Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: A Randomised Study Comparing Efficacy and Tolerability versus Clindamycin
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 phas...
Saved in:
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2015-01-01
|
| Series: | International Journal of Dentistry |
| Online Access: | http://dx.doi.org/10.1155/2015/472470 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832564364428705792 |
|---|---|
| author | Archiel Launch Tancawan Maria Noemi Pato Khamiza Zainol Abidin A. S. Mohd Asari Tran Xuan Thong Puja Kochhar Chandra Muganurmath Monique Twynholm Keith Barker |
| author_facet | Archiel Launch Tancawan Maria Noemi Pato Khamiza Zainol Abidin A. S. Mohd Asari Tran Xuan Thong Puja Kochhar Chandra Muganurmath Monique Twynholm Keith Barker |
| author_sort | Archiel Launch Tancawan |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-dea8537a1991487980fccd4050a726e4 |
| institution | Kabale University |
| issn | 1687-8728 1687-8736 |
| language | English |
| publishDate | 2015-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | International Journal of Dentistry |
| spelling | doaj-art-dea8537a1991487980fccd4050a726e42025-02-03T01:11:17ZengWileyInternational Journal of Dentistry1687-87281687-87362015-01-01201510.1155/2015/472470472470Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: A Randomised Study Comparing Efficacy and Tolerability versus ClindamycinArchiel Launch Tancawan0Maria Noemi Pato1Khamiza Zainol Abidin2A. S. Mohd Asari3Tran Xuan Thong4Puja Kochhar5Chandra Muganurmath6Monique Twynholm7Keith Barker8Tancawan Dental Clinic, Door 2 Cebu Coliseum Building, Leon Kilat Street, 6000 Cebu City, PhilippinesEast Avenue Medical Center, Dental Department, OPD Building, East Avenue, Diliman, 1100 Quezon City, PhilippinesKlinik Pergigian Gunung Rapat, Unit Pakar Periodontik, Jalan Raja Dr. Nazrin Shah, 31350 Ipoh, Perak, MalaysiaKlinik Pergigian Cahaya Suria, Unit Periodontik, Tingkat 2, Bangunan Cahaya Suria, Jalan Tun Perak, 50050 Kuala Lumpur, MalaysiaPeople’s Hospital 115, 527 Su Van Hanh Street, District 10, Ho Chi Minh City, VietnamGlaxoSmithKline Asia Pvt. Ltd., 252 Dr Annie Besant Road, Worli, Mumbai 400030, IndiaGlaxoSmithKline Pharmaceuticals Ltd., 5 Moore Drive, Research Triangle Park, NC 27709-3398, USAGlaxoSmithKline Pharmaceuticals Ltd., Stockley Park West, 1-3 Iron Bridge Road, Heathrow, Uxbridge, Middlesex UB11 1BT, UKGlaxoSmithKline Pharmaceuticals Ltd., GSK House, 980 Great West Road, Brentford, Middlesex TW8 9GS, UKBackground. 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.http://dx.doi.org/10.1155/2015/472470 |
| spellingShingle | Archiel Launch Tancawan Maria Noemi Pato Khamiza Zainol Abidin A. S. Mohd Asari Tran Xuan Thong Puja Kochhar Chandra Muganurmath Monique Twynholm Keith Barker Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: A Randomised Study Comparing Efficacy and Tolerability versus Clindamycin International Journal of Dentistry |
| title | Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: A Randomised Study Comparing Efficacy and Tolerability versus Clindamycin |
| title_full | Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: A Randomised Study Comparing Efficacy and Tolerability versus Clindamycin |
| title_fullStr | Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: A Randomised Study Comparing Efficacy and Tolerability versus Clindamycin |
| title_full_unstemmed | Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: A Randomised Study Comparing Efficacy and Tolerability versus Clindamycin |
| title_short | Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: A Randomised Study Comparing Efficacy and Tolerability versus Clindamycin |
| title_sort | amoxicillin clavulanic acid for the treatment of odontogenic infections a randomised study comparing efficacy and tolerability versus clindamycin |
| url | http://dx.doi.org/10.1155/2015/472470 |
| work_keys_str_mv | AT archiellaunchtancawan amoxicillinclavulanicacidforthetreatmentofodontogenicinfectionsarandomisedstudycomparingefficacyandtolerabilityversusclindamycin AT marianoemipato amoxicillinclavulanicacidforthetreatmentofodontogenicinfectionsarandomisedstudycomparingefficacyandtolerabilityversusclindamycin AT khamizazainolabidin amoxicillinclavulanicacidforthetreatmentofodontogenicinfectionsarandomisedstudycomparingefficacyandtolerabilityversusclindamycin AT asmohdasari amoxicillinclavulanicacidforthetreatmentofodontogenicinfectionsarandomisedstudycomparingefficacyandtolerabilityversusclindamycin AT tranxuanthong amoxicillinclavulanicacidforthetreatmentofodontogenicinfectionsarandomisedstudycomparingefficacyandtolerabilityversusclindamycin AT pujakochhar amoxicillinclavulanicacidforthetreatmentofodontogenicinfectionsarandomisedstudycomparingefficacyandtolerabilityversusclindamycin AT chandramuganurmath amoxicillinclavulanicacidforthetreatmentofodontogenicinfectionsarandomisedstudycomparingefficacyandtolerabilityversusclindamycin AT moniquetwynholm amoxicillinclavulanicacidforthetreatmentofodontogenicinfectionsarandomisedstudycomparingefficacyandtolerabilityversusclindamycin AT keithbarker amoxicillinclavulanicacidforthetreatmentofodontogenicinfectionsarandomisedstudycomparingefficacyandtolerabilityversusclindamycin |