Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

AUGMENTIN™ in Dental Infections (AUGDENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02141217
Recruitment Status : Completed
First Posted : May 19, 2014
Results First Posted : August 28, 2014
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Focal Infection, Dental Drug: Amoxicillin/clavulanate Drug: Clindamycin Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 472 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 21, 2013
Actual Primary Completion Date : December 28, 2013
Actual Study Completion Date : December 28, 2013


Arm Intervention/treatment
Active Comparator: Amoxicillin/clavulanate
Amoxicillin/ clavulanate 1 g bd for for at least 5 days upto seven days depending on treament response
Drug: Amoxicillin/clavulanate
Amoxicillin/clavulanate 1 g bd for at least 5 days or maximum 7 days depending upon the treatment response.

Active Comparator: Clindamycin
Clindamycin 150 mg qid for at least 5 days or maximum 7 days depending upon treatment response
Drug: Clindamycin
Clindamycin 150 mg qid for at least 5 days or maximum 7 days depending upon the treatment response.




Primary Outcome Measures :
  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) [ Time Frame: Day 5 or Day 7 [End of treatment] ]
    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.


Secondary Outcome Measures :
  1. Number of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at Day 5 [ Time Frame: Day 5 ]
    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.

  2. 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 [ Time Frame: Day 5 ]
    CS is defined as cure or imp in s/sx of odontogenic infections. Cure is defined as the complete resolution of s/sx of infection present at Baseline (BL) and imp is defined as resolution of fever (if present at BL), >70% reduction in swelling and pain and imp in other s/sx such that no additional antimicrobial (ant) therapy is required. In event of cure or imp with complete resolution of fever and >70% reduction in swelling and pain, but 'no change' or 'worsening from BL' in other s/sx (like increased leucocyte count/tooth mobility), the inv's opinion was sought on whether additional ant therapy was required. Par. that required no additional ant therapy were considered a 'success' while those requiring additional ant therapy were deemed a 'failure'. For a sensitivity analysis, all such par. with 'no change' or 'worsening from BL' in these other s/sx were considered as cl failures and termed 'Without Considering Cl Jdg of Inv', even though main s/sx are 'cured' or 'improved'. .

  3. Change From Baseline in the Visual Analogue Scale Assessment of Pain Score at Days 2, 5 and 7 [ Time Frame: Baseline, Days 2, 5 and 7 ]
    Visual Analogue Scale (VAS) is used to measure the amount of pain that the participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain. Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7).

  4. Change From Baseline in Visual Analogue Scale Assessment of Swelling at Days 2, 5 and 7 [ Time Frame: Baseline, Days 2, 5 and 7 ]
    Visual Analogue Scale (VAS) is used to measure the amount of swelling that the participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no swelling and 10 indicates worst possible swelling. Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion Criterion:

    • 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

Exclusion Criteria:

  • 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
  • Female subjects of childbearing potential in whom pregnancy cannot be excluded by a negative pregnancy test and who are not using reliable method of contraception
  • Subjects with lactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption
  • Pregnant or lactating female subjects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141217


Locations
Layout table for location information
Malaysia
GSK Investigational Site
Kuala Lumpur, Malaysia, 50050
GSK Investigational Site
Perak, Malaysia, 31350
GSK Investigational Site
Putrajaya, Malaysia, 62250,
GSK Investigational Site
Selangor, Malaysia, 68100
Philippines
GSK Investigational Site
Cebu, Philippines, 6000
GSK Investigational Site
Davao City, Philippines, 8000
GSK Investigational Site
Quezon, Philippines, 1100
GSK Investigational Site
Quezon, Philippines, 1109
Thailand
GSK Investigational Site
Lampang, Thailand, 52000
GSK Investigational Site
Pranburi,, Thailand, 77120
GSK Investigational Site
Songkhla, Thailand, 90112
Vietnam
GSK Investigational Site
Hanoi, Vietnam, Hoan Kiem District
GSK Investigational Site
Ho Chi Minh City, Vietnam, District 10
GSK Investigational Site
Ho Chi Minh City, Vietnam, District 1
GSK Investigational Site
Ho Chi Minh City, Vietnam, District 5
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 117044
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 117044
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 117044
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 117044
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 117044
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 117044
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02141217     History of Changes
Other Study ID Numbers: 117044
First Posted: May 19, 2014    Key Record Dates
Results First Posted: August 28, 2014
Last Update Posted: September 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Keywords provided by GlaxoSmithKline:
Odontogenic (Dental) Infections
Dental infections, periapical abscess
Bacterial infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Focal Infection, Dental
Focal Infection
Tooth Diseases
Stomatognathic Diseases
Amoxicillin
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors