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Pakistan Epidemiological Survey in Acute Pharyngitis

This study has been completed.
Sponsor:
Collaborator:
ISRA University
Information provided by (Responsible Party):
Suresh Kumar, Hill Park General Hospital
ClinicalTrials.gov Identifier:
NCT01720927
First received: November 1, 2012
Last updated: September 12, 2014
Last verified: September 2014
  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 Hill Park General Hospital:

Primary Outcome Measures:
  • To evaluate the prevalence of GABHS in patients with acute pharyngitis. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To study the prevalence of GABHS in acute pharyngitis across different age groups. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To study the correlation of centor score and RADT results. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720927

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

No publications provided

Responsible Party: Suresh Kumar, Investigator, Hill Park General Hospital
ClinicalTrials.gov Identifier: NCT01720927     History of Changes
Other Study ID Numbers: PK-12-02
Study First Received: November 1, 2012
Last Updated: September 12, 2014
Health Authority: Pakistan: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 25, 2014