EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
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)
Timeframe: Day 5 or Day 7 [End of treatment]
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)
Timeframe: Day 5 or Day 7 [End of treatment]
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)
Timeframe: Day 5 or Day 7 [End of treatment]
Secondary outcomes:
Number of participants achieving clinical success (cure or improvement) considering clinical judgment of the investigator at Day 5
Timeframe: 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
Timeframe: Day 5
Change from Baseline in the Visual Analogue Scale assessment of pain score at Days 2, 5 and 7
Timeframe: Baseline, Days 2, 5 and 7
Change from Baseline in Visual Analogue Scale assessment of swelling at Days 2, 5 and 7
Timeframe: Baseline, Days 2, 5 and 7
Interventions:
Drug: Amoxicillin/clavulanate
Drug: Clindamycin
Enrollment:
472
Observational study model:
Not applicable
Primary completion date:
2013-28-12
Time perspective:
Not applicable
Clinical publications:
Kochhar P, Muganurmath C, Twynholm M, Barker K, Tancawan AL, Pato MN, Abidin K, Asari ASBM, Xuan TT. Amoxicillin/clavulanic acid for the treatment of odontogenic infections: A randomised study comparing efficacy and tolerability versus clindamycin. Int J Dent. 2015;2015:
Medical condition
Focal Infection, Dental
Product
amoxicillin/clavulanic acid, clindamycin
Collaborators
Not applicable
Study date(s)
March 2013 to December 2013
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
No
- Inclusion Criterion:
- Adult (≥18 years of age) males and females
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Inclusion Criterion:
Exclusion criteria:
- 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
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.
Trial location(s)
Location
GSK Investigational Site
Ho Chi Minh City, Vietnam, District 10
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2013-28-12
Actual study completion date
2013-28-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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