Bacterial Infection Imipenem/Cilastatin Efficacy Safety
Conditions
Interventions
Imipemen/Cilastatin IV injection (A)
,Imipemen/Cilastatin IV injection (B)
Active Comparator Drug,Experimental Drug
Imipemen/Cilastatin 500/500 mg,Imipemen/Cilastatin 500/500 mg
Sponsors
Siam Pharmaceutical Co., Ltd.
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 and one of the following (2) Bacterial Infections
Exclusion criteria
Exclusion criteria: (1)Hypersensitivity to carbapenems (2)Patients who have epilepsy or seizure or previous history of seizure during imipenem treatment or receive anticonvulsant drug, e.g. sodium valproate (3)Antimicrobial susceptibility testing demonstrating imipenem/cilastatin or carbapenems resistance among the suspected or definite pathogens (4)Patient who received carbapenems one month prior to enrolment (5)Patient has expected to die within 48 hours (6)Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Effectiveness 7-14 days after end of treatment clinical outcome assessment by numbering 1-4 based on physical examination and laboratory examinatio,Safety during treatment and up to the 7-14 days after the end of treatment Adverse events possibly related to imipenem/cilastatin treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Effectiveness 48-72 hours of treatment and the end of treatment clinical outcome assessment by numbering 1-4 based on physical examination and laboratory examinatio,Bacteriological Eradication 7-14 days after end of treatment Bacterial culture results | — |
Contacts
Public ContactChusana Suankratay
Division of Infectious Diseases, Department of Medicine, Chulalongkorn University
Outcome results
None listed