PHASE III, OPEN-LABEL, RANDOMIZED, CONTROLLED, NON-INFERIORITY CLINICAL-TRIAL TO ASSESS THE EFFICACY AND SAFETY OF SHORT OUTPATIENT AMOXICILLIN REGIMENS IN CHILDREN WITH ACUTE STREPTOCOCCAL PHARYNGOTONSILLITIS (STOP

Conditions

ACUTE STREPTOCOCCAL PHARYNGOTONSILLITIS

Brief summary

Relapse: patients with reinfection by EbhGA within 15 days after completing the assigned antibiotic regimen.

Detailed description

Cure: number of patients with fever resolution 48 hours after starting the assigned antibiotic regimen., Suppurative complications. Suppurative complications are defined as: o Acute cellulitis. o Acute otitis media. o Acute sinusitis. o Acute mastoiditis. o Acute suppurative cervical adenitis. o Acute peritonsillar or retropharyngeal abscess. o Acute meningitis. o Acute cerebral abscess. o Acute thrombosis of the intracranial venous sinuses. o Acute streptococcal pneumonia. o Acute suppurative arthritis. o Acute osteomyelitis. o Acute liver abscess. o Acute endocarditis., Non-suppurative complications. Non-suppurative complications are defined as: o Acute rheumatic fever (Diagnostic criteria - Appendix B). o Acute post-streptococcal glomerulonephritis. o Acute post-streptococcal reactive arthritis. o Erythema nodosum. o Anaaphylactoid purpura. o PANDAS syndrome., New episodes of streptococcal FAA: presence of new episodes with TDR or positive throat culture for EbhGA during the 4-month follow-up period.

Related papers

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Interventions

DRUGAMOXICILLIN

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Relapse: patients with reinfection by EbhGA within 15 days after completing the assigned antibiotic regimen.	—

Secondary

Measure	Time frame
Cure: number of patients with fever resolution 48 hours after starting the assigned antibiotic regimen., Suppurative complications. Suppurative complications are defined as: o Acute cellulitis. o Acute otitis media. o Acute sinusitis. o Acute mastoiditis. o Acute suppurative cervical adenitis. o Acute peritonsillar or retropharyngeal abscess. o Acute meningitis. o Acute cerebral abscess. o Acute thrombosis of the intracranial venous sinuses. o Acute streptococcal pneumonia. o Acute suppurative arthritis. o Acute osteomyelitis. o Acute liver abscess. o Acute endocarditis., Non-suppurative complications. Non-suppurative complications are defined as: o Acute rheumatic fever (Diagnostic criteria - Appendix B). o Acute post-streptococcal glomerulonephritis. o Acute post-streptococcal reactive arthritis. o Erythema nodosum. o Anaaphylactoid purpura. o PANDAS syndrome., New episodes of streptococcal FAA: presence of new episodes with TDR or positive throat culture for EbhGA during the 4-month	—

Measure

Time frame

Cure: number of patients with fever resolution 48 hours after starting the assigned antibiotic regimen., Suppurative complications. Suppurative complications are defined as: o Acute cellulitis. o Acute otitis media. o Acute sinusitis. o Acute mastoiditis. o Acute suppurative cervical adenitis. o Acute peritonsillar or retropharyngeal abscess. o Acute meningitis. o Acute cerebral abscess. o Acute thrombosis of the intracranial venous sinuses. o Acute streptococcal pneumonia. o Acute suppurative arthritis. o Acute osteomyelitis. o Acute liver abscess. o Acute endocarditis., Non-suppurative complications. Non-suppurative complications are defined as: o Acute rheumatic fever (Diagnostic criteria - Appendix B). o Acute post-streptococcal glomerulonephritis. o Acute post-streptococcal reactive arthritis. o Erythema nodosum. o Anaaphylactoid purpura. o PANDAS syndrome., New episodes of streptococcal FAA: presence of new episodes with TDR or positive throat culture for EbhGA during the 4-month

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Outcome results

None listed

PHASE III, OPEN-LABEL, RANDOMIZED, CONTROLLED, NON-INFERIORITY CLINICAL-TRIAL TO ASSESS THE EFFICACY AND SAFETY OF SHORT OUTPATIENT AMOXICILLIN REGIMENS IN CHILDREN WITH ACUTE STREPTOCOCCAL PHARYNGOTONSILLITIS (STOP – TRIAL)