<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/NCT01720927</url>
  </required_header>
  <id_info>
    <org_study_id>PK-12-02</org_study_id>
    <nct_id>NCT01720927</nct_id>
  </id_info>
  <brief_title>Pakistan Epidemiological Survey in Acute Pharyngitis</brief_title>
  <official_title>Pakistan Epidemiological Survey in Acute Pharyngitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Suresh Kumar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Isra University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hill Park General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      GABHS are common etiological agents for acute pharyngitis. However, local data is limited and&#xD;
      large scale surveillance studies have not been done. This study aims to evaluate the disease&#xD;
      burden in the community due to GABHS.&#xD;
&#xD;
      In this study, patients presenting with signs of acute pharyngitis will be evaluated.&#xD;
      Patients with fulfilling the inclusion criteria will be tested for Rapid Antigen Detection&#xD;
      test (RADT)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pharyngitis is a common reason for patients' visit to doctors. Group A beta- hemolytic&#xD;
      streptococci (GABHS) account for 15-30 percent of cases of acute pharyngitis in children and&#xD;
      5 to 20 percent in adults1.&#xD;
&#xD;
      Because the signs and symptoms of GABHS pharyngitis overlap extensively with other infectious&#xD;
      causes, making a diagnosis based solely on clinical findings is difficult. In patients with&#xD;
      acute febrile respiratory illness, physicians accurately differentiate bacterial from viral&#xD;
      infections using only the history and physical findings about one half of the time.2 No&#xD;
      single element of the patient's history or physical examination reliably confirms or excludes&#xD;
      GABHS pharyngitis.3 Sore throat, fever with sudden onset (temperature greater than 100.4° F&#xD;
      [38° C]), and exposure to Streptococcus within the preceding two weeks suggest GABHS&#xD;
      infection. Cervical node lymphadenopathy and pharyngeal or tonsillar inflammation or exudates&#xD;
      are common signs. Palatal petechiae and scarlatiniform rash are highly specific but uncommon;&#xD;
      a swollen uvula is sometimes noted. Cough, coryza, conjunctivitis, and diarrhea are more&#xD;
      common with viral pharyngitis.&#xD;
&#xD;
      The original Centor score uses four signs and symptoms to estimate the probability of acute&#xD;
      streptococcal pharyngitis in adults with a sore throat.4 The score was later modified by&#xD;
      adding age and validated in 600 adults and children.5,6 The cumulative score determines the&#xD;
      likelihood of streptococcal pharyngitis.&#xD;
&#xD;
      Rapid Antigen Detection Tests (RADTs) have been developed for the identification of GABHS&#xD;
      directly from throat swabs. Although these rapid tests are more expensive than blood agar&#xD;
      culture, they provide results faster. Rapid identification and treatment of patients with&#xD;
      streptococcal pharyngitis can reduce the risk of the spread of group A b-hemolytic&#xD;
      streptococci, allowing the patient to return to school or work sooner, and can reduce the&#xD;
      acute morbidity associated with the illness. The use of RADTs for certain populations (e.g.,&#xD;
      patients in emergency departments) has been shown to significantly increase the number of&#xD;
      patients who are appropriately treated for streptococcal pharyngitis, compared with use of&#xD;
      traditional throat cultures.7&#xD;
&#xD;
      The great majority of the RADTs that are currently available have an excellent specificity of&#xD;
      95%, compared with blood agar plate culture. This means that false-positive test results are&#xD;
      unusual, and, therefore, therapeutic decisions can be made with confidence on the basis of a&#xD;
      positive test result. Unfortunately, the sensitivity of most of these tests is 80%-90%, or&#xD;
      even lower, compared with blood agar plate culture. It has been suggested that most of the&#xD;
      false-negative RADT results occur for patients who are merely Streptococcus carriers and are&#xD;
      not truly infected. However, early studies of first-generation RADTs demonstrated that a&#xD;
      large proportion of patients with false-negative RADT results were truly infected with group&#xD;
      A b-hemolytic streptococci and were not merely carriers.8&#xD;
&#xD;
