Table 1.

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