Post-Authorization Study Evaluating Safety Of Tigecycline (HORUS)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00827541

First received: January 20, 2009

Last updated: December 23, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 20, 2009

Last Updated Date

December 23, 2011

Start Date ^ICMJE

August 2008

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 12 ] [ Designated as safety issue: Yes ]

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 ^ICMJE

Incidence of adverse events and serious adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00827541 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ^ICMJE

Incidence of adverse events according to the type of infection [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Post-Authorization Study Evaluating Safety Of Tigecycline

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Intra-Abdominal Infections
Skin Disease, Infectious
Soft Tissues Infections

Intervention ^ICMJE

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 Group/Cohort (s)

Patients hospitalized because of cIAI or cSSTI

Intervention: Drug: Tigecycline

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

115

Completion Date

December 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00827541

Other Study ID Numbers ^ICMJE

B1811048, 3074A1-4401

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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