<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/NCT04493008</url>
  </required_header>
  <id_info>
    <org_study_id>PUB 2123001</org_study_id>
    <nct_id>NCT04493008</nct_id>
  </id_info>
  <brief_title>Antibiotic Usage and Resistance; Knowledge and Practices Before and After Educational Sessions</brief_title>
  <official_title>Antibiotic Usage and Resistance - A Survey on Knowledge and Practices Among Second Year Dental Students and Patients Attending Misr International University Dental Clinics Before and After Educational Sessions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Misr International University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Misr International 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 inappropriate use of antibiotics by patients not only increases the growth of resistant&#xD;
      bacterial strains but also, may lead to adverse side effects that range from gastrointestinal&#xD;
      disturbances to fatal anaphylactic shock. To meet the challenges faced by the spread of&#xD;
      antibiotics resistance, different approaches have been taken worldwide. One of the approaches&#xD;
      which are commonly proposed is to engage instructional and educational campaigns among the&#xD;
      health care personnel and the general population about antibiotic resistance and its&#xD;
      dangerous consequences.The present study aims at assessing the knowledge, practices of&#xD;
      antibiotic uses and resistance before and after educational sessions among second year dental&#xD;
      students and a group of patients attending MIU Dental Clinics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Statement of problem: Dental students' and patients' knowledge about antibiotic uses are&#xD;
      essential for overcoming antibiotic resistance. Antibiotic resistance is considered an&#xD;
      important global public health problem and is recognized as a major cause of the emerging&#xD;
      problem of antimicrobial agent resistance. The inappropriate use of antibiotics by patients&#xD;
      not only increases the growth of resistant bacterial strains but also, may lead to adverse&#xD;
      side effects that range from gastrointestinal disturbances to fatal anaphylactic shock. To&#xD;
      meet the challenges faced by the spread of antibiotics resistance, different approaches have&#xD;
      been taken worldwide. One of the approaches which are commonly proposed is to engage&#xD;
      instructional and educational campaigns among the health care personnel and the general&#xD;
      population about antibiotic resistance and its dangerous consequences.&#xD;
&#xD;
      Aim of the study: The present study aims at assessing the knowledge, practices of antibiotic&#xD;
      uses and resistance before and after educational sessions among second year dental students&#xD;
      and a group of patients attending MIU Dental Clinics.&#xD;
&#xD;
      Materials and Methods: The study will be conducted on (315) second year dental students&#xD;
      through a pre-and post-educational sessions questionnaire. Students will receive training&#xD;
      sessions for four hours during their dental public health course given by senior staff&#xD;
      members before conducting educational sessions targeting patients attending MIU Dental&#xD;
      Clinics. Educational sessions will include verbal and visual tools.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single group will be assessed before and after an educational session</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge about antibiotics</measure>
    <time_frame>4 months</time_frame>
    <description>Percentage of correct answers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Awareness level</measure>
    <time_frame>4 months</time_frame>
    <description>Percentage</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">310</enrollment>
  <condition>Antibiotics</condition>
  <arm_group>
    <arm_group_label>MIU students and patents</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Educational session</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Experimental: Educational session</intervention_name>
    <description>Each patient will receive educational session consisting of face-to-face interview, administration of posters, brochures and pamphlets.</description>
