominal infections (cIAI) and complicated skin and soft tissue infections (cSSTI) under real practice in the usual hospital setting and patients' conditions, in order to assess the real incidence of adverse events related with tigecycline in these patients.

Detailed Description
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Since around 50 patients were included in Spanish centers involved in the Phase III Tygacil clinical development program, and on the basis of the recruitment capacity of the centers within the predefined time window and the number of patients consenting to be enrolled in the study, the total number of patients estimated to be enrolled in the study is 500. With this sample size, it will be possible to obtain precise estimations of the incidence of particular types of adverse events.

Official Title
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A Phase IV Pharmacovigilance, Post-Authorization Clinical Trial To Evaluate And Assess The Safety Of Tigecycline In The Approved Indications In The Usual Health Care Setting

Conditions
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Intra-Abdominal Infections, Skin Disease, Infectious, Soft Tissues Infections

Intervention / Treatment
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* Drug: Tigecycline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent signed by patients prior to this study entry. 18 years of age or older at the screening visit. Patients with cIAI or cSSTI. Patients who are going to or have just been given in the previous 48 hours at least a dose of tigecycline to treat any of the above infections. In the opinion of the investigator, the patient will be able to comply with the requirements of the protocol. Exclusion Criteria: Known hypersensibility to tigecycline. Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception. Use any investigational drug within four weeks of the screening visit. Uncooperative patients or a history of poor compliance.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients hospitalized because of cIAI or cSSTI | Drug: Tigecycline<br>* Tigecycline 50 or 100 mg intravenously. Therapy conducted according to the package leaflet of Tygacil and to international treatment guidelines. Tygacil will be dosed according to labeling. The administration and duration of the therapy will be determined by the treating physician to meet the patient individual needs for treatment.<br>* Other names: Tygacil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Up to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Clinical Response of Cure | Cure was defined as complete resolution of infection symptoms and clinical signs of the disease to the extent that no further antibiotic treatment was required, as assessed by the attending physician. | Days 2-5, 7-14 and 21-28 during treatment and Days 1-3 after end of treatment | 
| Number of Participants With Susceptible Microbiological Pathogens | Evaluation of susceptibility to the tigecycline treatment included: Escherichia coli Extended Spectrum Beta Lactamases (E. coli ESBL); Klebsiella pneumoniae (K. pneumoniae) ESBL; Bacteroides species resistant to clindamycin (RClin); Staphylococcus aureus (S. aureus) methicillin resistant S. aureus (MRSA); vancomycin resistant Enterococcus (VRE) species; Resistant to third generation cephalosporins (RCef3) Enterobacter species; RCef3 Serratia species; Proteus species ESBL; carbapenem resistant (RCarb) Pseudomonas aeruginosa (P. aeruginosa); Acinetobacter baumannii (A. baumannii) RCarb. | Baseline and Week 12 | 
| Number of Participants With Eradication of Microbiological Pathogens | Evaluation of eradication after treatment with tigecycline included following microbiological pathogens: E. coli ESBL; K. pneumoniae ESBL; Bacteroides species RClin; S. aureus (MRSA); Enterococcus species (VRE); Enterobacter species RCef3; Serratia species RCef3; Proteus species ESBL; P. aeruginosa RCarb; A. baumannii RCarb. | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tigecycline, complicated intra-abdominal infections (cIAI), complicated skin and soft tissue infections (cSSTI).