SepsisPhase 4NCT03645668

Efficacy and Pharmacokinetics of Meropenem in Severe Septic Patients

A Phase 4 study testing Meropenem Injection in people with Sepsis, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The experimental and control group were used different administration of Meropenem through monitoring the Meropenem plasma concentration and clinical data Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sepsis
What is being tested?: Meropenem Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteChina
Study dates: 30 Jan 2018to 14 Dec 2019
Phase: Phase 4
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

Who may be able to join

Inpatients, whose informed consent has been obtained;
Clinical diagnosis of Sepsis

Who cannot join

Pregnancy or lactation;
Treated with other carbapenems;
Cannot be evaluated for efficacy and safety result from lack of clinical and laboratory parameter for Infection assessment;
Allergy to meropenem or other β-lactams, or the history of allergy;
Resistant to meropenem according to the antimicrobial susceptibility test;
Epilepsy or history of epilepsy;

Show all 14Show fewer

History of seizures;
Combined medicine with sodium valproate;
Combined medicine with anti-MRSA, anti-fungal drugs;
with severe liver or renal dysfunction;
Terminal cancer;
Septic shock;
APACH II ≥20;
Inappropriate to participate in the trial evaluated by investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Xinhua Hospital
Shanghai, Shanghai Municipality, 200092

Other trials in China

About this study

Official title: Efficacy and Pharmacokinetics of Meropenem in Different Administration for Patients With Severe Sepsis

The experimental and control group were used different administration of Meropenem through monitoring the Meropenem plasma concentration and clinical data

Read the detailed description

This study is a prospective, randomized controlled trial, which the subjects were severe sepstic patients for selecting Meropenem as antimicrobial drugs. The experimental and control group were used different administration of Meropenem through monitoring the Meropenem plasma concentration and clinical data, eventually demonstrate the effecacy and safety of Meropenem in patients with severe infection and optimize the best clinical practice for antimicrobial agents.

Conditions: Sepsis
Being tested: Meropenem Injection
Keywords: sepsis，meropenem，2 steps administration
Medical subject headings: Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Meropenem InjectionDrug
Also called meropenem,MEPEM
Different administration types between two groups

Study groups in NCT03645668
Study group	Role	What they receive
Experimental group	Experimental	meropenem injection, 1.0g, q8h,intravenous infusion ,0.5g/0.5h+0.5g/4h Receives: Drug: Meropenem Injection
Control group	Other	meropenem injection, 1.0g, q8h,continuous intravenous infusion duration ,1h Receives: Drug: Meropenem Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

T>MIC
Time above MIC% per administration interval
Measured: Day 1

Secondary outcomes (4)

APACHE II score
Change of Acute physiology and chronic health evaluation score (APACHE II score) during period of treatment
Measured: Day 0,Day 4,Day 8
SOFA
Change of Sepsis-related Organ Failure Assessment score (sofa) during period of treatment
Measured: Day 0,Day 4,Day 8
Mortality
Mortality within 28 days
Measured: Day 28
highest temperature
Variation of the highest temperature
Measured: Day 0,Day 4,Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 201814 Dec 2019

First posted24 Aug 2018
Study start30 Jan 2018
Primary completion14 Nov 2019
Study completion14 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SepsisStudies of the same condition, open and under way.
More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03645668
Sponsor's protocol ID: XH-18-003
Status last verified: Mar 2020
First submitted: 7 Feb 2018
Last updated: 13 Mar 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock

All Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Pharmacokinetics of Meropenem in Different Administration for Patients With Severe Sepsis
ClinicalTrials.gov ID: NCT03645668
Acronym / sponsor ID: XH-18-003
Conditions: Sepsis
Keywords: sepsis，meropenem，2 steps administration
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Study start: 30 Jan 2018 (actual)
Primary completion: 14 Nov 2019 (actual)
Study completion: 14 Dec 2019 (actual)
First posted: 24 Aug 2018 (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.

The experimental and control group were used different administration of Meropenem through monitoring the Meropenem plasma concentration and clinical data

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental group	Experimental	Drug: Meropenem Injectionmeropenem injection, 1.0g, q8h,intravenous infusion ,0.5g/0.5h+0.5g/4h
Control group	Other	Drug: Meropenem Injectionmeropenem injection, 1.0g, q8h,continuous intravenous infusion duration ,1h

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Inpatients, whose informed consent has been obtained;
Clinical diagnosis of Sepsis

Key exclusion criteria (14 listed)

Pregnancy or lactation;
Treated with other carbapenems;
Cannot be evaluated for efficacy and safety result from lack of clinical and laboratory parameter for Infection assessment;
Allergy to meropenem or other β-lactams, or the history of allergy;
Resistant to meropenem according to the antimicrobial susceptibility test;

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
Meropenem InjectionAlso: meropenem,MEPEMDifferent administration types between two groups	Drug	Control group, Experimental group

Primary outcome

T>MIC
Time frame: Day 1
Time above MIC% per administration interval

4 secondary outcomes

APACHE II score
Time frame: Day 0,Day 4,Day 8
SOFA
Time frame: Day 0,Day 4,Day 8
Mortality
Time frame: Day 28
highest temperature
Time frame: Day 0,Day 4,Day 8

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.

Related trials for Sepsis

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock

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.

Aihua FEI principal investigator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Meropenem Injection in people with Sepsis, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

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 2 inclusion and 14 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: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

T>MIC (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03645668.

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 13 Mar 2020.