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Therapeutic Effectiveness and Safety Outcomes of Generic and Original Imipenem/Cilastatin in Hospitalized Patients: a multicenter non-inferiority study in Thailand

Therapeutic Effectiveness and Safety Outcomes of Generic and Original Imipenem/Cilastatin in Hospitalized Patients: a multicenter non-inferiority study in Thailand

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20210730004
Enrollment
520
Registered
2021-07-30
Start date
2017-11-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

serious infection Imipenem/Cilastatin Sianem Therapeutic Effectiveness Safety

Interventions

Subjects receive generic imipenem/cilastatin (Sianem) for treatment,Subjects receive original Tienam for treatment
Treatment,Treatment
Sianem ,Tienam

Sponsors

Siam Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Patients aged 18 years or above admitted to the hospital (2) Patients received imipenem/cilastatin (Tienam or Sianem)

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
clinical efficay and safety 2- 28 days during treatment clinical response and safety

Secondary

MeasureTime frame
bacteriological efficacy 2- 28 days during treatment bacteriological culture

Countries

Thailand

Contacts

Public ContactChusana Suankratay

Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Chulalongkorn University

csuankratay@gmail.com0818133755

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026