Authors
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Universidade de São Paulo -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2019
INTERVENTION: All patients with clinical suspicion of pharyngotonsillitis will be examined and investigated for fever, tonsillar hypertrophy, tonsillar exudates, anterior cervical adenomegaly, mucosal lesions (petechiae, vesicles, exulcerations), cough, nasal obstruction, tearing and diarrhea. Patients will then be assessed for inclusion and exclusion criteria. Once it is admitted to the study, oropharynx smears will be collected for rapid testing to EBHGA, Gram staining and general culture on blood, chocolate and Mac Conkey; polymerase chain reaction for Fusobacterium necrophorum (Bank F et al., 2010) and panel detection of respiratory viruses by polymerase chain reaction (influenza A and B viruses, adenovirus, Rhinovirus, coronavirus and EBV). According to the positivity in the rapid test for EBGA detection, the patient will be divided into groups A (TR +) and Group B (TR‐). As patients are admitted to groups A and B, they will be randomly divided again to receive photodynamic therapy (PDT) or not. In this way four groups of participants will be constituted: Group A1 = Antibiotic therapy + photodynamic therapy; Group A2 = Antibiotic therapy + placebo of photodynamic therapy; Group B1 = Photodynamic therapy; Group B2 = Placebo of photodynamic therapy. A total of 1.2 x (22 + 82) = 125 patients should be included. Thus, the distribution of a total of 126 patients will be: Group A1: 13 patients Group A2: 13 patients Group B1: 50 patients Group B2: 50 patients Patients selected for photodynamic therapy will suck two bullets with photosensitizer (FS), the natural curcumin from PDT Pharma (http://www.pdtpharma.com.br/). The concentration of curcumin to be used will be 0.75 mg / mL or 22.5 mg / bullet. After the patient sucks the curcumin bullet, the oral cavity will be illuminated with blue light emitting system (LED), with a wavelength of 450 nm. The lighting system (Patent: BR10201601347) ensures that the illumination of the oropharynx is homogeneous w Bacterial Adhesion Device Drug Pharyngitis Photochemotherapy Tonsillitis CONDITION: Acute tonsillitis Bacterial Infections and Mycoses C07.550.781 C07.550.781.750 Pharyngitis pharyngotonsillitis; bacterial infections and mycoses; pharyngitis; pathological conditions, signs and symptoms; acute tonsillitis ; Bacterial Infections and Mycoses ; Pharyngitis ; Tonsillitis ; Acute tonsillitis Tonsillitis PRIMARY OUTCOME: First expected outcome: negativation of counting colonies of EBHGA in culture of oropharyngeal swabs, verified after five minutes and after two days of intervention Second expected outcome: fever resolution, verified by the rate of fever resolution in two days of treatment, and by the number of days until the fever resolution. Third expected outcome: pain relief, as assessed by pain relief rate at two days of treatment, and by number of days until resolution of sore throat. SECONDARY OUTCOME: Another secondary outcome observed is whether there is a reduction in the number of pharyngotonsillitis recurrences in two months The secondary endpoints aim in particular to verify if there is a decrease in the rate of complications, measured by the rate of occurrence of Lemierre syndrome (septic thrombophlebitis), by the rate of evolution with peritonsillar abscess in two weeks; by the post‐streptococcal GNDA development rate at one month, and by the frequency of development rheumatic fever at two months. INCLUSION CRITERIA: INCLUSION CRITERIA: Age between 18a and 45a; Signature of the Informed Consent Form; Presence of fever> 38ºC, oropharyngeal hyperemia, hypertrophy or presence of exudate in palatine tonsils.
Epistemonikos ID: 18c70160b000d5e268f69813acce941341dd7607
First added on: Aug 24, 2024