Predictors and Outcomes of Meropenem Treatment Failure Among Patients With Septic Shock in Intensive Care Unit

• Conditions: Predictors and Outcomes of Meropenem Treatment Failure
• Interventions: Other: no intervention

• Registration Number: NCT04042662
• Lead Sponsor: Universiti Sains Malaysia

Brief Summary

Lately, the inappropriate used of Meropenem in critically ill patient were increased. Therefore, increased development of drug resistance bacteria towards Meropenem.

As known that Carbapenem-Resistance Enterobacteriaceae (CRE) is part of complication when Meropenem is widely used in the intensive care unit. CRE are very difficult to treat within Gram negative bacteria as it encodes Carbapenemase enzyme which breaks down Carbapenem anti-microbial such as Meropenem. The widespread carbapenemase production in the Enterobacteriaceae was unknown until the early 2000 until first reported in 2001. Despite that, most doctors and physician favourite, and still prescribe Meropenem as the antibiotic of choice for the critically ill patients empirically. This is because of its broad spectrum of coverage for bacteria. Thus, a number of Meropenem treatment failure were increased as resistance increase.This study will evaluate the appropriate use of Meropenem and determine the predictors of Meropenem treatment failure as well as the patient outcomes.As a result, it can be a guidance prior prescribing the Meropenem base on patient clinical condition and parameters while balancing the risk and benefits of its used.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-30
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-01
• Last Update Submitted: 2019-08-01
• Study First Posted: 2019-08-02
• Last Update Posted: 2019-08-02
• Study Start: 2019-08-05
• Primary Completion: 2020-08-05
• Study Completion: 2020-08-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Septic shock patient admitted to ICU
2. Age equal or more than 18 years old (No upper limit of age)
3. Receive Meropenem for at least 3 days

Exclusion Criteria

1. Meropenem as prophylaxis
2. Patient who had culture Carbapenem Resistant Enterobacteriaceae organism (CRE)
3. Patient who admitted with proven diagnosis of Cardiogenic shock

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Meropenem Success ( Treatment Success)	no intervention	-
Meropenem Failure ( Treatment failure)	no intervention	-

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment failure with antibiotic meropenem as assessed by clinical criteria of sepsis parameters among patient	3 years	with septic shock in intensive care unit.
Number of factors associated with antibiotic meropenem treatment failure among patient	3 years	with septic shock in intensive care unit.
Number of the patients who die after treated with antibiotic meropenem in intensive care unit	3 years	Mortality