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Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: A Randomised Study Comparing Efficacy and Tolerability versus Clindamycin.

Tancawan AL, Pato MN, Abidin KZ, Asari AS, Thong TX, Kochhar P, Muganurmath C, Twynholm M, Barker K - Int J Dent (2015)

Bottom Line: Secondary efficacy results showed a higher clinical success rate at Day 5 in the amoxicillin/clavulanic acid arm.Conclusion.Amoxicillin/clavulanic acid was comparable to clindamycin in achieving clinical success (88.2% versus 89.7%) in acute odontogenic infections and the safety profile was consistent with the known side effects of both drugs.

View Article: PubMed Central - PubMed

Affiliation: Tancawan Dental Clinic, Door 2 Cebu Coliseum Building, Leon Kilat Street, 6000 Cebu City, Philippines.

ABSTRACT
Background. Treatment of odontogenic infections includes surgical drainage and adjunctive antibiotics. This study was designed to generate efficacy and safety data to support twice daily dosing of amoxicillin/clavulanic acid compared to clindamycin in odontogenic infections. Methods. This was a phase IV, randomised, observer blind study; 472 subjects were randomised to receive amoxicillin/clavulanic acid (875 mg/125 mg BID, n = 235) or clindamycin (150 mg QID, n = 237) for 5 or 7 days based on clinical response. The primary endpoint was percentage of subjects achieving clinical success (composite measure of pain, swelling, fever, and additional antimicrobial therapy required) at the end of treatment. Results. The upper limit of two-sided 95% confidence interval for the treatment difference between the study arms (7.7%) was within protocol specified noninferiority margin of 10%, thus demonstrating noninferiority of amoxicillin/clavulanic acid to clindamycin. Secondary efficacy results showed a higher clinical success rate at Day 5 in the amoxicillin/clavulanic acid arm. Most adverse events (raised liver enzymes, diarrhoea, and headache) were similar across both arms and were of mild to moderate intensity. Conclusion. Amoxicillin/clavulanic acid was comparable to clindamycin in achieving clinical success (88.2% versus 89.7%) in acute odontogenic infections and the safety profile was consistent with the known side effects of both drugs. Trial Registration. This trial is registered with Clinicaltrials.gov identifier: NCT02141217.

No MeSH data available.


Related in: MedlinePlus

Study schema. Note: the study had a 1-day screening period (Day 1 to Day 0) during which eligibility was assessed and laboratory tests were performed. Randomisation occurred within 24 hours of screening at baseline (Day 0). Further visits (Day 2, Day 5, and Day 7) were calculated from the baseline/randomisation visit (Day 0).
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fig1: Study schema. Note: the study had a 1-day screening period (Day 1 to Day 0) during which eligibility was assessed and laboratory tests were performed. Randomisation occurred within 24 hours of screening at baseline (Day 0). Further visits (Day 2, Day 5, and Day 7) were calculated from the baseline/randomisation visit (Day 0).

Mentions: A total of 472 subjects were randomised in a 1 : 1 ratio in each of the treatment arms. The study included a one-day screening period followed by a treatment period of five days that could be extended to seven days based on clinical response. Standard surgical intervention for odontogenic infection was permitted only before commencing study treatment. Eligible subjects were randomized on the day of their screening visit or within a day of screening. Efficacy and safety evaluations were performed on Day 2, Day 5, and/or Day 7 (based on treatment duration) (Figure 1). Study treatment included amoxicillin/clavulanic acid (875 mg/125 mg) administered twice daily or clindamycin (150 mg) administered four times daily along with meals for 5 or 7 days. Clinical efficacy (cure (cure was defined as complete resolution of signs and symptoms of infection present at baseline such that no additional antimicrobial therapy was required), improvement (improvement was defined as resolution of fever (if present at baseline) and >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy was required), and failure (failure was defined as inability to improve the signs and symptoms of infection after seven days of therapy so that additional antimicrobial therapy was required)) of the study treatment was assessed based on the response shown by the subjects on the Visual Analogue Scale (VAS) scores of pain and swelling. Since these clinical efficacy parameters were based on symptomatic relief, an optimal study design would have been a double blind design. However, the different dosage regimens and formulations of the study drugs presented practical challenges for a double blind design. Based on these considerations, the study was designed to be an observer blind study with the investigator remaining blinded throughout the study period. An unblinded study team member was appointed for the study for drug dispensing and drug accountability and was also present during the clinic visits to ensure that the investigators remained blinded to treatment assignment. Adherence to the study design requirements was essential and no protocol waivers or exemptions were allowed during the study. This study did not require an independent data safety monitoring board and no interim analysis was performed.


Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: A Randomised Study Comparing Efficacy and Tolerability versus Clindamycin.

Tancawan AL, Pato MN, Abidin KZ, Asari AS, Thong TX, Kochhar P, Muganurmath C, Twynholm M, Barker K - Int J Dent (2015)

Study schema. Note: the study had a 1-day screening period (Day 1 to Day 0) during which eligibility was assessed and laboratory tests were performed. Randomisation occurred within 24 hours of screening at baseline (Day 0). Further visits (Day 2, Day 5, and Day 7) were calculated from the baseline/randomisation visit (Day 0).
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4537712&req=5

fig1: Study schema. Note: the study had a 1-day screening period (Day 1 to Day 0) during which eligibility was assessed and laboratory tests were performed. Randomisation occurred within 24 hours of screening at baseline (Day 0). Further visits (Day 2, Day 5, and Day 7) were calculated from the baseline/randomisation visit (Day 0).
Mentions: A total of 472 subjects were randomised in a 1 : 1 ratio in each of the treatment arms. The study included a one-day screening period followed by a treatment period of five days that could be extended to seven days based on clinical response. Standard surgical intervention for odontogenic infection was permitted only before commencing study treatment. Eligible subjects were randomized on the day of their screening visit or within a day of screening. Efficacy and safety evaluations were performed on Day 2, Day 5, and/or Day 7 (based on treatment duration) (Figure 1). Study treatment included amoxicillin/clavulanic acid (875 mg/125 mg) administered twice daily or clindamycin (150 mg) administered four times daily along with meals for 5 or 7 days. Clinical efficacy (cure (cure was defined as complete resolution of signs and symptoms of infection present at baseline such that no additional antimicrobial therapy was required), improvement (improvement was defined as resolution of fever (if present at baseline) and >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy was required), and failure (failure was defined as inability to improve the signs and symptoms of infection after seven days of therapy so that additional antimicrobial therapy was required)) of the study treatment was assessed based on the response shown by the subjects on the Visual Analogue Scale (VAS) scores of pain and swelling. Since these clinical efficacy parameters were based on symptomatic relief, an optimal study design would have been a double blind design. However, the different dosage regimens and formulations of the study drugs presented practical challenges for a double blind design. Based on these considerations, the study was designed to be an observer blind study with the investigator remaining blinded throughout the study period. An unblinded study team member was appointed for the study for drug dispensing and drug accountability and was also present during the clinic visits to ensure that the investigators remained blinded to treatment assignment. Adherence to the study design requirements was essential and no protocol waivers or exemptions were allowed during the study. This study did not require an independent data safety monitoring board and no interim analysis was performed.

Bottom Line: Secondary efficacy results showed a higher clinical success rate at Day 5 in the amoxicillin/clavulanic acid arm.Conclusion.Amoxicillin/clavulanic acid was comparable to clindamycin in achieving clinical success (88.2% versus 89.7%) in acute odontogenic infections and the safety profile was consistent with the known side effects of both drugs.

View Article: PubMed Central - PubMed

Affiliation: Tancawan Dental Clinic, Door 2 Cebu Coliseum Building, Leon Kilat Street, 6000 Cebu City, Philippines.

ABSTRACT
Background. Treatment of odontogenic infections includes surgical drainage and adjunctive antibiotics. This study was designed to generate efficacy and safety data to support twice daily dosing of amoxicillin/clavulanic acid compared to clindamycin in odontogenic infections. Methods. This was a phase IV, randomised, observer blind study; 472 subjects were randomised to receive amoxicillin/clavulanic acid (875 mg/125 mg BID, n = 235) or clindamycin (150 mg QID, n = 237) for 5 or 7 days based on clinical response. The primary endpoint was percentage of subjects achieving clinical success (composite measure of pain, swelling, fever, and additional antimicrobial therapy required) at the end of treatment. Results. The upper limit of two-sided 95% confidence interval for the treatment difference between the study arms (7.7%) was within protocol specified noninferiority margin of 10%, thus demonstrating noninferiority of amoxicillin/clavulanic acid to clindamycin. Secondary efficacy results showed a higher clinical success rate at Day 5 in the amoxicillin/clavulanic acid arm. Most adverse events (raised liver enzymes, diarrhoea, and headache) were similar across both arms and were of mild to moderate intensity. Conclusion. Amoxicillin/clavulanic acid was comparable to clindamycin in achieving clinical success (88.2% versus 89.7%) in acute odontogenic infections and the safety profile was consistent with the known side effects of both drugs. Trial Registration. This trial is registered with Clinicaltrials.gov identifier: NCT02141217.

No MeSH data available.


Related in: MedlinePlus