NCT04679610

Brief Summary

Infections caused by resistant gram-negative bacteria are becoming increasingly prevalent and now constitute a serious threat to public health worldwide because they are difficult to treat and are associated with high morbidity and mortality rates. Among nosocomial infections, the most major threat represent infections caused by multidrug-resistant (MDR) and extensively drug-resistant (XDR) Gram-negative pathogens.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

3.2 years

First QC Date

December 8, 2020

Last Update Submit

December 16, 2020

Conditions

Nosocomial Infection

Keywords

ceftolozane-tazobactam, antibiotics, gram "-" bacteria, ESBL

Outcome Measures

Primary Outcomes (6)

  • To access ceftolozane-tazobactam activity against many multidrug-resistant isolates of P. aeruginosa,

    ceftolozane-tazobactam will demonstrate activity against many multidrug-resistant isolates of P. aeruginosa, including cephalosporin- and carbapenem-resistant isolates that do not produce a metallo-beta-lactamase

    01.01.2017 - 31.10.2018

  • To access ceftolozane-tazobactam activity against P. aeruginosa producing class A ESBL

    ceftolozane-tazobactam will demonstrate activity against P. aeruginosa isolates producing class A extended-spectrum beta-lactamases (ESBLs) and carbapenemases of GES type

    01.01.2017 - 31.10.2018

  • To access ceftolozane-tazobactam activity against P. aeruginosa

    ceftolozane-tazobactam will demonstrate activity against P. aeruginosa isolates of various genotypes including members of international high-risk clones

    01.01.2017 - 31.10.2018

  • To determine the prevalence of Enterobacteriaceae producing extended-spectrum beta-lactamases (ESBLs) of molecular class A

    the prevalence of Enterobacteriaceae producing extended-spectrum beta-lactamases (ESBLs) of molecular class A will be high

    01.01.2017 - 31.10.2018

  • To determine the molecular class D (OXA-48-like) enzymes carbapenemases in Enterobacteriaceae in Russia and the prevalence of carbapenemases of molecular classes A and B

    molecular class D (OXA-48-like) enzymes will be the most common carbapenemases in Enterobacteriaceae in Russia and the prevalence of carbapenemases of molecular classes A and B will be limited

    01.01.2017 - 31.10.2018

  • To access ceftolozane-tazobactam activity against many Eterobacteriaceae isolates produsing ESBLs and/or OXA-48-like enzymes

    ceftolozane-tazobactam will demonstrate activity againt many Eterobacteriaceae isolates produsing ESBLs and/or OXA-48-like enzymes

    01.01.2017 - 31.10.2018

Eligibility Criteria

AgeUp to 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with gram-negative clinical isolates collected from patients with intraabdominal, urinary tract, lower respiratory tract, and bloodstream nosocomial infections

You may qualify if:

  • consecutive, non-duplicate (one per patient/episode of infection), gram-negative clinical isolates collected from patients with intra-abdominal, urinary tract, lower respiratory tract, and bloodstream nosocomial infections

You may not qualify if:

  • Non-Enterobacteriaceae isolates after reidentification

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy

Smolensk, 214019, Russia

Location

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2020

First Posted

December 22, 2020

Study Start

February 1, 2017

Primary Completion

April 1, 2020

Study Completion

December 1, 2020

Last Updated

December 22, 2020

Record last verified: 2020-12

Locations

RU(1)