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Trial record 1 of 1 for:    NCT00827541
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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
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date January 20, 2009
First Posted Date January 22, 2009
Results First Submitted Date December 23, 2011
Results First Posted Date February 1, 2012
Last Update Posted Date February 1, 2012
Study Start Date August 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 23, 2011)
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.
Original Primary Outcome Measures
 (submitted: January 21, 2009)
Incidence of adverse events and serious adverse events [ Time Frame: 3 months ]
Change History Complete list of historical versions of study NCT00827541 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 23, 2011)
  • 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.
Original Secondary Outcome Measures
 (submitted: January 21, 2009)
Incidence of adverse events according to the type of infection [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post-Authorization Study Evaluating Safety Of Tigecycline
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
Brief Summary 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 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients hospitalized because of complicated intra-abdominal infections (cIAI) or complicated skin and soft tissue infections (cSSTI), in the usual health care setting
Condition
  • Intra-Abdominal Infections
  • Skin Disease, Infectious
  • Soft Tissues Infections
Intervention Drug: Tigecycline
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
Study Groups/Cohorts 1
Patients hospitalized because of cIAI or cSSTI
Intervention: Drug: Tigecycline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 11, 2011)
115
Original Estimated Enrollment
 (submitted: January 21, 2009)
500
Actual Study Completion Date December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Spain
 
Administrative Information
NCT Number NCT00827541
Other Study ID Numbers B1811048
3074A1-4401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2011