      Acute pharyngitis is commonly encountered in clinics and hospitals across Pakistan. It is&#xD;
      common not only in children but also among adults. Limited data are available on the&#xD;
      prevalence of this condition and existing data are from small single center based studies.&#xD;
&#xD;
      The available data from Pakistan suggest that the most common bacterial organism is GABHS,&#xD;
      however, majority of throat swabs did not yield any isolate.9 The signs and symptoms of GABHS&#xD;
      pharyngitis overlap extensively with other infectious causes, thus to make an etiologic&#xD;
      diagnosis based solely on clinical findings is difficult. Improving diagnosis of bacterial&#xD;
      causes of pharyngitis will lead to more rational use of antibiotics among clinicians, and&#xD;
      potentially have a positive impact on the development of bacterial resistance in community&#xD;
      acquired infections.&#xD;
&#xD;
      The modified Centor score is a valid tool to estimate the probability of acute streptococcal&#xD;
      pharyngitis in patients with a sore throat. (reference) Patients with a score of zero or 1&#xD;
      are at very low risk for streptococcal pharyngitis and do not require testing (i.e., throat&#xD;
      culture or rapid antigen detection testing [RADT]) or antibiotic therapy. Patients with a&#xD;
      score of 2 or 3 should be tested using RADT or throat culture; positive results warrant&#xD;
      antibiotic therapy. Patients with a score of 4 or higher are at high risk of streptococcal&#xD;
      pharyngitis, and empiric treatment may be considered. (reference)&#xD;
&#xD;
      RADT allows for earlier treatment, symptom improvement, and reduced disease spread.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</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>To evaluate the prevalence of GABHS in patients with acute pharyngitis.</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To study the prevalence of GABHS in acute pharyngitis across different age groups.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To study the correlation of centor score and RADT results.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">5140</enrollment>
  <condition>Acute Pharyngitis</condition>
  <arm_group>
    <arm_group_label>Acute Pharyngitis</arm_group_label>
    <description>Subjects presenting with acute pharyngitis</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include children and adults presenting with sore throat,&#xD;
        temperature greater than 100.40 F, tonsillar exudates and cervical adenopathy will be&#xD;
        included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects with signs of acute pharyngitis (duration of symptoms &lt; 14&#xD;
             days)&#xD;
&#xD;
          -  Subjects with sore throat&#xD;
&#xD;
          -  Fever with sudden onset (temperature &gt; 100 0 F (380 C)&#xD;
&#xD;
          -  Exposure to Streptococcus within the preceding 2 weeks&#xD;
&#xD;
          -  Children 3 years of age and above&#xD;
&#xD;
          -  Subjects / guardians giving written authorization to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recurrent or persistent cases of sore throat&#xD;
&#xD;
          -  Complicated pharyngitis (peritonsillar abscesses, Lemierre disease, Vincent's angina)&#xD;
&#xD;
          -  Severe comorbidity&#xD;
&#xD;
          -  Immunosuppression or history of acute rheumatic fever&#xD;
&#xD;
          -  Special circumstances, such as sore throat after travel in past 2 weeks, sore throat&#xD;
             linked to sexual transmission or rare epidemics (e.g. diphtheria)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ISRA University</name>
      <address>
        <city>Hyderabad</city>
        <state>Sind</state>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>September 12, 2014</last_update_submitted>
  <last_update_submitted_qc>September 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hill Park General Hospital</investigator_affiliation>
    <investigator_full_name>Suresh Kumar</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <keyword>Acute Pharyngitis, GABHS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharyngitis</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/NCT01720927
org study id: PK-12-02
nct id: NCT01720927
lead sponsor: 
collaborator: 
has dmc: No
GABHS are common etiological agents for acute pharyngitis. However, local data is limited and
      large scale surveillance studies have not been done. This study aims to evaluate the disease
      burden in the community due to GABHS.

