<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/NCT03266341</url>
  </required_header>
  <id_info>
    <org_study_id>Anaerobes detection in samples</org_study_id>
    <nct_id>NCT03266341</nct_id>
  </id_info>
  <brief_title>Detection of Anaerobes in Different Clinicalsamples</brief_title>
  <official_title>Detection of Anaerobes in Different Clinical Samples</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>
      Early detection of anaerobic bacteria to avoid its serious comlications&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Infections caused by anaerobic bacteria are common and may be serious and&#xD;
      life-threatening.Obligately anaerobic bacteria do not grow on solid media in room air (0.04%&#xD;
      carbon dioxide and 21% oxygen); facultatively anaerobic bacteria can grow in the presence or&#xD;
      absence of air. Microaerophilic bacteria do not grow at all aerobically or grow poorly, but&#xD;
      grow better under 10% carbon dioxide or anaerobically. Anaerobic bacteria can be divided into&#xD;
      strict anaerobes that can not grow in the presence of more than 0.5% oxygen and moderate&#xD;
      anaerobic bacteria that are able of growing between 2 and 8% oxygen. Anaerobic bacteria&#xD;
      usually do not possess catalase, but some can generate superoxide dismutase which protects&#xD;
      them from oxygen.&#xD;
&#xD;
      Anaerobes are the predominant components of the bacterial flora of normal human skin and&#xD;
      mucous membranes, and are therefore a common cause of bacterial infections of endogenous&#xD;
      origin. Infections due to anaerobic bacteria can evolve all body systems and sites . The&#xD;
      predominant ones include: abdominal, pelvic, respiratory, and skin and soft tissues&#xD;
      infections. Because of their fastidious nature, they are difficult to isolate from infectious&#xD;
      sites and are often overlooked. Failure to direct therapy against these organisms often leads&#xD;
      to clinical failures. Their isolation requires appropriate methods of collection,&#xD;
      transportation, and cultivation of specimens. Treatment of anaerobic bacterial infection is&#xD;
      complicated by the slow growth of these organisms, which makes diagnosis in the laboratory&#xD;
      possible only after several days, by their often polymicrobial nature and by the growing&#xD;
      resistance of anaerobic bacteria to antimicrobial agent.&#xD;
&#xD;
      Almost all anaerobic infections originate from the patient's own microflora. Poor blood&#xD;
      supply and tissue necrosis lower the oxidation-reduction potential and favor the growth of&#xD;
      anaerobes. Any condition that lowers the blood supply to an affected area can predispose to&#xD;
      anaerobic infection. Therefore, foreign body, malignancy, surgery, edema, shock, traum and&#xD;
      vascular disease may predispose to anaerobic infection. Previous infection with aerobic or&#xD;
      facultative organisms also may make the local tissue conditions more favorable for the growth&#xD;
      of anaerobic organisms. The human defense mechanisms also may be impaired by anaerobic&#xD;
      conditions .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 15, 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Detection of anaerobes in different clinical samples</measure>
    <time_frame>2years</time_frame>
    <description>Samples will be in oculated on different anaerobic media</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Anaerobic Bacterial Infection</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Cultures</intervention_name>
    <description>Take different samples anddetection of anaerobes on enriched blood agar and other selective anaerobic cultures</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Take different samples for dtection of the causitive anaerobe&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patient with infection organism not yet detected&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with infection organism is already detected&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sohair Mohamed ahmed, Proffisor</last_name>
    <role>Study Director</role>
    <affiliation>Proffisor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Asmaa Omar ahmef, Assistant prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant pro</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Safaa Ali samir hussien mohamed, Master</last_name>
    <phone>01018612254</phone>
    <email>Safaa.samir191@gmail.com</email>
  </overall_contact>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Safaa Samir</investigator_full_name>
    <investigator_title>Detection of anaerobes in different clinical samples</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacterial Infections</mesh_term>
  </condition_browse>
  <!-- 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/NCT03266341
org study id: Anaerobes detection in samples
nct id: NCT03266341
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Early detection of anaerobic bacteria to avoid its serious comlications
Infections caused by anaerobic bacteria are common and may be serious and
      life-threatening.Obligately anaerobic bacteria do not grow on solid media in room air (0.04%
      carbon dioxide and 21% oxygen); facultatively anaerobic bacteria can grow in the presence or
      absence of air. Microaerophilic bacteria do not grow at all aerobically or grow poorly, but
      grow better under 10% carbon dioxide or anaerobically. Anaerobic bacteria can be divided into
      strict anaerobes that can not grow in the presence of more than 0.5% oxygen and moderate
      anaerobic bacteria that are able of growing between 2 and 8% oxygen. Anaerobic bacteria
      usually do not possess catalase, but some can generate superoxide dismutase which protects
      them from oxygen.

      Anaerobes are the predominant components of the bacterial flora of normal human skin and
      mucous membranes, and are therefore a common cause of bacterial infections of endogenous
      origin. Infections due to anaerobic bacteria can evolve all body systems and sites . The
      predominant ones include: abdominal, pelvic, respiratory, and skin and soft tissues
      infections. Because of their fastidious nature, they are difficult to isolate from infectious
      sites and are often overlooked. Failure to direct therapy against these organisms often leads
      to clinical failures. Their isolation requires appropriate methods of collection,
      transportation, and cultivation of specimens. Treatment of anaerobic bacterial infection is
      complicated by the slow growth of these organisms, which makes diagnosis in the laboratory
      possible only after several days, by their often polymicrobial nature and by the growing
      resistance of anaerobic bacteria to antimicrobial agent.

      Almost all anaerobic infections originate from the patient's own microflora. Poor blood
      supply and tissue necrosis lower the oxidation-reduction potential and favor the growth of
      anaerobes. Any condition that lowers the blood supply to an affected area can predispose to
      anaerobic infection. Therefore, foreign body, malignancy, surgery, edema, shock, traum and
      vascular disease may predispose to anaerobic infection. Previous infection with aerobic or
      facultative organisms also may make the local tissue conditions more favorable for the growth
      of anaerobic organisms. The human defense mechanisms also may be impaired by anaerobic
      conditions .
observational model: Case-Only
time perspective: Prospective
measure: Detection of anaerobes in different clinical samples
time frame: 2years
description: Samples will be in oculated on different anaerobic media
intervention type: Diagnostic Test
intervention name: Cultures
description: Take different samples anddetection of anaerobes on enriched blood agar and other selective anaerobic cultures
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Sohair Mohamed ahmed, Proffisor
role: Study Director
affiliation: Proffisor
last name: Asmaa Omar ahmef, Assistant prof
role: Principal Investigator
affiliation: Assistant pro
last name: Safaa Ali samir hussien mohamed, Master
phone: 01018612254
email: Safaa.samir191@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Safaa Samir
investigator title: Detection of anaerobes in different clinical samples
mesh term: Bacterial Infections