NCT01720927

Brief Summary

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,140

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

September 15, 2014

Status Verified

September 1, 2014

Enrollment Period

1 year

First QC Date

November 1, 2012

Last Update Submit

September 12, 2014

Conditions

Keywords

Acute Pharyngitis, GABHS

Outcome Measures

Primary Outcomes (1)

  • To evaluate the prevalence of GABHS in patients with acute pharyngitis.

    12 months

Secondary Outcomes (2)

  • To study the prevalence of GABHS in acute pharyngitis across different age groups.

    12 months

  • To study the correlation of centor score and RADT results.

    12 months

Study Arms (1)

Acute Pharyngitis

Subjects presenting with acute pharyngitis

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISRA University

Hyderābād, Sindh, Pakistan

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

November 1, 2012

First Posted

November 2, 2012

Study Start

November 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

September 15, 2014

Record last verified: 2014-09

Locations