AUGMENTIN™ in Dental Infections
AUGDENT
Efficacy, Safety and Tolerability of Amoxicillin + Clavulanic Acid (875mg/125mg) Two Times a Day Compared to Clindamycin (150mg) Four Times a Day for 5-7 Days in Treatment of Acute Odontogenic Infection With or Without Abscess
1 other identifier
interventional
472
4 countries
15
Brief Summary
In clinical practice, amoxicillin + clavulanic acid is widely used in the treatment of odontogenic infection. Therefore, this study is designed to generate data to support its use by demonstrating efficacy, safety and tolerability in comparison with clindamycin in subjects with acute odontogenic infections with or without abscess. This will be a two-arm, parallel, comparative, observer blind, randomised study to assess efficacy, safety and tolerability of amoxicillin + clavulanic acid (875mg/125mg) in comparison with clindamycin (150mg) administered for 5-7 days in subjects with acute odontogenic infections with or without abscess. The study will be performed in adult subjects both male and female ≥18 years of age who present with acute odontogenic infections. A total of 472 subjects will be randomized in 1:1 ratio, i.e. 236 subjects in each treatment arm. The treatment duration of the study will be at least 5 days or maximum 7 days depending upon the treatment response. Subjects will be assessed on Day 5 and if Investigator feels the need of continuing the treatment at Day 5 then treatment will be continued till Day 7. For subjects who do not show treatment response on Day 5, assessments will be performed on Day 7.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2013
Shorter than P25 for phase_4
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2013
CompletedFirst Submitted
Initial submission to the registry
May 15, 2014
CompletedFirst Posted
Study publicly available on registry
May 19, 2014
CompletedResults Posted
Study results publicly available
August 28, 2014
CompletedSeptember 25, 2017
August 1, 2017
9 months
May 15, 2014
August 14, 2014
August 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at the End of Treatment (Day 5 or Day 7)
Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), \>70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.
Day 5 or Day 7 [End of treatment]
Secondary Outcomes (4)
Number of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at Day 5
Day 5
Number of Participants (Par.) Achieving Clinical Success (CS) (Cure or Improvement [Imp] in Signs [s] and Symptoms [sx] [s/sx]) Without Considering Clinical (cl) Judgment (Jdg) of the Investigator (Inv) at Day 5
Day 5
Change From Baseline in the Visual Analogue Scale Assessment of Pain Score at Days 2, 5 and 7
Baseline, Days 2, 5 and 7
Change From Baseline in Visual Analogue Scale Assessment of Swelling at Days 2, 5 and 7
Baseline, Days 2, 5 and 7
Study Arms (2)
Amoxicillin/clavulanate
ACTIVE COMPARATORAmoxicillin/ clavulanate 1 g bd for for at least 5 days upto seven days depending on treament response
Clindamycin
ACTIVE COMPARATORClindamycin 150 mg qid for at least 5 days or maximum 7 days depending upon treatment response
Interventions
Amoxicillin/clavulanate 1 g bd for at least 5 days or maximum 7 days depending upon the treatment response.
Clindamycin 150 mg qid for at least 5 days or maximum 7 days depending upon the treatment response.
Eligibility Criteria
You may qualify if:
- Adult (≥18 years of age) males and females
- Subjects with diagnosis of acute odontogenic infections of following types requiring antibiotic therapy
- Periapical abscess
- Aute periodontitis
- Pericoronitis • Provision of voluntary written informed consent
You may not qualify if:
- Subjects presenting with complications like osteomyelitis, dentocutaneous fistula, dentoalveolar fistula, draining sinus, facial-space swelling, necrotizing fasciitis OR subjects requiring hospitalization, aggressive intravenous antimicrobial therapy, requiring local application of antimicrobials for the treatment of odontogenic infection.
- Subjects presenting with odontogenic infections secondary to traumatic injury to the face.
- Subjects with valvular heart disease, prosthetic heart valves, congenital heart disease or any other conditions prone to infective endocarditis
- Subjects with a known clinically significant abnormality identified at screening on physical examination or known laboratory tests which, in the judgment of the Investigator, would preclude safe completion of the study
- Subject who has taken a systemic antibiotic within 2 weeks before study drug administration or a long-acting injectable antibiotic (e.g., penicillin G benzathine) within 4 weeks before study drug administration
- Immunocompromised subjects or subjects on immunosuppressants or systemic corticosteroids
- Subjects with chronic gingivitis or chronic periodontitis
- Subjects with uncontrolled diabetes mellitus or HIV infection
- History of hypersensitivity or allergic reactions to any beta-lactam such as penicillin, cephalosporin, moxicillin/clavulanic acid or clindamycin
- Concomitant infection, that requires additional antimicrobial therapy during the study period
- Subjects with clinically significant liver disease as defined by alanine aminotransferase (ALT) or aspartate minotransferase (AST) levels \>2.5 times the upper limit of normal (ULN) or a diagnosis of chronic active hepatitis including that of viral etiology, or on antiviral or immunosuppressive therapy.
- Subjects with renal impairment with serum creatinine \> 1.7 mg/dl in men and \>1.5mg/dl in women.
- Subjects with infectious mononucleosis
- Subjects with history of documented Clostridium difficile-associated diarrhoea or existing diarrhoea
- Concomitant treatment with oral anticoagulants, methotrexate or probenicid
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (15)
GSK Investigational Site
Kuala Lumpur, 50050, Malaysia
GSK Investigational Site
Kuala Selangor, 68100, Malaysia
GSK Investigational Site
Perak, 31350, Malaysia
GSK Investigational Site
Putrajaya, 62250,, Malaysia
GSK Investigational Site
Cebu, 6000, Philippines
GSK Investigational Site
Davao City, 8000, Philippines
GSK Investigational Site
Quezon, 1100, Philippines
GSK Investigational Site
Quezon, 1109, Philippines
GSK Investigational Site
Lampang, 52000, Thailand
GSK Investigational Site
Pran Buri, 77120, Thailand
GSK Investigational Site
Songkhla, 90112, Thailand
GSK Investigational Site
Hanoi, Hoan Kiem District, Vietnam
GSK Investigational Site
Ho Chi Minh City, District 10, Vietnam
GSK Investigational Site
Ho Chi Minh City, District 1, Vietnam
GSK Investigational Site
Ho Chi Minh City, District 5, Vietnam
Related Publications (1)
Tancawan AL, Pato MN, Abidin KZ, Asari AS, Thong TX, Kochhar P, Muganurmath C, Twynholm M, Barker K. Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: A Randomised Study Comparing Efficacy and Tolerability versus Clindamycin. Int J Dent. 2015;2015:472470. doi: 10.1155/2015/472470. Epub 2015 Aug 2.
PMID: 26300919DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2014
First Posted
May 19, 2014
Study Start
March 21, 2013
Primary Completion
December 28, 2013
Study Completion
December 28, 2013
Last Updated
September 25, 2017
Results First Posted
August 28, 2014
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.