Clinical cure rates in subjects treated with azithromycin for community-acquired respiratory tract infections caused by azithromycin-susceptible or azithromycin-resistant Streptococcus pneumoniae: analysis of Phase 3 clinical trial data

Community-acquired respiratory tract infections (CARTI) are commonly caused by Streptococcus pneumoniae (SPN) and empirically treated with azithromycin. This study assessed clinical cure rates in azithromycin-treated subjects with CARTI caused by azithromycin-susceptible (Azi-S) or azithromycin-resi...

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Bibliographic Details
Published in:Journal of antimicrobial chemotherapy 2014-10, Vol.69 (10), p.2835-2840
Main Authors: Zhanel, George G, Wolter, Kevin D, Calciu, Cristina, Hogan, Patricia, Low, Donald E, Weiss, Karl, Karlowsky, James A
Format: Article
Language:English
Subjects:
Adolescent
Adult
Anti-Bacterial Agents - pharmacology
Anti-Bacterial Agents - therapeutic use
Antibiotics
Azithromycin - pharmacology
Azithromycin - therapeutic use
Child
Clinical outcomes
Clinical Trials, Phase III as Topic
Community-Acquired Infections - drug therapy
Community-Acquired Infections - microbiology
Drug resistance
Drug Resistance, Bacterial
Humans
Microbial Sensitivity Tests
Phenotype
Respiratory diseases
Respiratory Tract Infections - drug therapy
Respiratory Tract Infections - microbiology
Streptococcus infections
Streptococcus pneumoniae - drug effects
Treatment Outcome
Young Adult
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Summary:Community-acquired respiratory tract infections (CARTI) are commonly caused by Streptococcus pneumoniae (SPN) and empirically treated with azithromycin. This study assessed clinical cure rates in azithromycin-treated subjects with CARTI caused by azithromycin-susceptible (Azi-S) or azithromycin-resistant (Azi-R) SPN. 1127 subjects with CARTI (402 acute otitis media, 309 community-acquired pneumonia, 255 acute bacterial exacerbations of chronic bronchitis and 161 acute bacterial sinusitis) in 13 Phase 3 clinical trials (1993-2007) had a confirmed pathogen, received azithromycin and were assessed for clinical cure/failure. 34.4% of subjects (388/1127) had a positive culture for SPN; 33.4% (376/1127) had Azi-S or Azi-R SPN. 28.9% (112/388) of subjects with SPN had Azi-R SPN: 35.7% (40/112) were low-level Azi-R SPN (LLAR; MIC 2-8 mg/L), while 64.3% (72/112) were high-level Azi-R SPN (HLAR; MIC ≥16 mg/L). Among Azi-S and Azi-R SPN CARTI subjects, clinical cure rates were: 86.2% (324/376) overall; 89.4% (236/264) for subjects with Azi-S SPN; 78.6% (88/112) for subjects with Azi-R SPN (P = 0.003, versus Azi-S); 77.5% (31/40) for subjects with LLAR SPN (P 
ISSN:0305-7453
1460-2091
DOI:10.1093/jac/dku207