Mycoplasma pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae Key words Mycoplasma pneumoniae
Mycoplasma pneumoniae M. pneumoniae I M. pneumoniae
M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae γ
M. pneumoniae Table1. evaluated in analysis Treatment group Population Total ITT 33 3 63 PPS 6 8 14 ITT: Intention to treat, PPS: per protocol set M. pneumoniae M. pneumoniae M. pneumoniae Mycoplasma pneumoniae μ II
Table2.Subject summaries in the intention to treat population Parameters Classification Gender Male Female Age (yr) 1 25 611 12 Weight (kg) Inpatient or outpatient Severity of infection Underlying disease and / or complication Level of influence on the infectious disease Previous history Drug allergies Previous antimicrobial treatment 1 1,2 2,3 3,4 4 Inpatient Outpatient Mild Moderate Severe Slightly Moderate Serious Number of subjects (%) 33 15 (45.5) 18 (54.5) 2 (6.1) 19 (57.6) 9 (27.3) 3 (9.1) 1 (3.) 21 (63.6) 7 (21.2) 1 (3.) 3 (9.1) 2 (6.1) 31 (93.9) 25 (75.8) 8 (24.2) 2 (6.6) 13 (39.4) 1 (3.3) 3 (9.1) 31 (93.9) 2 (6.1) 32 (97.) 1 (3.) 33 (1) 3 15 (5.) 15 (5.) 8 (26.7) 1 (33.3) 11 (36.7) 1 (3.3) 7 (23.3) 14 (46.7) 7 (23.3) 2 (6.7) 4 (13.3) 26 (86.7) 22 (73.3) 7 (23.3) 1 (3.3) 14 (46.7) 16 (53.3) 16 (53.3) 27 (9.) 3 (1.) 3 (1) 3 (1)
Table3.Subject summaries in the per protocol set population Parameters Classification Number of subjects (%) Gender Male Female Age (yr) 1 25 611 12 Weight (kg) Inpatient or outpatient Severity of infection Underlying disease and / or complication Level of influence on the infectious disease Previous history Drug allergies Previous antimicrobial treatment 1 1,2 2,3 3,4 4 Inpatient Outpatient Mild Moderate Severe Slightly Moderate Serious 6 6 (1) 1 (16.7) 1 (16.7) 6 (1) 4 (66.7) 4 (66.7) 3 (5.) 1 (16.7) 6 (1) 5 (83.3) 1 (16.7) 6 (1) 8 5 (62.5) 3 (37.5) 2 (25.) 5 (62.5) 1 (12.5) 4 (5.) 3 (37.5) 1 (12.5) 1 (12.5) 7 (87.5) 4 (5.) 4 (5.) 4 (5.) 4 (5.) 4 (5.) 8 (1) 8 (1) 8 (1) Table4.Alleviation rate at end of treatment in the intention to treat population Group Alleviation Alleviation rate (%) 95% CI (%) Difference of alleviation rate (%) 95% CI of difference of alleviation rate (%) 33 31 93.9 79.8, 99.3 13.9 2.5, 3.4 3 24 8. 61.4, 92.3 Alleviation rate (%) (Number of subjects reached alleviation of fever / )1 Table5.Alleviation rate at end of treatment, excluding indeterminate in the intention to treat population Group Alleviation Alleviation rate (%) 95% CI (%) Difference of alleviation rate (%) 95% CI of difference of alleviation rate (%) 31 31 1 88.8, 1 4. 3.7, 11.7 25 24 96. 79.6, 99.9 Alleviation rate (%) (Number of subjects reached alleviation of fever / )1 M. pneumoniae M. pneumoniae
Table6.Clinical efficacy at end of treatment in the intention to treat population Group 33 3 Clinical efficacy Excellent Good Fair Poor Indeterminate 23 2 Efficacy (%) (Excellent and Good/ )1 9 7 3 1 Efficacy (%) 97. 9. 95% CI (%) 84.2, 99.9 73.5, 97.9 Table7.Clinical efficacy at end of treatment, excluding indeterminate in the intention to treat population Group 32 3 Clinical efficacy Excellent Good Fair Poor 23 2 Efficacy (%) (Excellent and Good/ )1 9 7 3 Efficacy (%) 1 9. 95% CI (%) 89.1, 1 73.5, 97.9 Table8.Bacteriological efficacy against M. pneumoniae Visit Group End of treatment Test of cure Evaluation of joint Eradication rate (%) (Eradication / )1 4 6 3 4 4 6 Bacteriological efficacy Eradication Persistence Indeterminate 4 4 3 3 4 5 2 1 1 Eradication rate (%) 1 66.7 1 75. 1 83.3 95% CI (%) 22.3, 95.7 35.9, 99.6 M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae MoraxellaBranhamella catarrhalis Haemophilus influenzae M.B.catarrhalis H. influenzae M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae
Table9.Frequency distribution of macrolide-resistant Mycoplasma pneumoniae in the intention to treat population Antibiotic susceptibility Number of clinical isolates (%) MIC of Mutations Number of clinical isolates (%) (n4) (n6) (g/ml) (n4) (n6) Sensitive 2 (5.) 4 (66.7) 16 2 (5.) 4 (66.7) Resistant 2 (5.) 16 2 (5.) 16 III M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae
System Organ Class and High Level Group Term Preferred Term Table1.Adverse events and Adverse drug reactions [n33] Adverse event Adverse drug reaction Adverse event (Incidence ) (Incidence ) (Incidence ) [n3] Adverse drug reaction (Incidence ) Total 22 (66.7) 34 5 (15.2) 5 2 (66.7) 31 3 (1.) 4 Gastrointestinal disorders 5 (15.2) 5 3 (9.1) 3 7 (23.3) 9 2 (6.7) 3 Vomiting 2 (6.1) 2 3 (1.) 3 1 (3.3) 1 Constipation 2 (6.1) 2 2 (6.1) 2 1 (3.3) 1 Diarrhea 1 (3.) 1 1 (3.) 1 4 (13.3) 4 2 (6.7) 2 Glossitis 1 (3.3) 1 General disorders and administration site conditions 1 (3.3) 1 Instillation site swelling 1 (3.3) 1 Immune system disorders 1 (3.) 1 Seasonal allergy 1 (3.) 1 Infections and infestations 9 (27.3) 1 8 (26.7) 9 Nasopharyngitis 5 (15.2) 5 Herpangina 2 (6.1) 2 Bronchitis 1 (3.) 1 2 (6.7) 2 Otitis media acute 1 (3.) 1 1 (3.3) 1 Varicella 1 (3.) 1 Gastroenteritis 3 (1.) 3 Beta haemolytic streptococcal infection 1 (3.3) 1 Acute sinusitis 1 (3.3) 1 Herpes virus infection 1 (3.3) 1 Injury, poisoning and procedural complications 3 (9.1) 4 Animal bite 1 (3.) 1 Arthropod sting 1 (3.) 1 Excoriation 1 (3.) 1 Contusion 1 (3.) 1 Musculoskeletal and connective tissue disorders 1 (3.) 1 1 (3.3) 1 Growing pains 1 (3.) 1 1 (3.3) 1 Nervous system disorders 1 (3.) 1 Presyncope 1 (3.) 1 Respiratory, thoracic and mediastinal disorders 6 (18.2) 6 7 (23.3) 7 Upper respiratory tract inflammation 5 (15.2) 5 2 (6.7) 2 Asthma 1 (3.) 1 2 (6.7) 2 Rhinorrhea 3 (1.) 3 (Continued) M. pneumoniae M. pneumoniae
System Organ Class and High Level Group Term Preferred Term Table1.(Continued) [n33] Adverse event Adverse drug reaction Adverse event (Incidence ) (Incidence ) (Incidence ) [n3] Adverse drug reaction (Incidence ) Skin and subcutaneous tissue disorders 5 (15.2) 5 1 (3.) 1 3 (1.) 3 Urticaria 2 (6.1) 2 Eczema 1 (3.) 1 1 (3.3) 1 Erythema polymorphe 1 (3.) 1 1 (3.) 1 Sweat rash 1 (3.) 1 Rash 2 (6.7) 2 Investigations 1 (3.) 1 1 (3.) 1 1 (3.3) 1 1 (3.3) 1 Haematology investigations (incl blood groups) 1 (3.) 1 1 (3.) 1 Eosinophil count increased 1 (3.) 1 1 (3.) 1 Renal and urinary tract investigations and urinalyses 1 (3.3) 1 1 (3.3) 1 Protein urine present 1 (3.3) 1 1 (3.3) 1 Incidence (%) ( with Adverse event or Adverse drug reaction / )1 M. pneumoniae S. pneumoniae H. influenzae H. influenzae H. influenzae M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae
Mycoplasma pneumoniae Mycoplasma pneumoniae Mycoplasma pneumoniae Mycoplasma pneumoniae
Mycoplasma pneumoniae Mycoplasma pneumoniae Mycoplasma pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae