Post-Authorization Study Evaluating Safety Of Tigecycline (HORUS)
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|ClinicalTrials.gov Identifier: NCT00827541|
Recruitment Status : Completed
First Posted : January 22, 2009
Results First Posted : February 1, 2012
Last Update Posted : February 1, 2012
|Condition or disease||Intervention/treatment|
|Intra-Abdominal Infections Skin Disease, Infectious Soft Tissues Infections||Drug: Tigecycline|
|Study Type :||Observational|
|Actual Enrollment :||115 participants|
|Official Title:||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|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Patients hospitalized because of cIAI or cSSTI
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.
Other Name: Tygacil
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 12 ]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.
- Percentage of Participants With Clinical Response of Cure [ Time Frame: Days 2-5, 7-14 and 21-28 during treatment and Days 1-3 after end of treatment ]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.
- Number of Participants With Susceptible Microbiological Pathogens [ Time Frame: Baseline and Week 12 ]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.
- Number of Participants With Eradication of Microbiological Pathogens [ Time Frame: Week 12 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00827541
|Study Director:||Pfizer CT.gov Call Center||Pfizer|