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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02420366
Date of registration:	08/04/2015
Prospective Registration:	No
Primary sponsor:	Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Public title:	Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae
Scientific title:	Multi-center, Retrospective Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae
Date of first enrolment:	May 2014
Target sample size:	257
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02420366
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Greece	Italy	United Kingdom	United States

Contacts

Name:	Karen Fusaro
Address:
Telephone:
Email:
Affiliation:	Sponsor GmbH

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female =18 years of age.

- Carbapenem resistant Enterobacteriaceae (CRE) must be identified in the urine, blood
or respiratory tract samples submitted for culture in the setting of cUTI or AP, HABP,
VABP, and/or bacteremia.

- Diagnosis with either cUTI or AP, HABP, VABP, and/or bacteremia.

Exclusion Criteria:

- none

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Bacteremia

Urinary Tract Infection, Complicated

Acute Pyelonephritis

Hospital Acquired Bacterial Pneumonia

Ventilator-associated Bacterial Pneumonia

Intervention(s)

Primary Outcome(s)

Prevalence of positive CRE infections (specifically cUTI, AP, HABP, VABP, Bacteremia) in a target patient population [Time Frame: 6 month period from September 1, 2013 to March 1, 2014]

Secondary Outcome(s)

Secondary ID(s)

Rempex 506 NH

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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