Table 1

Safety outcomes and other predefined outcome measures

NoCategorySpecificationTime frame
1SafetyProportion 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
2SafetyProportion of children with need for surgical intervention during antibiotic treatment. Diagnostic surgical intervention (diagnostic joint aspiration or diagnostic bone biopsy) excluded28 days
3SafetyProportion 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
4ExploratoryTime to apyrexia from initiation of antibiotic treatment28 days
5ExploratoryLevel 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
6ExploratoryTotal duration of antibiotic therapy3 months
7ExploratoryProportion 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 months14 months
8ExploratoryProportion of children with radiological abnormalities assessed by a qualified radiologist 12 months after initiation of treatment, accepted range 11–14 months14 months
9ExploratorySecondary infection with antimicrobial-resistant organisms or Clostridioides difficile3 months