Approach for Optimizing Meropenem Therapy in Intubated an... | NCT03915236

Studies
Approach for Optimizing Meropenem Therapy in Intubated and Mechanically-Ventilated, Adult Patients With Severe Gram-Negative Lower Respiratory Tract Infection

NCT03915236

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status

Terminated

Last Update Posted

Feb 17, 2020Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Lower Respiratory Tract Infection

Interventions

MON4STRAT Strategy
Control group

Countries

Belgium
France
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2018-000450-21	EudraCT Number

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

It was decided to discontinuate the study due to a very low recruitment.

Expanded Access Info

Start Date

Feb 18, 2019Actual

Primary Completion Date

Jul 8, 2019Actual

Completion Date

Jul 29, 2019Actual

First Submitted Date

Apr 3, 2019

First Submission Date that Met QC Criteria

Apr 12, 2019

First Posted Date

Apr 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2020

Last Update Posted Date

Feb 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Antibacterial drugs are facing increasing limitations in terms of effectiveness due to emergence resistance. Improved antibacterial drug monitoring approaches are particularly needed in nosocomial infections occurring in ICU patients, including ventilator-associated pneumonia and ventilator-associated tracheobronchitis, where decreased susceptibility of the etiological organisms is observed worldwide and pharmacokinetic alterations frequently observed.

No routine drug monitoring is available for betalactams at the point of care in a useful time frame (i.e., within a few hours after having collected the blood specimens).

The purpose of this study is to compare MON4STRAT approach for reaching and maintaining a meropenem pre-determined PK-PD target when compared to conventional meropenem dose.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: MON4STRAT Strategy	Experimental		Device: MON4STRAT Strategy
Group 2: Conventional treatment	Active Comparator		Other: Control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MON4STRAT Strategy	Device	Meropenem infusion guided by daily Therapeutic Drug Monitoring (adjusted in order to reach predetermined PK/PD targets) using MON4STRAT device.	Group 1: MON4STRAT Strategy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To document the superiority of the MON4STRAT approach for reaching and maintaining a meropenem pre-determined PK-PD target when compared to conventional therapies.	The proportion of time from day 1 after randomization to end of therapy (EOT) in which the free meropenem trough concentration in serum was maintained above 8 mg/L or above 4 x MIC if antibiotic MIC > 2 and ≤ 8 mg/L, without exceeding 140 mg/L at peak level, as determined by a method of reference (HPLC).	During meropenem treatment: Day1 to Day 7

Secondary Outcomes

Measure	Description	Time Frame
Clinical and microbiological response rates		Test of cure (TOC) visit (7 to 10 days after last study drug infusion)
Time to LRT bacterial eradication, as assessed by follow-up cultures of ETA		Days 3, 5, 7 of treatment and at the end of treatment (EOT) visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and non-pregnant, non-lactating females, 18 years of age or older
Currently intubated and mechanically-ventilated subjects in the ICU
Suspicion of lower respiratory tract infection
Presence of Gram-negative organism(s) by Gram stain OR by culture of pre-therapy respiratory specimen (eg, endotracheal aspirate [ETA], bronchoalveolar lavage [BAL], or mini-BAL) OR previous colonization 48 h before screening.
Initial empiric antimicrobial meropenem regimen
At least two risk factors for multidrug-resistant organisms
Provision of written informed consent by the subject or a family member or a close relative or waiver of consent.

Exclusion Criteria:

Subjects who have received antibiotic therapy for Gram-negative LRT infection for ≥ 36 hours at the time of randomization
Subjects with known or suspected type 1 hypersensitivity to beta-lactam and/or cephalosporin
Subjects taking valproic acid for a seizure disorder
Subjects who have had a left hemisphere stroke within five days and there is an increased risk of fatal brain oedema
Subjects who have cystic fibrosis, human immunodeficiency virus (HIV) infection with CD4 count <100 cell/mm3 or invasive fungal infection of the lung
Neutropenia (ANC < 103 neutrophils/mm3)
Bone marrow transplant.
Subjects who have been on mechanical ventilation for >28 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Université Libre de Bruxelles		Brussels			Belgium
Pitié Salpêtrière Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design
D008722	Methods