Gene AmplificationNCT04479189
LAMP Assay Versus PCR for Detection of blaNDM-1 and blaKPC Genes
An observational study of Gene Amplification, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gene Amplification
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients infected by carbapenem resistant Gram negative bacteria
Who may be able to join
- Patients developing signs of infection on or after the third day of hospital admission (Hospital associated infection)
Who cannot join
- Patients developing signs of infection before the third day of hospital admission (community acquired infection)
Trial locations and contacts
No sites are listed yet.
Ayat Mohammed contact
.Shereen Mohammed contact
About this study
Official title: LAMP Assay Versus PCR for Detection of blaNDM-1 and blaKPC Genes Among Carbapenem Resistant Gram Negative Isolates at Assiut University Hospitals
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.
Read the 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 .
- Conditions
- Gene Amplification
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study startOct 2020 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gene AmplificationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayat Hussein Mohammed, Assiut University
- Investigators
- Ayat Mohammed, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479189
- Sponsor's protocol ID
- LAMP Assay
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LAMP Assay Versus PCR for Detection of blaNDM-1 and blaKPC Genes Among Carbapenem Resistant Gram Negative Isolates at Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT04479189
- Acronym / sponsor ID
- LAMP Assay
- Conditions
- Gene Amplification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients infected by carbapenem resistant Gram negative bacteria
Key inclusion criteria (1 listed)
- Patients developing signs of infection on or after the third day of hospital admission (Hospital associated infection)
Key exclusion criteria (1 listed)
- Patients developing signs of infection before the third day of hospital admission (community acquired infection)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayat Mohammed contact
.Shereen Mohammed contact
Ayat Mohammed principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Gene Amplification, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayat Mohammed (01064642468), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.