THE JAPANESE JOURNAL OF ANTIBIOTICS 68 3 June 2015 Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis % 2 S. pneumon
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1 June 2015 THE JAPANESE JOURNAL OF ANTIBIOTICS : : 14 CVA/AMPC 1 : CVA/AMPC 1 : % Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis β- BLNAR β- BLPAR β- / BLPACR 80% CVA/AMPC 1 : 14 MIC BLNAR BLPAR BLPACR 1 4 μg/ml 19% 5/27 CVA/AMPC 1 : 14 M. catarrhalis β- I. 1
2 THE JAPANESE JOURNAL OF ANTIBIOTICS 68 3 June 2015 Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis % 2 S. pneumoniae M. catarrhalis, H. influenzae M. catarrhalis 3 S. pneumoniae Penicillin intermediately resistant S. pneumoniae: PISP S. pneumoniae Penicillin resistant S. pneumoniae: PRSP M. catarrhalis BRO β - β- H. influenzae CVA/AMPC 1 : 14 β- CVA AMPC 1 : 14 CVA AMPC AMPC β- Staphylococcus H. influenzae, M. catarrhalis, Klebsiella Proteus β- PRSP CVA AMPC 4 β- CVA/AMPC 1 : 14 S. pneumoniae, M. catarrhalis, H. influenzae CVA/AMPC CVA/AMPC 1, CVA/ AMPC 1 : 14 CVA/AMPC 1 : 14 II. 3 good clinical practice GCP ClinicalTrials. gov ID: NCT kg 40 kg
3 June 2015 THE JAPANESE JOURNAL OF ANTIBIOTICS CVA/AMPC 1 : Day 1 Day 4 Day 8 Day 15 4 CVA 6.4 mg / kg/ AMPC 90 mg /kg/ CVA/AMPC 1 : kg 11 kg 1.01 g 11 kg 17 kg 2.02 g 17 kg 24 kg 3.03 g 24 kg 31 kg 4.04 g 31 kg 37 kg 5.05 g 37 kg 40 kg 6.06 g CVA/AMPC , 2, 1, FEW, NEG 4 S. pneumoniae, H. influenzae, M. catarrhalis, Staphylococcus aureus, Streptococcus pyogenes CVA/AMPC 1 : 14, AMPC, cefditoren CDTR, cefcapene CFPN, clarithromycin CAM 5 S. pneumoniae, H. influenzae, S. aureus benzylpenicillin PCG, ampicillin ABPC, oxacillin MPIPC
4 THE JAPANESE JOURNAL OF ANTIBIOTICS 68 3 June 2015 Clinical and Laboratory Standards Institute CLSI 7 a. S. pneumoniae PCG Minimum Inhibitory Concentration MIC MIC 2 μg/ml Penicillin susceptible S. pneumoniae: PSSP MIC 4 μg/ml PISP MIC 8 μg/ml PRSP b. H. influenzae ABPC MIC β- MIC 2 μg/ml β- β-lactamase non-producing ABPC susceptible strain: BLNAS MIC 4 μg/ml β- β-lactamase nonproducing ABPC resistant strain: BLNAR β - β-lactamase producing ABPC resistant strain: BLPAR c. S. aureus MPIPC MIC MIC 2 μg/ml methicillin susceptible S. aureus: MSSA MIC 4 μg/ml methicillin resistant S. aureus: MRSA 4. CVA/AMPC 1 : CVA/ AMPC 1 : Full Analysis Set FAS FAS % Per Protocol Set PPS PPS Bacteriology PPS 1 Safety Population SP MIC ICH MedDRA Version 16.1 SOC PT % SP
5 June 2015 THE JAPANESE JOURNAL OF ANTIBIOTICS III. β-lactamase producing AMPC/CVA resistant strain: BLPACR M. catarrhalis β- S. aureus MSSA 1 1. CVA/ AMPC 1 : FAS SP PPS Bacteriology PPS 2 24 PPS kg kg 58% 14/ % 3/ % 7/ S. pneumoniae 9 23% H. influenzae 14 36% M. catarrhalis 6 15% S. aureus 5 13% S. pneumoniae % PSSP 1 11% PISP PRSP H. influenzae % BLNAS 3 21% BLNAR 1 7% BLPAR BLPAR 1 CVA/AMPC MIC 8 μg/ml β- / % 25/ % 23/ PSSP, BLNAS, M. catarrhalis PPS
6 THE JAPANESE JOURNAL OF ANTIBIOTICS 68 3 June M. catarrhalis 1 PSSP, BLPAR, M. catarrhalis 3 BLPAR 2 92% 24/26 77% 20/26 96% 25/ % 20/ % 54% 58% 81% 92% 69% 78% 92% 3 S. pneumoniae 88.9% 8/9 M. catarrhalis 6/6 AMPC β- 100% H. influenzae BLNAS 80% 8/10 BLNAR 3 BLPAR 1 4 CVA/AMPC BLPAR 1 CVA/AMPC MIC 8 μg/ml H. influenzae BLPACR 8 4 MIC CVA/AMPC 1 : 14 MIC PSSP μg/ml 3. PPS
7 June 2015 THE JAPANESE JOURNAL OF ANTIBIOTICS Bacteriology PPS PISP 1 2 μg/ml BLNAS μg/ml β- M. catarrhalis μg/ml MSSA μg/ml BLNAR 3 MIC 2 8 μg/ml BLPACR 1 MIC 8 μg/ml AMPC β- M. catarrhalis 6 MIC μg/ml % 11/27 19% 5/ PPS 26.9% 7/ % 10/ % 17/ % IV. 3 15
8 THE JAPANESE JOURNAL OF ANTIBIOTICS 68 3 June MIC Bacteriology PPS
9 June 2015 THE JAPANESE JOURNAL OF ANTIBIOTICS CVA/AMPC 1 : S. pneumoniae 33.3% H. influenzae 33.3% M. catarrhalis 20.8% 6 19 S. pneumoniae 7.7% H. influenzae 15.4% M. catarrhalis 7.7% 3 2 S. pneumoniae 23% H. influenzae 36% M. catarrhalis 15% 88.5% 96.2% CVA/AMPC 1 : 14 94% 10 CVA/AMPC 1 : 14 2 CVA/AMPC 1 : 14
