<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04479189</url>
  </required_header>
  <id_info>
    <org_study_id>LAMP Assay</org_study_id>
    <nct_id>NCT04479189</nct_id>
  </id_info>
  <brief_title>LAMP Assay Versus PCR for Detection of blaNDM-1 and blaKPC Genes</brief_title>
  <official_title>LAMP Assay Versus PCR for Detection of blaNDM-1 and blaKPC Genes Among Carbapenem Resistant Gram Negative Isolates at Assiut University Hospitals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this work is Detection of gram-negative isolates from different clinical&#xD;
      samples,determination the antimicrobial susceptibility pattern of gram-negative isolates to&#xD;
      various antimicrobial agents, Molecular Detection of blaNDM-1 and blaKPC gene among&#xD;
      gram-negative isolates by PCR, Molecular Detection of blaNDM-1 and blaKPC gene among&#xD;
      gram-negative isolates by LAMPand,evaluation the use of the LAMP assay for rapid and cost&#xD;
      effective detection of the blaNDM-1 and blaKPC gene among gram-negative isolates in&#xD;
      comparison with PCR.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Carbapenem resistance in gram-negative bacteria has become a worldwide problem and has caused&#xD;
      a global epidemic that continues to grow..&#xD;
&#xD;
      New Delhi metallo-beta-lactamase 1 (NDM-1) enzyme that confers multi-drug resistance is&#xD;
      encoded by New Delhi metallo-beta-lactamase 1 gene (blaNDM-1)]. NDM-1inactivates major&#xD;
      classes of beta-lactam antibiotics including carbapenems by cleaving b-lactam rings. NDM-1was&#xD;
      reported in 11 different bacterial species including Escherichia coli, Klebsiella sp.,&#xD;
      Shigella boydii and Vibrio cholera indicating the potential of horizontal gene transfer.&#xD;
&#xD;
      Klebsiella pneumoniae carbapenemase (KPC) enzymes, belonging to class A (serine&#xD;
      carbapenemases) and inhibited by boronic acid, have rapidly become a global problem among the&#xD;
      Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter baumannii .&#xD;
&#xD;
      In infectious disease therapy, administration of adequate antimicrobial agents is essential&#xD;
      for preventing the emergence and spread of resistant bacteria. However, conventional&#xD;
      antimicrobial susceptibility testing (AST), based on bacterial growth, is time consuming;&#xD;
      therefore, a rapid, simple assay is needed for the timely selection of appropriate&#xD;
      antibiotics in clinical laboratories such as loop-mediated isothermal amplification (LAMP).&#xD;
&#xD;
      LAMP, developed by the Japanese researcher Notomi, is a novel gene amplification method that&#xD;
      can complete DNA amplification under isothermal conditions . LAMP is a strand displacement&#xD;
      amplification technique , which utilizes a set of 4 to 6 specially designed oligonucleotide&#xD;
      primers and a specific DNA polymerase (Bst). Via the process of strand displacement&#xD;
      amplification, a dumbbell DNA structure is produced which serves as a template for cycle&#xD;
      amplification. The lack of a need for a thermocycler, the speed of the reaction and make LAMP&#xD;
      a promising platform for the development of a simple and sensitive near-patient tool for the&#xD;
      molecular detection of genes in resource-limited settings.&#xD;
&#xD;
      LAMP is the most popular and well-established nucleic acid amplification technology among&#xD;
      alternatives for the polymerase chain reaction (PCR) . The steps of genetic testing include&#xD;
      nucleic acid extraction from the specimens, gene amplification, and detection. These steps&#xD;
      require considerable skill and expensive equipment and facilities, making convenient testing&#xD;
      at any given location difficult. To overcome these limitations, a new gene amplification&#xD;
      method, LAMP reaction, was developed which combines rapidity, simplicity, and high&#xD;
      specificity .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">October 2020</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <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</measure>
    <time_frame>during the procedure</time_frame>
    <description>Molecular Detection of blaNDM-1 and blaKPC gene among gram-negative isolates by PCR and LAMP</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Gene Amplification</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients infected by carbapenem resistant Gram negative bacteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients developing signs of infection on or after the third day of hospital admission&#xD;
             (Hospital associated infection)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients developing signs of infection before the third day of hospital admission&#xD;
             (community acquired infection)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Ayat Mohammed</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ayat Mohammed</last_name>
    <phone>01064642468</phone>
  </overall_contact>
  <overall_contact_backup>
    <last_name>.Shereen Mohammed</last_name>
    <email>Dr.ayat1200@aun.edu.eg</email>
  </overall_contact_backup>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 18, 2020</last_update_submitted>
  <last_update_submitted_qc>July 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ayat Hussein Mohammed</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04479189
org study id: LAMP Assay
nct id: NCT04479189
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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 .
observational model: Other
time perspective: Other
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
description: Molecular Detection of blaNDM-1 and blaKPC gene among gram-negative isolates by PCR and LAMP
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Ayat Mohammed
role: Principal Investigator
affiliation: Assiut University
last name: Ayat Mohammed
phone: 01064642468
last name: .Shereen Mohammed
email: Dr.ayat1200@aun.edu.eg
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ayat Hussein Mohammed
investigator title: Principal Investigator