Table 3 Definitions of outcome measures
Term | Definition |
|---|---|
Clinical cure | Clinical judgement by physician 5–7 days after discontinuation of treatment. Patient completely recovered with no remaining/residual symptoms or clinical findings of pharyngotonsillitis or symptomatic relapse at TOC. |
Therapeutic failure | None or inadequate clinical effect during treatment period. |
Not evaluable for primary outcome | Follow-up after discontinuation of treatment is missing. |
Relapse | Symptomatic pharyngotonsillitis within one month after first diagnosis, according to clinical judgement by physician 1) antibiotic treatment necessary or 2) verified pharyngotonsillitis caused by streptococcus. Recurrent symptomatic pharyngotonsillitis presenting before and including the TOC visit, following at least 1 day without symptoms after initial treatment, will be judged as early relapse. |
Complication with suspected relation to the primary infection | For example peritonsillitis, acute otitis media or sinusitis during the study period, i.e. until the last follow-up visit. |
Bacteriological cure | Absence of GAS in culture. If culture is missing, a negative RADT. |
Asymptomatic carriage of GAS | Presence of GAS in culture from patient without throat symptoms. If culture is missing, a positive RADT. |
Symptomatic infection of GAS | Presence of GAS in culture from patient with throat symptoms. If culture is missing, a positive RADT. |