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Amoxicillin-clavulanate: Proven efficacy in community-acquired bacterial infections

Choose the confidence of Augmentin, your reliable partner in tackling common community-acquired bacterial infections.

Click on an indication

to find out more about the efficacy recommending amoxicillin-clavulanate in the following indications:

 

  • Acute Otitis Media (AOM)

    Amoxicillin-clavulanate can effectively tackle resistant pathogens causing AOM1

    • Children (age 6-30 months) with bacterial AOM were randomised to receive either amoxicillin-clavulanate (90/6.4 mg/kg/day in 2 divided doses for 10 days) or azithromycin (10 mg/kg for 1 day followed by 5 mg/kg/day for 4 days).1
    • Amoxicillin-clavulanate was shown to clinically achieve a higher rate of treatment success and eradication of resistant strains compared with azithromycin.1

    End-of-treatment clinical success

    Bacterial eradication

    PSRP: Penicillin-resistant Streptococcus pneumoniae.

  • Recurrent Tonsillopharyngitis

    Amoxicillin-clavulanate promotes fast recovery from recurrent tonsillopharyngitis by eradicating Streptococcus pyogenes2

    • Children aged 2–14 years (n = 51) were randomised to receive either oral phenoxymethylpenicillin (40–60 mg/kg/day in 3 divided doses) or oral amoxicillin-clavulanate (20–40 mg/kg/day in 3 divided doses) for 10 days.2
    • Amoxicillin-clavulanate achieved higher bacterial eradication than phenoxymethylpenicillin.2

    Bacteriological eradication

  • Community-Acquired Pneumonia (CAP)

    Amoxicillin-clavulanate has proven efficacy comparable to commonly used antibiotics in bacterial CAP3-5

    • Hospitalised adult patients were randomised to receive either levofloxacin 500 mg intravenous (IV) once every 24 hours (q24h) followed by 500 mg orally q24h or amoxicillin-clavulanate 500 mg/100 mg IV once every 8 hours (q8h) plus oral clarithromycin 500 mg once every 12 hours (q12h) followed by oral amoxicillin-clavulanate 250 mg/125 mg q8h plus oral clarithromycin 500 mg q12h for 7-14 days.3
    • Amoxicillin-clavulanate (+ clarithromycin) shows similar clinical response rate to levofloxacin in hospitalised adult patients with CAP.3

    Clinical response

    capstart_study_2015

    β-lactam monotherapy is noninferior to a combination with either a β-lactam + macrolide or fluoroquinolone monotherapy, in 90-day mortality among patients with clinically suspected CAP admitted to non-ICU wards4

    meta_analysis_2019

    No significant difference in clinical success, microbiological treatment success and length of stay between fluoroquinolone monotherapy and β-lactam with or without macrolide, in hospitalised (non-ICU) CAP patients5

     

  • Acute Exacerbations of COPD (AE COPD)

    Amoxicillin-clavulanate can prolong the time to the next exacerbation in mild to moderate bacterial AE COPD6

    • In a multicenter, parallel, double-blind, placebo-controlled trial, participants were randomised to receive either amoxicillin-clavulanate 500/125 mg or placebo three times daily for 8 days.6
    • In ambulatory exacerbations of mild-to moderate AE COPD, amoxicillin-clavulanate was more effective and significantly prolonged the time to the next exacerbation, compared with placebo.6

    % patients cured at EOT

    EOT: End of treatment.

    Prolonged time to the next exacerbation vs placebo

    AMC: Amoxicillin-clavulanate; TID: Three times a day.

    Amoxicillin-clavulanate demonstrates clinical efficacy comparable to moxifloxacin in managing AE COPD7

    • In a randomised, double-blind outpatient study, patients received either moxifloxacin 400 mg once daily for 5 days or amoxicillin-clavulanate 875/125 mg twice daily for 7 days.7
    • Amoxicillin-clavulanate demonstrated clinical efficacy comparable to moxifloxacin in managing AE COPD.7

    Primary endpoint: Clinical failure rates at 8 weeks
    in mild to moderate AE COPD

    BID: Twice a day; QD: Once a day.

  • Skin and Soft Tissue Infections (SSTI)

    Amoxicillin-clavulanate has proven efficacy in SSTI

    • In a prospective, randomised, open-label, parallel-group, multinational study the efficacy of sequential IV/oral moxifloxacin 400 mg OD, and IV amoxicillin-clavulanate 1000 mg/200 mg TID followed by oral amoxicillin-clavulanate 500 mg/125 mg TID, for 7–21 days in hospitalised patients with complicated skin and skin structure infections, was compared.8
    • Amoxicillin-clavulanate showed clinical response comparable to moxifloxacin.8

    Clinical response

    • In another study, 200 children with SSTI (impetigo, ecthyma, folliculitis, furunculosis, periporitis, and infected scabies were randomised to receive a suspension of amoxicillin-clavulanate 125 mg/30 mg per 5 ml, in a dose equivalent to amoxicillin 20 mg/kg/day in 3 divided doses (n=50), or erythromycin 30 mg/kg/day in 4 divided doses (n = 50) for 10 days or amoxicillin 20 mg/kg/day in divided doses (n = 50) for 10 days, and co-trimoxazole (trimethoprim 8 mg/kg/day + sulphamethoxazole 40 mg/kg/day) (N = 50) in 2 divided doses for 10 days.9
    • Amoxicillin-clavulanate showed clinical success in children with mild to moderate pyoderma.9

    Clinical efficacy

 

 

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References

  1. Hoberman A, Dagan R, Leibovitz E, et al. Large dosage amoxicillin/clavulanate, compared with azithromycin, for the treatment of bacterial acute otitis media in children. Pediatr Infect Dis J 2005;24(6):525–532.
  2. Asensi F, López-Hontangas JL, Otero M, et al. [Comparison between penicillin and amoxicillin-clavulanic acid for the treatment of recurrent tonsillopharyngitis in childhood]. Rev Esp Quimioter 1999;12(3):211214.
  3. Lin T-Y, Lin S-M, Chen H-C, et al. An Open-label, Randomized Comparison of Levofloxacin and Amoxicillin/Clavulanate plus Clarithromycin for the Treatment of Hospitalized Patients with Community-acquired Pneumonia. Chang Gung Med J 2007;30(4):32132.
  4. Postma DF, van Werkhoven CH, van Elden LJR, et al. CAP-START Study Group. Antibiotic treatment strategies for community-acquired pneumonia in adults. N Engl J Med. 2015;372(14):1312-23.
  5. Liu S, Tong X, Ma Y, et al. Respiratory Fluoroquinolones Monotherapy vs. β-Lactams With or Without Macrolides for Hospitalized Community-Acquired Pneumonia Patients: A Meta-Analysis. Front Pharmacol. 2019;10:489.
  6. Llor C, Moragas A, Hernández S, Bayona C, Miravitlles M. Efficacy of antibiotic therapy for acute exacerbations of mild to moderate chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2012;186(8):716-23.
  7. Wilson R, Anzueto A, Miravitlles M, et al. Moxifloxacin versus amoxicillin/clavulanic acid in outpatient acute exacerbations of COPD:MAESTRAL results. Eur Respir J 2012;40(1):17-27.
  8. Vick-Fragoso R, Hernández-Oliva G, Cruz-Alcázar J, et al. Efficacy and safety of sequential intravenous/oral moxifloxacin vs intravenous/oral amoxicillin/clavulanate for complicated skin and skin structure infections. Infection 2009;37(5):407–417.
  9. Kar PK. Use of amoxicillin and clavulanic acid (Augmentin) in the treatment of skin and soft tissue infections in children. Med J Armed Forces India 1997;53(2):87–90.

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Augmentin is a registered trademark of the GlaxoSmithKline group of companies.

PM-RCH-ACA-WCNT-230005 | Approval date: January 2024. Expiration date: January 2026