PMID- 19929975
OWN - NLM
STAT- MEDLINE
DCOM- 20100127
LR  - 20091125
IS  - 1469-0691 (Electronic)
IS  - 1198-743X (Linking)
VI  - 15
IP  - 12
DP  - 2009 Dec
TI  - Single-dose extended-release oral azithromycin vs. 3-day azithromycin for the 
      treatment of group A beta-haemolytic streptococcal pharyngitis/tonsillitis in 
      adults and adolescents: a double-blind, double-dummy study.
PG  - 1103-10
LID - 10.1111/j.1469-0691.2009.02718.x [doi]
AB  - The azithromycin immediate-release formulation (AZ-IR) provides effective 
      treatment for group A beta-haemolytic streptococcal pharyngitis in adults. 
      Single-dose therapy with a novel azithromycin extended-release (AZ-ER) 
      formulation could reduce treatment failure and eliminate non-compliance 
      contributing to antimicrobial resistance. A randomized, double-blind, 
      double-dummy, multicentre trial was conducted comparing AZ-ER (single oral 2-g 
      dose) with AZ-IR (3 days, 500 mg once daily) for the treatment of group A 
      beta-haemolytic streptococcal pharyngitis/tonsillitis in adults and adolescents 
      (n = 598). The primary endpoint was bacteriological eradication at test -of-cure 
      (TOC; day 24-28) in the bacteriological per-protocol population (n = 420). 
      Bacteriological eradication was achieved in 85.4% (175/205) and 81.4% (175/215) 
      of subjects in the AZ-ER and AZ-IR groups, respectively (95% CI -3.1-11.1). 
      Clinical cure at TOC occurred in 99.0% of subjects in the AZ-ER group and in 
      96.7% in the AZ-IR group. At long-term follow-up, bacteriological recurrence was 
      observed in 5.5% (9/163) and 7.7% (12/156), respectively. Both treatments were 
      well tolerated; and most adverse events (AEs) were mild to moderate in intensity. 
      The most frequent treatment-related AE was diarrhoea, or loose stools, in 11% of 
      both treatment groups. AZ-ER-treated and AZ-IR-treated subjects had AE burdens 
      (AE days/patient-year) of 7.6 days and 9.2 days, respectively. A similar trend in 
      favour of AZ-ER was noted for treatment-related diarrhoea burden (1.9 days vs. 
      2.5 days). A single 2-g dose of AZ-ER is as effective and well tolerated as 3 
      days of AZ-IR (500 mg once daily) for treating group A beta-haemolytic 
      streptococcal pharyngitis/tonsillitis in adults and adolescents.
FAU - Jorgensen, D M
AU  - Jorgensen DM
AD  - Pfizer Inc, New London, CT 06320, USA. daniel.m.jorgensen@pfizer.com
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Clin Microbiol Infect
JT  - Clinical microbiology and infection : the official publication of the European 
      Society of Clinical Microbiology and Infectious Diseases
JID - 9516420
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Delayed-Action Preparations)
RN  - 83905-01-5 (Azithromycin)
SB  - IM
MH  - Administration, Oral
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Bacterial Agents/*administration & dosage/therapeutic use
MH  - Azithromycin/*administration & dosage/therapeutic use
MH  - Delayed-Action Preparations
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pharyngitis/*drug therapy/microbiology
MH  - Streptococcal Infections/drug therapy/microbiology
MH  - Streptococcus pyogenes/*drug effects
MH  - Tonsillitis/*drug therapy/microbiology
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2009/11/26 06:00
MHDA- 2010/01/28 06:00
CRDT- 2009/11/26 06:00
PHST- 2009/11/26 06:00 [entrez]
PHST- 2009/11/26 06:00 [pubmed]
PHST- 2010/01/28 06:00 [medline]
AID - S1198-743X(14)64853-9 [pii]
AID - 10.1111/j.1469-0691.2009.02718.x [doi]
PST - ppublish
SO  - Clin Microbiol Infect. 2009 Dec;15(12):1103-10. doi: 
      10.1111/j.1469-0691.2009.02718.x.