title: Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: A Randomised Study Comparing Efficacy and Tolerability versus Clindamycin.
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.
authors: Tancawan Dental Clinic, Door 2 Cebu Coliseum Building, Leon Kilat Street, 6000 Cebu City, Philippines.
authors: Archiel Launch
authors: AL
authors: Tancawan
authors: East Avenue Medical Center, Dental Department, OPD Building, East Avenue, Diliman, 1100 Quezon City, Philippines.
authors: Maria Noemi
authors: MN
authors: Pato
authors: Klinik Pergigian Gunung Rapat, Unit Pakar Periodontik, Jalan Raja Dr. Nazrin Shah, 31350 Ipoh, Perak, Malaysia.
authors: Khamiza Zainol
authors: KZ
authors: Abidin
authors: Klinik Pergigian Cahaya Suria, Unit Periodontik, Tingkat 2, Bangunan Cahaya Suria, Jalan Tun Perak, 50050 Kuala Lumpur, Malaysia.
authors: A S Mohd
authors: AS
authors: Asari
authors: People's Hospital 115, 527 Su Van Hanh Street, District 10, Ho Chi Minh City, Vietnam.
authors: Tran Xuan
authors: TX
authors: Thong
authors: GlaxoSmithKline Asia Pvt. Ltd., 252 Dr Annie Besant Road, Worli, Mumbai 400030, India.
authors: Puja
authors: P
authors: Kochhar
authors: GlaxoSmithKline Pharmaceuticals Ltd., 5 Moore Drive, Research Triangle Park, NC 27709-3398, USA.
authors: Chandra
authors: C
authors: Muganurmath
authors: GlaxoSmithKline Pharmaceuticals Ltd., Stockley Park West, 1-3 Iron Bridge Road, Heathrow, Uxbridge, Middlesex UB11 1BT, UK.
authors: Monique
authors: M
authors: Twynholm
authors: GlaxoSmithKline Pharmaceuticals Ltd., GSK House, 980 Great West Road, Brentford, Middlesex TW8 9GS, UK.
authors: Keith
authors: K
authors: Barker