Predictors and Outcomes of Meropenem Treatment FailureMeropenemNCT04042662
Predictors and Outcomes of Meropenem Treatment Failure Among Patients With Septic Shock in Intensive Care Unit
An observational study of Predictors and Outcomes of Meropenem Treatment Failure, run by Universiti Sains Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Predictors and Outcomes of Meropenem Treatment Failure
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2019to 5 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Reference population is septic shock patient who was prescribed with Meropenem and admitted to ICU HUSM from 01/01/2016 - 01/06/2019
Who may be able to join
- Septic shock patient admitted to ICU
- Age equal or more than 18 years old (No upper limit of age)
- Receive Meropenem for at least 3 days
Who cannot join
- Meropenem as prophylaxis
- Patient who had culture Carbapenem Resistant Enterobacteriaceae organism (CRE)
- Patient who admitted with proven diagnosis of Cardiogenic shock
About this study
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.
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Meropenem Failure ( Treatment failure) | Not described Receives: Other: no intervention | |
| Meropenem Success ( Treatment Success) | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Number of factors associated with antibiotic meropenem treatment failure among patient
with septic shock in intensive care unit.
Measured: 3 years
Number of the patients who die after treated with antibiotic meropenem in intensive care unit
Mortality
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start5 Aug 2019 (estimated)
- Primary completion5 Aug 2020 (estimated)
- Study completion5 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Predictors and Outcomes of Meropenem Treatment FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mohd Zulfakar Mazlan, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042662
- Sponsor's protocol ID
- MeropenemUSM
- Acronym
- Meropenem
- Status last verified
- Aug 2019
- First submitted
- 30 Jul 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors and Outcomes of Meropenem Treatment Failure Among Patients With Septic Shock in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04042662
- Acronym / sponsor ID
- Meropenem / MeropenemUSM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 5 Aug 2019 (estimated)
- Primary completion
- 5 Aug 2020 (estimated)
- Study completion
- 5 Aug 2020 (estimated)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meropenem Failure ( Treatment failure) | – | Other: no intervention |
| Meropenem Success ( Treatment Success) | – | Other: no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Reference population is septic shock patient who was prescribed with Meropenem and admitted to ICU HUSM from 01/01/2016 - 01/06/2019
Key inclusion criteria (3 listed)
- Septic shock patient admitted to ICU
- Age equal or more than 18 years old (No upper limit of age)
- Receive Meropenem for at least 3 days
Key exclusion criteria (3 listed)
- Meropenem as prophylaxis
- Patient who had culture Carbapenem Resistant Enterobacteriaceae organism (CRE)
- Patient who admitted with proven diagnosis of Cardiogenic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | Meropenem Failure ( Treatment failure), Meropenem Success ( Treatment Success) |
Primary outcome
Number of participants with treatment failure with antibiotic meropenem as assessed by clinical criteria of sepsis parameters among patient
Time frame: 3 years
with septic shock in intensive care unit.
Number of factors associated with antibiotic meropenem treatment failure among patient
Time frame: 3 years
with septic shock in intensive care unit.
Number of the patients who die after treated with antibiotic meropenem in intensive care unit
Time frame: 3 years
Mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Predictors and Outcomes of Meropenem Treatment Failure, run by Universiti Sains Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment failure with antibiotic meropenem as assessed by clinical criteria of sepsis parameters among patient (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.