Amplification and Selection of Antimicrobial Resistance i... | NCT03140826

Studies
Amplification and Selection of Antimicrobial Resistance in the Intestine II

NCT03140826

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Aug 3, 2020Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Antibiotic Selection Pressure

Interventions

meropenem

Countries

Germany

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2018Actual

Primary Completion Date

Jul 31, 2020Actual

Completion Date

Jul 31, 2020Actual

First Submitted Date

May 2, 2017

First Submission Date that Met QC Criteria

May 2, 2017

First Posted Date

May 4, 2017Actual

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

Jul 30, 2020

Last Update Posted Date

Aug 3, 2020Actual

Name	Class
University Hospital of Cologne	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Stool samples will be collected from two groups of neutropenic patients in the case that a therapy with either meropenem or piperacillin/tazobactam is needed due to a suspected infection. The intestinal resistome will be determined and quantified using shotgun metagenomics. Based on this, regression models will be used to determine the actual selection pressure caused by these drugs, and both selective forces will be compared. The results will reveal if there is a drug that causes a lower selection pressure compared to the other. The study aims to generate knowledge that is required to design effective antibiotic stewardship programs.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Meropenem arm		Patients receiving meropenem to treat an infection.	Drug: meropenem
Pip-Tazo arm		Patients receiving piperacillin-meropenem to treat an infection.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
meropenem	Drug	Antibiotics to treat infections.	Meropenem arm	piperacillin-tazobactam

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Antibiotic Selection Pressure	Degree of the change of the intestinal resistome.	under treatment, max. 10 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with hemato-oncological disease in neutropenia or with expected neutropenia
Need for treatment with meropenem or piperacillin-tazobactam

Exclusion Criteria:

pregnancy
HIV, HBV, HCV

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

Patients with hemato-oncological disease in neutropenia or with expected neutropenia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthias Willmann, Prof. Dr.	University Tuebingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Cologne		Cologne		50935	Germany
Institute of Medical Microbiology and Hygiene, University Hospital of Tuebingen

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

Intervention Browse Module

MeSH Terms

ID	Term
D000077731	Meropenem
D000077725	Piperacillin, Tazobactam Drug Combination

Ancestor Terms

ID	Term
D013845	Thienamycins
D015780	Carbapenems
D047090	beta-Lactams
D007769	Lactams
D000577

Browse Leaves

Not provided

Browse Branches

Not provided