    <arm_group_label>MIU students and patents</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Second year dental students at MIU during the Academic Year 2017/2018. Any patient&#xD;
             over 18 years old attending the MIU Dental clinics, and agreeing to sign an informed&#xD;
             consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with mental disorders, deaf, and blind patients will be excluded from the&#xD;
             study because the educational sessions will include verbal and visual tools.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahassen M Farghaly, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Vice president of community services and environmental awareness</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Oral &amp; Dental Medicine</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Cope AL, Wood F, Francis NA, Chestnutt IG. General dental practitioners' perceptions of antimicrobial use and resistance: a qualitative interview study. Br Dent J. 2014 Sep;217(5):E9. doi: 10.1038/sj.bdj.2014.761.</citation>
    <PMID>25213543</PMID>
  </reference>
  <reference>
    <citation>Mahajan, Dr. Manali. (2014). A Questionnaire based Survey on the Knowledge, Attitude and Practises about Antimicrobial Resistance and Usage among the Second year MBBS Students of a Teaching tertiary care Hospital in Central India. International Journal of Pharmacological Research.</citation>
  </reference>
  <reference>
    <citation>Tulip DE, Palmer NO. A retrospective investigation of the clinical management of patients attending an out of hours dental clinic in Merseyside under the new NHS dental contract. Br Dent J. 2008 Dec 20;205(12):659-64; discussion 648. doi: 10.1038/sj.bdj.2008.1044. Epub 2008 Dec 5.</citation>
    <PMID>19057559</PMID>
  </reference>
  <reference>
    <citation>Dailey YM, Martin MV. Are antibiotics being used appropriately for emergency dental treatment? Br Dent J. 2001 Oct 13;191(7):391-3. doi: 10.1038/sj.bdj.4801190.</citation>
    <PMID>11697600</PMID>
  </reference>
  <reference>
    <citation>Sweeney LC, Dave J, Chambers PA, Heritage J. Antibiotic resistance in general dental practice--a cause for concern? J Antimicrob Chemother. 2004 Apr;53(4):567-76. doi: 10.1093/jac/dkh137. Epub 2004 Feb 25.</citation>
    <PMID>14985274</PMID>
  </reference>
  <reference>
    <citation>Abu-Mostafa NA, Al-Mejlad NJ, Al-Yami AS, Al-Sakhin FZ, Al-Mudhi SA. A survey of awareness related to the use of antibiotics for dental issues among non-medical female university students in Riyadh, Saudi Arabia. J Infect Public Health. 2017 Nov-Dec;10(6):842-848. doi: 10.1016/j.jiph.2017.01.015. Epub 2017 Feb 21.</citation>
    <PMID>28233723</PMID>
  </reference>
  <reference>
    <citation>Metlay JP, Stafford RS, Singer DE. National trends in the use of antibiotics by primary care physicians for adult patients with cough. Arch Intern Med. 1998 Sep 14;158(16):1813-8. doi: 10.1001/archinte.158.16.1813.</citation>
    <PMID>9738612</PMID>
  </reference>
  <reference>
    <citation>McManus P, Hammond ML, Whicker SD, Primrose JG, Mant A, Fairall SR. Antibiotic use in the Australian community, 1990-1995. Med J Aust. 1997 Aug 4;167(3):124-7. doi: 10.5694/j.1326-5377.1997.tb138809.x.</citation>
    <PMID>9269265</PMID>
  </reference>
  <reference>
    <citation>Butler CC, Rollnick S, Pill R, Maggs-Rapport F, Stott N. Understanding the culture of prescribing: qualitative study of general practitioners' and patients' perceptions of antibiotics for sore throats. BMJ. 1998 Sep 5;317(7159):637-42. doi: 10.1136/bmj.317.7159.637.</citation>
    <PMID>9727992</PMID>
  </reference>
  <reference>
    <citation>Annual report of the chief medical officer, volume two, 2011. Infections and the rise of antimicrobial resistance.</citation>
  </reference>
  <reference>
    <citation>WHO Library Cataloguing-in-Publication Data. Antibiotic resistance: Multi-country public awareness survey .World Health Organization. 2015.</citation>
  </reference>
  <reference>
    <citation>Lewis MA. Why we must reduce dental prescription of antibiotics: European Union Antibiotic Awareness Day. Br Dent J. 2008 Nov 22;205(10):537-8. doi: 10.1038/sj.bdj.2008.984.</citation>
    <PMID>19023306</PMID>
  </reference>
  <reference>
    <citation>Wise R, Hart T, Cars O, Streulens M, Helmuth R, Huovinen P, Sprenger M. Antimicrobial resistance. Is a major threat to public health. BMJ. 1998 Sep 5;317(7159):609-10. doi: 10.1136/bmj.317.7159.609. No abstract available.</citation>
    <PMID>9727981</PMID>
  </reference>
  <reference>
    <citation>Aljadhey H, Assiri GA, Mahmoud MA, Al-Aqeel S, Murray M. Self-medication in Central Saudi Arabia. Community pharmacy consumers' perspectives. Saudi Med J. 2015 Mar;36(3):328-34. doi: 10.15537/smj.2015.3.10523.</citation>
    <PMID>25737176</PMID>
  </reference>
  <reference>
    <citation>Khan A K A, Banu G, K K R. Antibiotic Resistance and Usage-A Survey on the Knowledge, Attitude, Perceptions and Practices among the Medical Students of a Southern Indian Teaching Hospital. J Clin Diagn Res. 2013 Aug;7(8):1613-6. doi: 10.7860/JCDR/2013/6290.3230. Epub 2013 Jul 1.</citation>
    <PMID>24086854</PMID>
  </reference>
  <reference>
    <citation>Chen C, Chen YM, Hwang KL, Lin SJ, Yang CC, Tsay RW, Liu CE, Young TG. Behavior, attitudes and knowledge about antibiotic usage among residents of Changhua, Taiwan. J Microbiol Immunol Infect. 2005 Feb;38(1):53-9.</citation>
    <PMID>15692628</PMID>
  </reference>
  <reference>
    <citation>Srinivasan A, Song X, Richards A, Sinkowitz-Cochran R, Cardo D, Rand C. A survey of knowledge, attitudes, and beliefs of house staff physicians from various specialties concerning antimicrobial use and resistance. Arch Intern Med. 2004 Jul 12;164(13):1451-6. doi: 10.1001/archinte.164.13.1451.</citation>
    <PMID>15249355</PMID>
  </reference>
  <reference>
    <citation>Vanden Eng J, Marcus R, Hadler JL, Imhoff B, Vugia DJ, Cieslak PR, Zell E, Deneen V, McCombs KG, Zansky SM, Hawkins MA, Besser RE. Consumer attitudes and use of antibiotics. Emerg Infect Dis. 2003 Sep;9(9):1128-35. doi: 10.3201/eid0909.020591.</citation>
    <PMID>14519251</PMID>
  </reference>
  <reference>
    <citation>Azevedo MM, Pinheiro C, Yaphe J, Baltazar F. Portuguese students' knowledge of antibiotics: a cross-sectional study of secondary school and university students in Braga. BMC Public Health. 2009 Sep 23;9:359. doi: 10.1186/1471-2458-9-359.</citation>
    <PMID>19775451</PMID>
  </reference>
  <reference>
    <citation>Simpson SA, Wood F, Butler CC. General practitioners' perceptions of antimicrobial resistance: a qualitative study. J Antimicrob Chemother. 2007 Feb;59(2):292-6. doi: 10.1093/jac/dkl467. Epub 2006 Nov 16.</citation>
    <PMID>17110392</PMID>
  </reference>
  <reference>
    <citation>Wright EP, Jain P. Survey of antibiotic knowledge amongst final year medical students. J Antimicrob Chemother. 2004 Mar;53(3):550-1. doi: 10.1093/jac/dkh096. Epub 2004 Feb 4. No abstract available.</citation>
    <PMID>14762052</PMID>
  </reference>
  <reference>
    <citation>Andre M, Vernby A, Berg J, Lundborg CS. A survey of public knowledge and awareness related to antibiotic use and resistance in Sweden. J Antimicrob Chemother. 2010 Jun;65(6):1292-6. doi: 10.1093/jac/dkq104. Epub 2010 Apr 1.</citation>
    <PMID>20360063</PMID>
  </reference>
  <reference>
    <citation>Armitage, P., Berry, G., &amp; Matthews, J. N. S. Statistical methods in medical research. Wiley Online Library,4rth edition, 2008</citation>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Antibiotic resistance</keyword>
  <keyword>Antibiotic uses</keyword>
  <keyword>Knowledge about antibiotics</keyword>
  <keyword>dental students</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04493008
org study id: PUB 2123001
nct id: NCT04493008
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The inappropriate use of antibiotics by patients not only increases the growth of resistant
      bacterial strains but also, may lead to adverse side effects that range from gastrointestinal
      disturbances to fatal anaphylactic shock. To meet the challenges faced by the spread of
      antibiotics resistance, different approaches have been taken worldwide. One of the approaches
      which are commonly proposed is to engage instructional and educational campaigns among the
      health care personnel and the general population about antibiotic resistance and its
      dangerous consequences.The present study aims at assessing the knowledge, practices of
      antibiotic uses and resistance before and after educational sessions among second year dental
      students and a group of patients attending MIU Dental Clinics.
