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

Predictors and Outcomes of Meropenem Treatment Failure Clinical Trial

— Meropenem  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04042662
• Other study ID #: MeropenemUSM
• Status: Not yet recruiting
• Start date: August 5, 2019
• Est. completion date: August 5, 2020

Study information

• Verified date: August 2019
• Source: University of Science Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: August 5, 2020
• Est. primary completion date: August 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Predictors and Outcomes of Meropenem Treatment Failure
• Shock, Septic

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Science Malaysia

Outcome

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