Therapeutic Outcomes of Two Preparations of Imipenem/Cilastatin in Hospitalized Patients

Phase 4

Active, not recruiting

• Conditions: Bacterial Infection; Efficacy; Safety; Imipenem/Cilastatin

• Registration Number: TCTR20150708001
• Lead Sponsor: Siam Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-08
• Study Completion: 2016-05-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

(1)Patients aged 18 years or above admitted to the hospital and one of the following
(2) Bacterial Infections

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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