Clinical trial NCT00827541: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intra-Abdominal Infections
Skin Disease, Infectious
Soft Tissues Infections
Keywords: tigecycline
complicated intra-abdominal infections (cIAI)
complicated skin and soft tissue infections (cSSTI).
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-22
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Week 12
Secondary outcomes:
measure: Percentage of Participants With Clinical Response of Cure
timeFrame: Days 2-5, 7-14 and 21-28 during treatment and Days 1-3 after end of treatment
measure: Number of Participants With Susceptible Microbiological Pathogens
timeFrame: Baseline and Week 12
measure: Number of Participants With Eradication of Microbiological Pathogens
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Bassetti M, Eckmann C, Bodmann KF, Dupont H, Heizmann WR, Montravers P, Guirao X, Capparella MR, Simoneau D, Sanchez Garcia M. Prescription behaviours for tigecycline in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii5-14. doi: 10.1093/jac/dkt140.
citation: Guirao X, Sanchez Garcia M, Bassetti M, Bodmann KF, Dupont H, Montravers P, Heizmann WR, Capparella MR, Simoneau D, Eckmann C. Safety and tolerability of tigecycline for the treatment of complicated skin and soft-tissue and intra-abdominal infections: an analysis based on five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii37-44. doi: 10.1093/jac/dkt143.
citation: Montravers P, Bassetti M, Dupont H, Eckmann C, Heizmann WR, Guirao X, Garcia MS, Capparella MR, Simoneau D, Bodmann KF. Efficacy of tigecycline for the treatment of complicated skin and soft-tissue infections in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii15-24. doi: 10.1093/jac/dkt141.