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A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting

Pfizer logo

Pfizer

Status

Completed

Conditions

Infection

Treatments

Drug: tigecycline

Study type

Observational

Funder types

Industry

Identifiers

NCT00488488
B1811054 (Other Identifier)
3074A1-102045

Details and patient eligibility

About

To assess the efficacy and safety of Tygacil in the usual German hospital setting. The main goals are: to assess the efficacy of Tygacil under usual care conditions (cure rate); to assess the main side effects observed in daily medical practice (Safety of Tygacil); to determine whether patients are optimally dosed with Tygacil (according to the label) and the proportion of patients receiving a monotherapy versus combination therapy; to observe the potential resistance development against Tygacil in Germany; to determine which antibiotic agents are chosen for a combination therapy with Tygacil; to determine to which antibiotic substance non-responders to Tygacil are switched; to assess the duration of the intravenous therapy with Tygacil and to determine whether and which patients receive an oral antibiotic substance after the therapy with Tygacil; to collect information on profile, comorbidities and characteristics of patients treated with Tygacil.

Full description

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.

Enrollment

1,028 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Actual or planned therapy with tigecycline.
  • At least 18 years old.

Exclusion criteria

  • Hypersensitivity to antibiotics or tigecycline.

Trial design

1,028 participants in 1 patient group

A
Treatment:
Drug: tigecycline

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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