Safety outcomes and other predefined outcome measures
| No | Category | Specification | Time frame |
| 1 | Safety | Proportion of children with severe complications during antibiotic treatment, for example, need for intensive care, septic shock, organ failure, pyomyositis, endocarditis, deep venous thrombosis. | 28 days |
| 2 | Safety | Proportion of children with need for surgical intervention during antibiotic treatment. Diagnostic surgical intervention (diagnostic joint aspiration or diagnostic bone biopsy) excluded | 28 days |
| 3 | Safety | Proportion of children with treatment-related adverse events for example, complications of intravenous access (infection, need for replacement, extravasation) and drug side effects reported by medical staff or by parents (electronic questionnaire) | 3 months |
| 4 | Exploratory | Time to apyrexia from initiation of antibiotic treatment | 28 days |
| 5 | Exploratory | Level of mobility and pain assessed by daily grading of symptoms by medical staff and daily standardised pain scores from participants and/or parents. Score systems: Visual Analogue Scale or Face Legs Activity Cry Consolability scale, both with scores from 0 (no pain) to 10 (worst pain). | 14 days |
| 6 | Exploratory | Total duration of antibiotic therapy | 3 months |
| 7 | Exploratory | Proportion of children with sequelae, for example, abnormal mobility and growth abnormalities, assessed by clinical examination by a qualified paediatrician 12 months after the initiation of treatment, accepted range 11–14 months | 14 months |
| 8 | Exploratory | Proportion of children with radiological abnormalities assessed by a qualified radiologist 12 months after initiation of treatment, accepted range 11–14 months | 14 months |
| 9 | Exploratory | Secondary infection with antimicrobial-resistant organisms or Clostridioides difficile | 3 months |