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Post-Authorization Study Evaluating Safety Of Tigecycline (HORUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment
Intra-Abdominal Infections Skin Disease, Infectious Soft Tissues Infections Drug: Tigecycline

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
Actual Enrollment : 115 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Tigecycline
U.S. FDA Resources

Group/Cohort Intervention/treatment
1
Patients hospitalized because of cIAI or cSSTI
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00827541     History of Changes
Other Study ID Numbers: B1811048
3074A1-4401
First Posted: January 22, 2009    Key Record Dates
Results First Posted: February 1, 2012
Last Update Posted: February 1, 2012
Last Verified: December 2011

Keywords provided by Pfizer:
tigecycline
complicated intra-abdominal infections (cIAI)
complicated skin and soft tissue infections (cSSTI).

Additional relevant MeSH terms:
Infection
Communicable Diseases
Skin Diseases
Intraabdominal Infections
Soft Tissue Infections
Skin Diseases, Infectious
Tigecycline
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents