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Efficacy and safety of twice-daily pharmacokinetically enhanced amoxicillin/clavulanate (2000/125 mg) in the treatment of adults with community-acquired pneumonia in a country with a high prevalence of penicillin-resistant Streptococcus pneumoniae.
J Antimicrob Chemother. 2006 Mar; 57(3):536-45.JA

Abstract

OBJECTIVES

This randomized, double-blind, non-inferiority trial evaluated the efficacy and safety of pharmacokinetically enhanced amoxicillin/clavulanate 2000/125 mg twice daily versus amoxicillin/clavulanate 875/125 mg three times daily, both given orally for 7 or 10 days, in the treatment of adults with community-acquired pneumonia in Spain, a country with a high prevalence of penicillin-resistant Streptococcus pneumoniae.

PATIENTS AND METHODS

Following 2:1 randomization, 566 patients (intent-to-treat population) received either amoxicillin/clavulanate 2000/125 mg (n = 374) or amoxicillin/clavulanate 875/125 mg (n = 192).

RESULTS

Among the patients who did not deviate from the protocol (clinical per-protocol population), clinical success at day 21-28 post-therapy (test of cure; primary efficacy endpoint) was 92.4% (266/288) for amoxicillin/clavulanate 2000/125 mg and 91.2% (135/148) for amoxicillin/clavulanate 875/125 mg (treatment difference, 1.1; 95% confidence interval, -4.4, 6.6). Bacteriological success at test of cure in the bacteriology per-protocol population was 90.8% (79/87) with amoxicillin/clavulanate 2000/125 mg and 86.0% (43/50) with amoxicillin/clavulanate 875/125 mg (treatment difference 4.8; 95% confidence interval, -6.6, 16.2). At test of cure, amoxicillin/clavulanate 2000/125 mg was clinically and bacteriologically effective against 7/7 penicillin-resistant Streptococcus pneumoniae (MIC > or = 2 mg/L) isolates (including three amoxicillin non-susceptible strains) and amoxicillin/clavulanate 875/125 mg against 5/5 isolates (including one amoxicillin non-susceptible strain).

CONCLUSIONS

Both treatment regimens were well tolerated. Amoxicillin/clavulanate 2000/125 mg was at least as effective clinically and as safe as amoxicillin/clavulanate 875/125 mg in the treatment of community-acquired pneumonia in adults in a country with a high prevalence of penicillin-resistant S. pneumoniae and has a more convenient twice daily posology.

Authors+Show Affiliations

Emergency Room, Hospital Son Dureta, Palma de Mallorca, Spain.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16446376

Citation

Siquier, B, et al. "Efficacy and Safety of Twice-daily Pharmacokinetically Enhanced Amoxicillin/clavulanate (2000/125 Mg) in the Treatment of Adults With Community-acquired Pneumonia in a Country With a High Prevalence of Penicillin-resistant Streptococcus Pneumoniae." The Journal of Antimicrobial Chemotherapy, vol. 57, no. 3, 2006, pp. 536-45.
Siquier B, Sánchez-Alvarez J, García-Mendez E, et al. Efficacy and safety of twice-daily pharmacokinetically enhanced amoxicillin/clavulanate (2000/125 mg) in the treatment of adults with community-acquired pneumonia in a country with a high prevalence of penicillin-resistant Streptococcus pneumoniae. J Antimicrob Chemother. 2006;57(3):536-45.
Siquier, B., Sánchez-Alvarez, J., García-Mendez, E., Sabriá, M., Santos, J., Pallarés, R., Twynholm, M., & Dal-Ré, R. (2006). Efficacy and safety of twice-daily pharmacokinetically enhanced amoxicillin/clavulanate (2000/125 mg) in the treatment of adults with community-acquired pneumonia in a country with a high prevalence of penicillin-resistant Streptococcus pneumoniae. The Journal of Antimicrobial Chemotherapy, 57(3), 536-45.
Siquier B, et al. Efficacy and Safety of Twice-daily Pharmacokinetically Enhanced Amoxicillin/clavulanate (2000/125 Mg) in the Treatment of Adults With Community-acquired Pneumonia in a Country With a High Prevalence of Penicillin-resistant Streptococcus Pneumoniae. J Antimicrob Chemother. 2006;57(3):536-45. PubMed PMID: 16446376.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of twice-daily pharmacokinetically enhanced amoxicillin/clavulanate (2000/125 mg) in the treatment of adults with community-acquired pneumonia in a country with a high prevalence of penicillin-resistant Streptococcus pneumoniae. AU - Siquier,B, AU - Sánchez-Alvarez,J, AU - García-Mendez,E, AU - Sabriá,M, AU - Santos,J, AU - Pallarés,R, AU - Twynholm,M, AU - Dal-Ré,R, AU - ,, Y1 - 2006/01/30/ PY - 2006/2/1/pubmed PY - 2006/5/11/medline PY - 2006/2/1/entrez SP - 536 EP - 45 JF - The Journal of antimicrobial chemotherapy JO - J Antimicrob Chemother VL - 57 IS - 3 N2 - OBJECTIVES: This randomized, double-blind, non-inferiority trial evaluated the efficacy and safety of pharmacokinetically enhanced amoxicillin/clavulanate 2000/125 mg twice daily versus amoxicillin/clavulanate 875/125 mg three times daily, both given orally for 7 or 10 days, in the treatment of adults with community-acquired pneumonia in Spain, a country with a high prevalence of penicillin-resistant Streptococcus pneumoniae. PATIENTS AND METHODS: Following 2:1 randomization, 566 patients (intent-to-treat population) received either amoxicillin/clavulanate 2000/125 mg (n = 374) or amoxicillin/clavulanate 875/125 mg (n = 192). RESULTS: Among the patients who did not deviate from the protocol (clinical per-protocol population), clinical success at day 21-28 post-therapy (test of cure; primary efficacy endpoint) was 92.4% (266/288) for amoxicillin/clavulanate 2000/125 mg and 91.2% (135/148) for amoxicillin/clavulanate 875/125 mg (treatment difference, 1.1; 95% confidence interval, -4.4, 6.6). Bacteriological success at test of cure in the bacteriology per-protocol population was 90.8% (79/87) with amoxicillin/clavulanate 2000/125 mg and 86.0% (43/50) with amoxicillin/clavulanate 875/125 mg (treatment difference 4.8; 95% confidence interval, -6.6, 16.2). At test of cure, amoxicillin/clavulanate 2000/125 mg was clinically and bacteriologically effective against 7/7 penicillin-resistant Streptococcus pneumoniae (MIC > or = 2 mg/L) isolates (including three amoxicillin non-susceptible strains) and amoxicillin/clavulanate 875/125 mg against 5/5 isolates (including one amoxicillin non-susceptible strain). CONCLUSIONS: Both treatment regimens were well tolerated. Amoxicillin/clavulanate 2000/125 mg was at least as effective clinically and as safe as amoxicillin/clavulanate 875/125 mg in the treatment of community-acquired pneumonia in adults in a country with a high prevalence of penicillin-resistant S. pneumoniae and has a more convenient twice daily posology. SN - 0305-7453 UR - https://www.unboundmedicine.com/medline/citation/16446376/Efficacy_and_safety_of_twice_daily_pharmacokinetically_enhanced_amoxicillin/clavulanate__2000/125_mg__in_the_treatment_of_adults_with_community_acquired_pneumonia_in_a_country_with_a_high_prevalence_of_penicillin_resistant_Streptococcus_pneumoniae_ L2 - https://academic.oup.com/jac/article-lookup/doi/10.1093/jac/dki480 DB - PRIME DP - Unbound Medicine ER -