Table 6 Secondary and additional outcomes. AE adverse event, CAP community-acquired pneumonia, DOOR desirability of outcome ranking, IMP investigational medicinal product, QoL quality of life, LFA lateral flow assay, RADAR response adjusted for duration of antibiotic risk, SAE serious adverse event, URT upper respiratory tract, VS vital signs

Secondary outcomes:

• Overall clinical outcome based on benefits (clinical response: normalization of all VS) and harms (solicited AEs: Table 7) using desirability of outcome ranking (DOOR) and response adjusted for duration of antibiotic risk (RADAR) approach (Table 8) [59].

• Time (days) to normalization of CAP-related symptoms (i.e., cough, shortness of breath, wheeze, chest pain, sore throat, nasal congestion or runny nose, headache, muscle aches or pains, nausea or vomiting, diarrhea, reduced general condition, decreased appetite, not sleeping well, reduced activity).

• QoL assessment of the patient’s family until day 28 using a standardized and validated QoL questionnaire [60].

• Time (days) to return to daily routine, defined as return to childcare/school/work of patients and their families.

• Development of M. pneumoniae-associated extrapulmonary manifestations [61, 62] within 28 days.

Additional outcomes:

• Length of hospital stay (days) in hospitalized patients after index hospitalization.

• Number of medical visits (apart from the study) until day 28.

• Proportion of patients (re-)treated with antibiotics for any reason until 28 days and total antibiotic exposure in days up to 28 days.

• AEs/SAEs of IMP.

• Microbiological indicators: proportion of patients who cleared M. pneumoniae in the URT within 28 days; proportion of patients in which M. pneumoniae became resistant to macrolides within 28 days; and proportion of patients with change in co-detecting pathogens in the URT at day 3 and 28.

• Inflammatory indicators: biomarker and cytokine profiling at day 3 and 28.

Other additional outcomes (independent of study intervention):

• Degree of usefulness of informational video about the study on a five-point Likert scale.