- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04479189
LAMP Assay Versus PCR for Detection of blaNDM-1 and blaKPC Genes
LAMP Assay Versus PCR for Detection of blaNDM-1 and blaKPC Genes Among Carbapenem Resistant Gram Negative Isolates at Assiut University Hospitals
Study Overview
Status
Conditions
Detailed Description
Carbapenem resistance in gram-negative bacteria has become a worldwide problem and has caused a global epidemic that continues to grow..
New Delhi metallo-beta-lactamase 1 (NDM-1) enzyme that confers multi-drug resistance is encoded by New Delhi metallo-beta-lactamase 1 gene (blaNDM-1)]. NDM-1inactivates major classes of beta-lactam antibiotics including carbapenems by cleaving b-lactam rings. NDM-1was reported in 11 different bacterial species including Escherichia coli, Klebsiella sp., Shigella boydii and Vibrio cholera indicating the potential of horizontal gene transfer.
Klebsiella pneumoniae carbapenemase (KPC) enzymes, belonging to class A (serine carbapenemases) and inhibited by boronic acid, have rapidly become a global problem among the Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter baumannii .
In infectious disease therapy, administration of adequate antimicrobial agents is essential for preventing the emergence and spread of resistant bacteria. However, conventional antimicrobial susceptibility testing (AST), based on bacterial growth, is time consuming; therefore, a rapid, simple assay is needed for the timely selection of appropriate antibiotics in clinical laboratories such as loop-mediated isothermal amplification (LAMP).
LAMP, developed by the Japanese researcher Notomi, is a novel gene amplification method that can complete DNA amplification under isothermal conditions . LAMP is a strand displacement amplification technique , which utilizes a set of 4 to 6 specially designed oligonucleotide primers and a specific DNA polymerase (Bst). Via the process of strand displacement amplification, a dumbbell DNA structure is produced which serves as a template for cycle amplification. The lack of a need for a thermocycler, the speed of the reaction and make LAMP a promising platform for the development of a simple and sensitive near-patient tool for the molecular detection of genes in resource-limited settings.
LAMP is the most popular and well-established nucleic acid amplification technology among alternatives for the polymerase chain reaction (PCR) . The steps of genetic testing include nucleic acid extraction from the specimens, gene amplification, and detection. These steps require considerable skill and expensive equipment and facilities, making convenient testing at any given location difficult. To overcome these limitations, a new gene amplification method, LAMP reaction, was developed which combines rapidity, simplicity, and high specificity .
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ayat Mohammed
- Phone Number: 01064642468
Study Contact Backup
- Name: .Shereen Mohammed
- Email: Dr.ayat1200@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients developing signs of infection on or after the third day of hospital admission (Hospital associated infection)
Exclusion Criteria:
- Patients developing signs of infection before the third day of hospital admission (community acquired infection)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: during the procedure
|
Molecular Detection of blaNDM-1 and blaKPC gene among gram-negative isolates by PCR and LAMP
|
during the procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayat Mohammed, Assiut University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LAMP Assay
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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