Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis
Palabras clave
Abstracto
Descripción
Strep pharyngitis, or strep throat, is a common infection afflicting children, aged 2 and above. Testing for strep pharyngitis consists of a rapid test and/or a throat culture. However, it has been observed that rapid testing may not be accurate in children with a recent history of strep pharyngitis. Therefore, this study aims to determine the accuracy of rapid strep testing in children who are presenting with symptoms of strep throat, who also have a recent history of and treatment for strep pharyngitis. By demonstrating an inaccuracy in rapid strep testing in patients with a recent history of strep pharyngitis, unnecessary testing and antibiotic use may be decreased, thereby reducing costs, overuse of antibiotics, and antibiotic resistance.
The participants in the study will include 600 children, aged 2 to 20 years old, selected from a private practice in Northern Virginia who present to the practice with signs or symptoms suggestive of acute pharyngitis. Subjects are children who are presenting with signs and symptoms suggestive of acute pharyngitis by the Centor criteria, including sore throat, fever, abdominal pain and cervical lymphadenitis. Any child with above presenting symptoms who is to undergo Streptococcus rapid antigen testing will be recruited to participate in the study.
A letter of consent will be provided to the parents and guardians of the involved child, stating that the study will be voluntary and confidential, and that all results will be kept in a safe environment.
Investigators will be testing the difference between two proportions, the false positive rate in previously treated compared to those not treated.
fechas
| Verificado por última vez: | 05/31/2018 |
| Primero enviado: | 02/08/2017 |
| Inscripción estimada enviada: | 02/13/2017 |
| Publicado por primera vez: | 02/15/2017 |
| Última actualización enviada: | 06/04/2018 |
| Última actualización publicada: | 06/06/2018 |
| Fecha de inicio real del estudio: | 05/08/2013 |
| Fecha estimada de finalización primaria: | 01/15/2018 |
| Fecha estimada de finalización del estudio: | 01/15/2018 |
Condición o enfermedad
Intervención / tratamiento
Diagnostic Test: Rapid strep antigen detection test
Diagnostic Test: throat culture
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Group 1 / Study Group Subjects presenting with signs or symptoms of acute pharyngitis, with a history of culture-proven GAS infection and subsequent 10-day antibiotic treatment within the preceding 28 days. Subjects will have a rapid strep antigen detection test and a throat culture to determine presence of strep. | |
| Group 2 / Control Group Subjects presenting with signs or symptoms of acute pharyngitis, without a recent history of GAS infection. Subjects will have a rapid strep antigen detection test and a throat culture to determine presence of strep. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 2 Years A 2 Years |
| Sexos elegibles para estudiar | All |
| Método de muestreo | Non-Probability Sample |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - 2-20 years old - Current signs and symptoms suggestive of acute pharyngitis, including sore throat, fever, abdominal pain and cervical lymphadenitis. Exclusion Criteria: - Potential subjects who have been treated with less than 10 days of antibiotic therapy - Patients who report non-compliance with previous antibiotic therapy - Patients who have already been included in the study and children with evidence of GAS carrier status |
Salir
Medidas de resultado primarias
1. Rate of false positives and false negatives in rapid antigen testing compared to throat culture [48-72 hours]
