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Pakistan Epidemiological Survey in Acute Pharyngitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01720927
First Posted: November 2, 2012
Last Update Posted: September 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ISRA University
Information provided by (Responsible Party):
Suresh Kumar, Hill Park General Hospital
  Purpose

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)


Condition
Acute Pharyngitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pakistan Epidemiological Survey in Acute Pharyngitis

Resource links provided by NLM:


Further study details as provided by Suresh Kumar, Hill Park General Hospital:

Primary Outcome Measures:
  • To evaluate the prevalence of GABHS in patients with acute pharyngitis. [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • To study the prevalence of GABHS in acute pharyngitis across different age groups. [ Time Frame: 12 months ]
  • To study the correlation of centor score and RADT results. [ Time Frame: 12 months ]

Enrollment: 5140
Study Start Date: November 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acute Pharyngitis
Subjects presenting with acute pharyngitis

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include children and adults presenting with sore throat, temperature greater than 100.40 F, tonsillar exudates and cervical adenopathy will be included.
Criteria

Inclusion Criteria:

  • Male and female subjects with signs of acute pharyngitis (duration of symptoms < 14 days)
  • Subjects with sore throat
  • Fever with sudden onset (temperature > 100 0 F (380 C)
  • Exposure to Streptococcus within the preceding 2 weeks
  • Children 3 years of age and above
  • Subjects / guardians giving written authorization to participate in the study

Exclusion Criteria:

  • Recurrent or persistent cases of sore throat
  • Complicated pharyngitis (peritonsillar abscesses, Lemierre disease, Vincent's angina)
  • Severe comorbidity
  • Immunosuppression or history of acute rheumatic fever
  • Special circumstances, such as sore throat after travel in past 2 weeks, sore throat linked to sexual transmission or rare epidemics (e.g. diphtheria)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720927


Locations
Pakistan
ISRA University
Hyderabad, Sind, Pakistan
Sponsors and Collaborators
Suresh Kumar
ISRA University
  More Information

Responsible Party: Suresh Kumar, Investigator, Hill Park General Hospital
ClinicalTrials.gov Identifier: NCT01720927     History of Changes
Other Study ID Numbers: PK-12-02
First Submitted: November 1, 2012
First Posted: November 2, 2012
Last Update Posted: September 15, 2014
Last Verified: September 2014

Keywords provided by Suresh Kumar, Hill Park General Hospital:
Acute Pharyngitis, GABHS

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases