PMID- 18513453
OWN - NLM
STAT- MEDLINE
DCOM- 20080723
LR  - 20211203
IS  - 1471-2431 (Electronic)
IS  - 1471-2431 (Linking)
VI  - 8
DP  - 2008 Jun 2
TI  - Compared to placebo, long-term antibiotics resolve otitis media with effusion 
      (OME) and prevent acute otitis media with perforation (AOMwiP) in a high-risk 
      population: a randomized controlled trial.
PG  - 23
LID - 10.1186/1471-2431-8-23 [doi]
AB  - BACKGROUND: For children at high risk of chronic suppurative otitis media (CSOM), 
      strategies to prevent acute otitis media with perforation (AOMwiP) may reduce 
      progression to CSOM. METHODS: In a double blind study in northern Australia, 103 
      Aboriginal infants with first detection of OME were randomised to receive either 
      amoxicillin (50 mg/kg/d BD) or placebo for 24 weeks, or until bilateral aerated 
      middle ears were diagnosed at two successive monthly examinations (success). 
      Standardised clinical assessments and international standards for microbiology 
      were used. RESULTS: Five of 52 infants in the amoxicillin group and none of 51 
      infants in the placebo group achieved success at the end of therapy (Risk 
      Difference = 9.6% [95% confidence interval 1.6,17.6]). Amoxicillin significantly 
      reduced the proportion of children with i) perforation at the end of therapy (27% 
      to 12% RD = -16% [-31,-1]), ii) recurrent perforation during therapy (18% to 4% 
      RD = -14% [-25,-2]), and iii) reduced the proportion of examinations with a 
      diagnosis of perforation during therapy (20% to 8% adjusted risk ratio 0.36 
      [0.15,0.83] p = 0.017). During therapy, the proportion of examinations with 
      penicillin non-susceptible (MIC > 0.1 microg/ml) pneumococci was not 
      significantly different between the amoxicillin group (34%) and the placebo group 
      (40%). Beta-lactamase positive non-capsular H. influenzae (NCHi) were uncommon 
      during therapy but more frequent in the amoxicillin group (10%) than placebo 
      (5%). CONCLUSION: Aboriginal infants receiving continuous amoxicillin had more 
      normal ears, fewer perforations, and less pneumococcal carriage. There was no 
      statistically significant increase in resistant pneumococci or NCHi in 
      amoxicillin children compared to placebo children who received regular paediatric 
      care and antibiotic treatment for symptomatic illnesses.
FAU - Leach, Amanda J
AU  - Leach AJ
AD  - Menzies School of Health Research, Charles Darwin University, Darwin, Northern 
      Territory, Australia. amanda@menzies.edu.au
FAU - Morris, Peter S
AU  - Morris PS
FAU - Mathews, John D
AU  - Mathews JD
CN  - Chronic Otitis Media Intervention Trial - One (COMIT1) group
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20080602
PL  - England
TA  - BMC Pediatr
JT  - BMC pediatrics
JID - 100967804
RN  - 0 (Anti-Bacterial Agents)
RN  - 804826J2HU (Amoxicillin)
SB  - IM
MH  - Amoxicillin/*administration & dosage
MH  - Anti-Bacterial Agents/*administration & dosage
MH  - Australia
MH  - Bacteria/isolation & purification
MH  - Confidence Intervals
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Microbial Sensitivity Tests
MH  - Nasopharynx/microbiology
MH  - Native Hawaiian or Other Pacific Islander
MH  - Otitis Media with Effusion/complications/*drug therapy/ethnology/microbiology
MH  - Risk Assessment
MH  - Tympanic Membrane Perforation/etiology/*prevention & control
PMC - PMC2443129
FIR - Hayhurst, Bev
IR  - Hayhurst B
FIR - Koops, Harold
IR  - Koops H
FIR - Melder, Angela
IR  - Melder A
FIR - Pulakui, Monica
IR  - Pulakui M
FIR - Stubbs, Liz
IR  - Stubbs L
FIR - Hare, Kim
IR  - Hare K
FIR - Beissbarth, Jemima
IR  - Beissbarth J
FIR - Smith-Vaughan, Heidi
IR  - Smith-Vaughan H
FIR - Stubbs, Liz
IR  - Stubbs L
FIR - Leach, Seija
IR  - Leach S
FIR - Liddle, Robyn
IR  - Liddle R
FIR - Donath, Susan
IR  - Donath S
FIR - Jacklyn, Susan
IR  - Jacklyn S
FIR - McDonnell, Joseph
IR  - McDonnell J
FIR - Bex, Jo
IR  - Bex J
FIR - Hutton, Sue
IR  - Hutton S
FIR - Lukitch, Abe
IR  - Lukitch A
EDAT- 2008/06/03 09:00
MHDA- 2008/07/24 09:00
PMCR- 2008/06/02
CRDT- 2008/06/03 09:00
PHST- 2007/12/14 00:00 [received]
PHST- 2008/06/02 00:00 [accepted]
PHST- 2008/06/03 09:00 [pubmed]
PHST- 2008/07/24 09:00 [medline]
PHST- 2008/06/03 09:00 [entrez]
PHST- 2008/06/02 00:00 [pmc-release]
AID - 1471-2431-8-23 [pii]
AID - 10.1186/1471-2431-8-23 [doi]
PST - epublish
SO  - BMC Pediatr. 2008 Jun 2;8:23. doi: 10.1186/1471-2431-8-23.