Statement of problem: Dental students' and patients' knowledge about antibiotic uses are
      essential for overcoming antibiotic resistance. Antibiotic resistance is considered an
      important global public health problem and is recognized as a major cause of the emerging
      problem of antimicrobial agent resistance. The inappropriate use of antibiotics by patients
      not only increases the growth of resistant bacterial strains but also, may lead to adverse
      side effects that range from gastrointestinal disturbances to fatal anaphylactic shock. To
      meet the challenges faced by the spread of antibiotics resistance, different approaches have
      been taken worldwide. One of the approaches which are commonly proposed is to engage
      instructional and educational campaigns among the health care personnel and the general
      population about antibiotic resistance and its dangerous consequences.

      Aim of the study: The present study aims at assessing the knowledge, practices of antibiotic
      uses and resistance before and after educational sessions among second year dental students
      and a group of patients attending MIU Dental Clinics.

      Materials and Methods: The study will be conducted on (315) second year dental students
      through a pre-and post-educational sessions questionnaire. Students will receive training
      sessions for four hours during their dental public health course given by senior staff
      members before conducting educational sessions targeting patients attending MIU Dental
      Clinics. Educational sessions will include verbal and visual tools.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single group will be assessed before and after an educational session
primary purpose: Other
masking: None (Open Label)
measure: Knowledge about antibiotics
time frame: 4 months
description: Percentage of correct answers
measure: Awareness level
time frame: 4 months
description: Percentage
arm group label: MIU students and patents
arm group type: Other
description: Educational session
intervention type: Behavioral
intervention name: Experimental: Educational session
description: Each patient will receive educational session consisting of face-to-face interview, administration of posters, brochures and pamphlets.
arm group label: MIU students and patents
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mahassen M Farghaly, Professor
role: Study Director
affiliation: Vice president of community services and environmental awareness
facility: 
country: Egypt
citation: Cope AL, Wood F, Francis NA, Chestnutt IG. General dental practitioners' perceptions of antimicrobial use and resistance: a qualitative interview study. Br Dent J. 2014 Sep;217(5):E9. doi: 10.1038/sj.bdj.2014.761.
PMID: 25213543
citation: Mahajan, Dr. Manali. (2014). A Questionnaire based Survey on the Knowledge, Attitude and Practises about Antimicrobial Resistance and Usage among the Second year MBBS Students of a Teaching tertiary care Hospital in Central India. International Journal of Pharmacological Research.
citation: Tulip DE, Palmer NO. A retrospective investigation of the clinical management of patients attending an out of hours dental clinic in Merseyside under the new NHS dental contract. Br Dent J. 2008 Dec 20;205(12):659-64; discussion 648. doi: 10.1038/sj.bdj.2008.1044. Epub 2008 Dec 5.
PMID: 19057559
citation: Dailey YM, Martin MV. Are antibiotics being used appropriately for emergency dental treatment? Br Dent J. 2001 Oct 13;191(7):391-3. doi: 10.1038/sj.bdj.4801190.
PMID: 11697600
citation: Sweeney LC, Dave J, Chambers PA, Heritage J. Antibiotic resistance in general dental practice--a cause for concern? J Antimicrob Chemother. 2004 Apr;53(4):567-76. doi: 10.1093/jac/dkh137. Epub 2004 Feb 25.
PMID: 14985274
citation: Abu-Mostafa NA, Al-Mejlad NJ, Al-Yami AS, Al-Sakhin FZ, Al-Mudhi SA. A survey of awareness related to the use of antibiotics for dental issues among non-medical female university students in Riyadh, Saudi Arabia. J Infect Public Health. 2017 Nov-Dec;10(6):842-848. doi: 10.1016/j.jiph.2017.01.015. Epub 2017 Feb 21.
PMID: 28233723
citation: Metlay JP, Stafford RS, Singer DE. National trends in the use of antibiotics by primary care physicians for adult patients with cough. Arch Intern Med. 1998 Sep 14;158(16):1813-8. doi: 10.1001/archinte.158.16.1813.
PMID: 9738612
citation: McManus P, Hammond ML, Whicker SD, Primrose JG, Mant A, Fairall SR. Antibiotic use in the Australian community, 1990-1995. Med J Aust. 1997 Aug 4;167(3):124-7. doi: 10.5694/j.1326-5377.1997.tb138809.x.