      In this study, patients presenting with signs of acute pharyngitis will be evaluated.
      Patients with fulfilling the inclusion criteria will be tested for Rapid Antigen Detection
      test (RADT)
Pharyngitis is a common reason for patients' visit to doctors. Group A beta- hemolytic
      streptococci (GABHS) account for 15-30 percent of cases of acute pharyngitis in children and
      5 to 20 percent in adults1.

      Because the signs and symptoms of GABHS pharyngitis overlap extensively with other infectious
      causes, making a diagnosis based solely on clinical findings is difficult. In patients with
      acute febrile respiratory illness, physicians accurately differentiate bacterial from viral
      infections using only the history and physical findings about one half of the time.2 No
      single element of the patient's history or physical examination reliably confirms or excludes
      GABHS pharyngitis.3 Sore throat, fever with sudden onset (temperature greater than 100.4° F
      [38° C]), and exposure to Streptococcus within the preceding two weeks suggest GABHS
      infection. Cervical node lymphadenopathy and pharyngeal or tonsillar inflammation or exudates
      are common signs. Palatal petechiae and scarlatiniform rash are highly specific but uncommon;
      a swollen uvula is sometimes noted. Cough, coryza, conjunctivitis, and diarrhea are more
      common with viral pharyngitis.

      The original Centor score uses four signs and symptoms to estimate the probability of acute
      streptococcal pharyngitis in adults with a sore throat.4 The score was later modified by
      adding age and validated in 600 adults and children.5,6 The cumulative score determines the
      likelihood of streptococcal pharyngitis.

      Rapid Antigen Detection Tests (RADTs) have been developed for the identification of GABHS
      directly from throat swabs. Although these rapid tests are more expensive than blood agar
      culture, they provide results faster. Rapid identification and treatment of patients with
      streptococcal pharyngitis can reduce the risk of the spread of group A b-hemolytic
      streptococci, allowing the patient to return to school or work sooner, and can reduce the
      acute morbidity associated with the illness. The use of RADTs for certain populations (e.g.,
      patients in emergency departments) has been shown to significantly increase the number of
      patients who are appropriately treated for streptococcal pharyngitis, compared with use of
      traditional throat cultures.7

      The great majority of the RADTs that are currently available have an excellent specificity of
      95%, compared with blood agar plate culture. This means that false-positive test results are
      unusual, and, therefore, therapeutic decisions can be made with confidence on the basis of a
      positive test result. Unfortunately, the sensitivity of most of these tests is 80%-90%, or
      even lower, compared with blood agar plate culture. It has been suggested that most of the
      false-negative RADT results occur for patients who are merely Streptococcus carriers and are
      not truly infected. However, early studies of first-generation RADTs demonstrated that a
      large proportion of patients with false-negative RADT results were truly infected with group
      A b-hemolytic streptococci and were not merely carriers.8

      Acute pharyngitis is commonly encountered in clinics and hospitals across Pakistan. It is
      common not only in children but also among adults. Limited data are available on the
      prevalence of this condition and existing data are from small single center based studies.

      The available data from Pakistan suggest that the most common bacterial organism is GABHS,
      however, majority of throat swabs did not yield any isolate.9 The signs and symptoms of GABHS
      pharyngitis overlap extensively with other infectious causes, thus to make an etiologic
      diagnosis based solely on clinical findings is difficult. Improving diagnosis of bacterial
      causes of pharyngitis will lead to more rational use of antibiotics among clinicians, and
      potentially have a positive impact on the development of bacterial resistance in community
      acquired infections.

      The modified Centor score is a valid tool to estimate the probability of acute streptococcal
      pharyngitis in patients with a sore throat. (reference) Patients with a score of zero or 1
      are at very low risk for streptococcal pharyngitis and do not require testing (i.e., throat
      culture or rapid antigen detection testing [RADT]) or antibiotic therapy. Patients with a
      score of 2 or 3 should be tested using RADT or throat culture; positive results warrant
      antibiotic therapy. Patients with a score of 4 or higher are at high risk of streptococcal
      pharyngitis, and empiric treatment may be considered. (reference)

      RADT allows for earlier treatment, symptom improvement, and reduced disease spread.
observational model: Case-Only
time perspective: Prospective
measure: To evaluate the prevalence of GABHS in patients with acute pharyngitis.
time frame: 12 months
measure: To study the prevalence of GABHS in acute pharyngitis across different age groups.
time frame: 12 months
measure: To study the correlation of centor score and RADT results.
time frame: 12 months
arm group label: Acute Pharyngitis
description: Subjects presenting with acute pharyngitis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Pakistan
responsible party type: Sponsor-Investigator
investigator affiliation: Hill Park General Hospital
investigator full name: Suresh Kumar
investigator title: Investigator
mesh term: Pharyngitis