Post-Authorization Study Evaluating Safety Of Tigecycline

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.

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Key information

Conditions

Intra-Abdominal Infections Infections Intraabdominal Infections Skin Disease, Infectious Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Soft Tissue Infections Soft Tissues Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tigecycline

Drug

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 names: Tygacil

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Acronym: HORUS

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Jan 22, 2009
Registry last updated: Feb 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed