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

Amanda Leach, Peter Morris, J Mathews, Chronic otitis media interventiontrial–one (comit1) group

    Research output: Contribution to journalArticleResearchpeer-review

    Abstract

    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. � 2008 Leach et al; licensee BioMed Central Ltd.
    Original languageEnglish
    Pages (from-to)1-9
    Number of pages9
    JournalBMC Pediatrics
    Volume8
    Issue number23
    Publication statusPublished - 2008

    Fingerprint

    Otitis Media with Effusion
    Amoxicillin
    Otitis Media
    Randomized Controlled Trials
    Placebos
    Anti-Bacterial Agents
    Population
    Suppurative Otitis Media
    Streptococcus pneumoniae
    Human Influenza
    Therapeutics
    Middle Ear
    beta-Lactamases
    Microbiology
    Double-Blind Method
    Penicillins
    Ear
    Odds Ratio
    Confidence Intervals
    Pediatrics

    Cite this

    @article{468fda9653d84d0d9629de0a3a63a647,
    title = "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",
    abstract = "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. � 2008 Leach et al; licensee BioMed Central Ltd.",
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    author = "Amanda Leach and Peter Morris and J Mathews and {Chronic otitis media interventiontrial{\^a}€“one (comit1) group}",
    year = "2008",
    language = "English",
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    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. / Leach, Amanda; Morris, Peter; Mathews, J; Chronic otitis media interventiontrial–one (comit1) group.

    In: BMC Pediatrics, Vol. 8, No. 23, 2008, p. 1-9.

    Research output: Contribution to journalArticleResearchpeer-review

    TY - JOUR

    T1 - 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

    T2 - A randomized controlled trial

    AU - Leach, Amanda

    AU - Morris, Peter

    AU - Mathews, J

    AU - Chronic otitis media interventiontrial–one (comit1) group, null

    PY - 2008

    Y1 - 2008

    N2 - 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. � 2008 Leach et al; licensee BioMed Central Ltd.

    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. � 2008 Leach et al; licensee BioMed Central Ltd.

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    KW - antiinfective agent

    KW - Aborigine

    KW - acute otitis media

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    KW - female

    KW - Haemophilus influenzae

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    KW - Confidence Intervals

    KW - Double-Blind Method

    KW - Drug Administration Schedule

    KW - Humans

    KW - Infant

    KW - Infant, Newborn

    KW - Microbial Sensitivity Tests

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    KW - Risk Assessment

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    VL - 8

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    JO - BMC Pediatrics

    JF - BMC Pediatrics

    SN - 1471-2431

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