PMID: 9269265
citation: Butler CC, Rollnick S, Pill R, Maggs-Rapport F, Stott N. Understanding the culture of prescribing: qualitative study of general practitioners' and patients' perceptions of antibiotics for sore throats. BMJ. 1998 Sep 5;317(7159):637-42. doi: 10.1136/bmj.317.7159.637.
PMID: 9727992
citation: Annual report of the chief medical officer, volume two, 2011. Infections and the rise of antimicrobial resistance.
citation: WHO Library Cataloguing-in-Publication Data. Antibiotic resistance: Multi-country public awareness survey .World Health Organization. 2015.
citation: Lewis MA. Why we must reduce dental prescription of antibiotics: European Union Antibiotic Awareness Day. Br Dent J. 2008 Nov 22;205(10):537-8. doi: 10.1038/sj.bdj.2008.984.
PMID: 19023306
citation: Wise R, Hart T, Cars O, Streulens M, Helmuth R, Huovinen P, Sprenger M. Antimicrobial resistance. Is a major threat to public health. BMJ. 1998 Sep 5;317(7159):609-10. doi: 10.1136/bmj.317.7159.609. No abstract available.
PMID: 9727981
citation: Aljadhey H, Assiri GA, Mahmoud MA, Al-Aqeel S, Murray M. Self-medication in Central Saudi Arabia. Community pharmacy consumers' perspectives. Saudi Med J. 2015 Mar;36(3):328-34. doi: 10.15537/smj.2015.3.10523.
PMID: 25737176
citation: Khan A K A, Banu G, K K R. Antibiotic Resistance and Usage-A Survey on the Knowledge, Attitude, Perceptions and Practices among the Medical Students of a Southern Indian Teaching Hospital. J Clin Diagn Res. 2013 Aug;7(8):1613-6. doi: 10.7860/JCDR/2013/6290.3230. Epub 2013 Jul 1.
PMID: 24086854
citation: Chen C, Chen YM, Hwang KL, Lin SJ, Yang CC, Tsay RW, Liu CE, Young TG. Behavior, attitudes and knowledge about antibiotic usage among residents of Changhua, Taiwan. J Microbiol Immunol Infect. 2005 Feb;38(1):53-9.
PMID: 15692628
citation: Srinivasan A, Song X, Richards A, Sinkowitz-Cochran R, Cardo D, Rand C. A survey of knowledge, attitudes, and beliefs of house staff physicians from various specialties concerning antimicrobial use and resistance. Arch Intern Med. 2004 Jul 12;164(13):1451-6. doi: 10.1001/archinte.164.13.1451.
PMID: 15249355
citation: Vanden Eng J, Marcus R, Hadler JL, Imhoff B, Vugia DJ, Cieslak PR, Zell E, Deneen V, McCombs KG, Zansky SM, Hawkins MA, Besser RE. Consumer attitudes and use of antibiotics. Emerg Infect Dis. 2003 Sep;9(9):1128-35. doi: 10.3201/eid0909.020591.
PMID: 14519251
citation: Azevedo MM, Pinheiro C, Yaphe J, Baltazar F. Portuguese students' knowledge of antibiotics: a cross-sectional study of secondary school and university students in Braga. BMC Public Health. 2009 Sep 23;9:359. doi: 10.1186/1471-2458-9-359.
PMID: 19775451
citation: Simpson SA, Wood F, Butler CC. General practitioners' perceptions of antimicrobial resistance: a qualitative study. J Antimicrob Chemother. 2007 Feb;59(2):292-6. doi: 10.1093/jac/dkl467. Epub 2006 Nov 16.
PMID: 17110392
citation: Wright EP, Jain P. Survey of antibiotic knowledge amongst final year medical students. J Antimicrob Chemother. 2004 Mar;53(3):550-1. doi: 10.1093/jac/dkh096. Epub 2004 Feb 4. No abstract available.
PMID: 14762052
citation: Andre M, Vernby A, Berg J, Lundborg CS. A survey of public knowledge and awareness related to antibiotic use and resistance in Sweden. J Antimicrob Chemother. 2010 Jun;65(6):1292-6. doi: 10.1093/jac/dkq104. Epub 2010 Apr 1.
PMID: 20360063
citation: Armitage, P., Berry, G., & Matthews, J. N. S. Statistical methods in medical research. Wiley Online Library,4rth edition, 2008
responsible party type: Sponsor
sharing ipd: No