PMID- 22070514
OWN - NLM
STAT- MEDLINE
DCOM- 20120517
LR  - 20120119
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 28
IP  - 1
DP  - 2012 Jan
TI  - Safety and effectiveness of azithromycin in the treatment of respiratory 
      infections in children.
PG  - 155-62
LID - 10.1185/03007995.2011.639355 [doi]
AB  - OBJECTIVES: To describe clinical effectiveness of azithromycin in the management 
      of respiratory tract infections in children up to 12 years of age; to examine 
      duration of symptoms after commencement of therapy and to mark adverse events 
      possibly caused by treatment with azithromycin. METHODS: The overall ITT 
      population included 156 children (65 with acute pharyngitis/tonsillitis (AP), 32 
      with acute otitis media (AOM), and 59 with lower respiratory tract infections 
      (LRTI)). Clinical effectiveness was based on results of improvement and cure 
      after 3 day's treatment with azithromycin, calculating the clinical score for 
      each diagnosis before treatment, at the 4th day (end of the therapy) and at the 
      12th or 28th day (end of the study). To better estimate patients' (parents') 
      satisfaction with treatment, a diary was provided for each child and parents 
      recorded the days when a child felt relief of symptoms. RESULTS: In this study 
      azithromycin led to relief of symptoms after 3 days in 89.1% of patients. 
      Antibiotics had been prescribed within 1 year prior to inclusion in 74.4% of 
      patients and 29.5% had previously been treated with macrolides. Clinical 
      effectiveness in the intention-to-treat (ITT) population was 94.8% and there were 
      5.2% failures. Overall, 18 (11.5%) patients reported 25 adverse events (AEs) and 
      nine AEs were characterized as possibly, probably or definitely related to 
      azithromycin. The most common adverse events were diarrhea in nine (5.8%) cases, 
      vomiting in six (3.8%) and abdominal pain reported in four (2.6 %) patients. 
      CONCLUSION: Results of this study show that azithromycin in the treatment of 
      children with respiratory tract infections has high clinical effectiveness and a 
      small number of adverse events. However, major limitations of the study are its 
      design as a non-comparative, observational, postmarketing study and that the 
      etiology of infections was not confirmed. Despite this, it can be concluded that 
      azithromycin is a reliable antibiotic treatment for children's respiratory tract 
      infections, giving fast resolution of symptoms with few adverse events in 
      patients with presumed bacterial infections.
FAU - Lakos, Adela Kolumbic
AU  - Lakos AK
AD  - PLIVA Croatia Ltd., Zagreb, Croatia.
FAU - Pangercic, Ana
AU  - Pangercic A
FAU - Gasparic, Maja
AU  - Gasparic M
FAU - Kukuruzovic, Mirjana Matrapazovski
AU  - Kukuruzovic MM
FAU - Kovacic, Drazen
AU  - Kovacic D
FAU - Barsic, Bruno
AU  - Barsic B
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20111201
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Anti-Bacterial Agents)
RN  - 83905-01-5 (Azithromycin)
SB  - IM
MH  - Anti-Bacterial Agents/adverse effects/therapeutic use
MH  - Azithromycin/*adverse effects/*therapeutic use
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Humans
MH  - Male
MH  - Respiratory Tract Infections/*drug therapy/epidemiology
MH  - Treatment Outcome
EDAT- 2011/11/11 06:00
MHDA- 2012/05/18 06:00
CRDT- 2011/11/11 06:00
PHST- 2011/11/11 06:00 [entrez]
PHST- 2011/11/11 06:00 [pubmed]
PHST- 2012/05/18 06:00 [medline]
AID - 10.1185/03007995.2011.639355 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2012 Jan;28(1):155-62. doi: 10.1185/03007995.2011.639355. Epub 
      2011 Dec 1.