NCT04479189

Brief Summary

The aim of this work is Detection of gram-negative isolates from different clinical samples,determination the antimicrobial susceptibility pattern of gram-negative isolates to various antimicrobial agents, Molecular Detection of blaNDM-1 and blaKPC gene among gram-negative isolates by PCR, Molecular Detection of blaNDM-1 and blaKPC gene among gram-negative isolates by LAMPand,evaluation the use of the LAMP assay for rapid and cost effective detection of the blaNDM-1 and blaKPC gene among gram-negative isolates in comparison with PCR.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

July 15, 2020

Last Update Submit

July 18, 2020

Conditions

Gene Amplification

Outcome Measures

Primary Outcomes (1)

  • evaluate the use of the LAMP assay for rapid and cost effective detection of the blaNDM-1 and blaKPC gene among gram-negative isolates in comparison with PCR

    Molecular Detection of blaNDM-1 and blaKPC gene among gram-negative isolates by PCR and LAMP

    during the procedure

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients infected by carbapenem resistant Gram negative bacteria

You may qualify if:

  • Patients developing signs of infection on or after the third day of hospital admission (Hospital associated infection)

You may not qualify if:

  • Patients developing signs of infection before the third day of hospital admission (community acquired infection)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ayat Mohammed

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayat Mohammed

CONTACT

01064642468

.Shereen Mohammed

CONTACT

Dr.ayat1200@aun.edu.eg

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 15, 2020

First Posted

July 21, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2022

Study Completion

October 1, 2023

Last Updated

July 21, 2020

Record last verified: 2020-07