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临床试验/NCT01720927
NCT01720927已完成不适用

Pakistan Epidemiological Survey in Acute Pharyngitis

Suresh Kumar1 个研究点 分布在 1 个国家目标入组 5,140 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5,140
试验地点
1
主要终点
To evaluate the prevalence of GABHS in patients with acute pharyngitis.

研究概览

简要总结

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)

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
3 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

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

时间窗: 12 months

次要结局

  • To study the correlation of centor score and RADT results.(12 months)
  • To study the prevalence of GABHS in acute pharyngitis across different age groups.(12 months)

研究者

发起方
Suresh Kumar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Suresh Kumar

Investigator

Hill Park General Hospital

研究点 (1)

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