Therapeutic Effectiveness and Safety Outcomes of Generic and Original Imipenem/Cilastatin in Hospitalized Patients: a multicenter non-inferiority study in Thailand
Completed
- Conditions
- serious infectionImipenem/CilastatinSianemTherapeutic EffectivenessSafety
- Registration Number
- TCTR20210730004
- Lead Sponsor
- Siam Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 441
Inclusion Criteria
(1)Patients aged 18 years or above admitted to the hospital
(2)Patients received imipenem/cilastatin (Tienam or Sianem)
Exclusion Criteria
(1)Patient s medical records were not available.
(2)Patients received imipenem/cilastatin less than 48 hours.
(3)Patients received both generic and original imipenem/cilastatin continuously within the same admission.
(4)Patient received carbapenems 14 days prior to the study.
(5)Antimicrobial susceptibility testing demonstrating imipenem/cilastatin or carbapenems resistance among the suspected or definite pathogens.
(6)Patient died within 48 hours after treatment.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method clinical efficay and safety 2- 28 days during treatment clinical response and safety
- Secondary Outcome Measures
Name Time Method bacteriological efficacy 2- 28 days during treatment bacteriological culture