10 THE JAPANESE JOURNAL OF ANTIBIOTICS 68 3 June 2015 CVA/AMPC 1 : Time above MIC T MIC % 40% 11 T MIC % CVA/AMPC 1 : AMPC MIC 4 μg/ml T MIC 46% CVA/ AMPC 1 : 14 MIC 4 μg/ml 10 CVA/ AMPC 1 : 14 80% MIC range S. pneumoniae PSSP 87.5%: μg/ml PISP 100%: 2 μg/ml CVA/AMPC 1 : 14 H. influenzae BLNAS 80.0%: μg/ml β- M. catarrhalis 100%: μg/ml S. aureus MSSA 100%: μg/ml MIC 4 μg/ml AMPC β- M. catarrhalis AMPC MIC μg/ml CVA/AMPC 1 : 14 MIC AMPC β- β- S. pneumoniae M. catarrhalis M. catarrhalis β- 12 M. catarrhalis S. pneumoniae M. catarrhalis β- CVA/AMPC 1 : β- M. catarrhalis CVA/ AMPC 1 : % MIC M. catarrhalis CVA/AMPC 1 : 14 β- MIC CVA/ AMPC 1 : 14 MIC 14 MIC 8 μg/ml 2 BLNAR 1 BLPAR BLPACR 1 HOSHINO H. influenzae BLPACR %, % 8 CVA/AMPC 1 : 14 BLPACR 9 CVA/AMPC 1 : 14 CVA/AMPC 1 : 14 β-
11 June 2015 THE JAPANESE JOURNAL OF ANTIBIOTICS : , : 15 26, clavulanic acid/amoxicillin Jpn. J. Antibiotics 52: , BROOK, I.; P. A. FOOTE & J. N. HAUSFELD: Eradication of pathogens from the nasopharynx after therapy of acute maxillary sinusitis with low- or high-dose amoxicillin/clavulanic acid. Int. J. Antimicrob. Agents 26: , CHOW, A. W.; M. S. BENNINGER, I. BROOK, et al.: ISDA clinical practice guideline for acute bacterial rhinosinusitis in children and adults. Clin. Infect. Dis. 54: e72 e112, : , Clinical and Laboratory Standards Institute. Performance standards for antimicrobial susceptibility testing; twenty-third informational supplement HOSHINO, T.; Y. SATO, Y. TOYONAGA, et al.: Nationwide survey of the development of drug resistance in the pediatric field in 2007 and 2010: drug sensitivity of Haemophilus influenzae in Japan second report J. Infect. Chemother. 19: , : , CRAIG, W. A. & D. ANDES: Pharmacokinetics and pharmacodynamics of antibiotics in otitis media. Pediatr. Infect. Dis. J. 15: , : , MB ENT 142: 9 17, Clavulanic acid/amoxicillin 1 : 14 Jpn. J. Antibiotics 66: , 2013
12 THE JAPANESE JOURNAL OF ANTIBIOTICS 68 3 June 2015 Efficacy and safety of clavulanic acid/amoxicillin 1 : 14 dry syrup in the treatment of children with acute bacterial rhinosinusitis RINYA SUGITA 1, SHUICHI YAMAMOTO 2, HIDEKATSU MOTOYAMA 2 and MASAO YARITA 3 1 Sugita ENT Clinic 2 Medicines Development, Japan Development & Medical Affairs Division, GlaxoSmithKline K.K. 3 Clinical Platforms & Sciences, Japan Development & Medical Affairs Division, GlaxoSmithKline K.K. To demonstrate clinical value of clavulanic acid/amoxicillin CVA/AMPC 1 : 14 combination dry syrup for acute bacterial rhinosinusitis ABRS, the efficacy and safety were evaluated in a multicenter, open-label, uncontrolled study in 27 children with ABRS. The proportion of subjects who were cured at the test of cure as the primary endpoint was 88.5%. In subjects with a major pathogenic bacteria at baseline i.e., Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis bacterial eradication was achieved in 80% of the subjects with the exception of β-lactamase non-producing ampicillin resistant H. influenzae: BLNAR and β-lactamase producing ampicillin resistant H. influenzae: BLPAR β-lactamase producing amoxicillin/clavulanic acid resistant H. influenzae: BLPACR. The MIC of CVA/AMPC 1 : 14 was not higher than 4 μg/ml for all pathogens except one strain each of BLNAR and BLPAR BLPACR. Drug-related adverse events were reported in 19% of patients 5/27 patients. All of the reported drug-related adverse events were classified as gastrointestinal disorders that have been commonly reported with antibacterial drugs. These results indicate that CVA/AMPC 1 : 14 was clinically useful for the treatment of ABRS and is also suggested that was effective especially for the treatment of ABRS in children caused by beta-lactamase-producing bacteria including M. catarrhalis.
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