Post-Authorization Study Evaluating Safety Of Tigecycline

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Intra-Abdominal Infections Skin Disease, Infectious Soft Tissues Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients hospitalized because of cIAI or cSSTI

Tigecycline

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Tygacil

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No