Acute PharyngitisNCT01720927
Pakistan Epidemiological Survey in Acute Pharyngitis
An observational study of Acute Pharyngitis, run by Suresh Kumar at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Acute Pharyngitis
- How many people
- 5,140 participants
- Where
- 1 sitePakistan
- Study dates
- Nov 2012to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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)
Read the detailed description
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.
- Conditions
- Acute Pharyngitis
- Keywords
- Acute Pharyngitis, GABHS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute Pharyngitis | Subjects presenting with acute pharyngitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the prevalence of GABHS in patients with acute pharyngitis.
Measured: 12 months
Secondary outcomes (2)
To study the prevalence of GABHS in acute pharyngitis across different age groups.
Measured: 12 months
To study the correlation of centor score and RADT results.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PharyngitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suresh Kumar
- Sponsor type
- University, hospital or other
- Collaborators
- Isra University
- Responsible party
- Sponsor-investigator, Suresh Kumar, Hill Park General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720927
- Sponsor's protocol ID
- PK-12-02
- Status last verified
- Sep 2014
- First submitted
- 1 Nov 2012
- Last updated
- 15 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pakistan Epidemiological Survey in Acute Pharyngitis
- ClinicalTrials.gov ID
- NCT01720927
- Acronym / sponsor ID
- PK-12-02
- Conditions
- Acute Pharyngitis
- Keywords
- Acute Pharyngitis, GABHS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,140 participants (actual)
- Lead sponsor
- Suresh KumarUniversity, hospital or other
- Collaborators
- Isra University
- Study start
- Nov 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 2 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Pharyngitis | – | –Subjects presenting with acute pharyngitis |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the prevalence of GABHS in patients with acute pharyngitis.
Time frame: 12 months
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pharyngitis, run by Suresh Kumar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the prevalence of GABHS in patients with acute pharyngitis. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2014.