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Trial record 54 of 232 for:    clindamycin

AUGMENTIN™ in Dental Infections (AUGDENT)

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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

Tracking Information
First Submitted Date  ICMJE May 15, 2014
First Posted Date  ICMJE May 19, 2014
Results First Submitted Date  ICMJE August 14, 2014
Results First Posted Date  ICMJE August 28, 2014
Last Update Posted Date September 25, 2017
Actual Study Start Date  ICMJE March 21, 2013
Actual Primary Completion Date December 28, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2014)
Clinical Success at End of Treatment [ Time Frame: EOT (day 5/7) ]
• Percentage of subjects achieving clinical success (cure or improvement) at end of treatment (Day 5/7)
Change History Complete list of historical versions of study NCT02141217 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2014)
  • 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.
  • 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'. .
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2014)
  • Clinical success at Day 5 [ Time Frame: 5 days ]
    • Percentage of subjects achieving clinical success at Day 5
  • Change in Visual analogue Scale for Pain [ Time Frame: Day 2,5 and 7 ]
    • Change in score on Visual Analogue Scale for assessment of pain from baseline to Day 2, 5 and 7
  • Visual analogue Scale for Swelling [ Time Frame: Day 2, 5 and 7 ]
    • Change in score on Visual Analogue Scale for assessment of swelling from baseline to Day 2, 5 and 7
  • Adverse Events [ Time Frame: Day 7 ]
    Percentage of subjects having adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AUGMENTIN™ in Dental Infections
Official Title  ICMJE 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
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.
Detailed Description

This two-arm, parallel, comparative, observer blind, randomised study will be performed in adult subjects both male and female ≥18 years of age who present with acute odontogenic infection with or without abscess. A total of 472 subjects will be randomised in 1:1 ratio to get 205 evaluable subjects in each study arm. After obtaining informed consent, subject will undergo surgical intervention including surgical incisions, drainages, removal of the involved tooth, debridement, puncture lavage or trephination, if deemed necessary by the Investigator. These surgical interventions will be performed before the start of study treatment. On Day 0 after confirming the eligibility, subjects will be randomised to either of the study arms. The treatment duration of the study will be at least 5 days which may increase to 7 days, if Investigator feels the need of continuing the treatment at Day 5. In such cases clinical assessment will be done again at Day 7. Thus the efficacy evaluation will be performed at baseline (Day 0) prior to study drug administration and on Day 5 and/ or 7. Safety laboratory evaluations will be performed at Screening Visit and will be repeated at end of study treatment i.e. either on Day 5 or Day 7. On Baseline, Day 2, Day 5 and/ or Day 7, Visual Analogue Scale (VAS) will be used to measure amount of pain and swelling that a subject will experience. This scale has numerical ratings from 0 to 10. Zero would mean "No pain" and 10 would mean "Worst possible pain". The subject will be asked to choose the most appropriate score on VAS which best describes his/her pain status over last 24 hours. While using VAS for swelling, zero would mean "No swelling" and 10 would mean "Maximum possible swelling". The Investigator will choose the most appropriate score on VAS which best describes subject's swelling.

Sample for microbiological culture will be obtained at the discretion of Investigator while performing the surgical procedure. When microbiological culture is indicated and feasible, two sets (each consisting of aerobic and anaerobic media) will be obtained. This sampling will be done in approximately 80 subjects randomly who will provide consent at Screening. The sample will be collected and dispatched in appropriate transport medium to the central laboratory for culture and antibiotic susceptibility.

Protocol waivers or exemptions will not be allowed.

The total duration of each subject's participation will be 6-9 days including Screening period of 0-1 day (Day -1 to Day 0) and Treatment period of 5-7 days (Day 0 to Day 5-7).

The primary objective of the study is to compare clinical efficacy (cure and improvement) of both the treatment arms which uses VAS for assessment of pain and swelling. Since the clinical efficacy parameters are subjective, it is mandatory to keep the observer/Investigator blinded during the study assessment. In addition, designing blinded study is challenging owing to different dosage regimen and formulation of study drugs. The study design of double blind double dummy is not recommended in view of increased pill burden which in turn can have an impact on treatment compliance. The possibility of over-encapsulation is ruled out due to large pill size of amoxicillin + clavulanic acid. Therefore to maintain blinding of Investigators, the study is designed as observer blind with Investigator remaining blinded throughout the study period. An unblinded study team member will be appointed for each site who will be involved in dispensing of the study drugs to subjects. The unblinded study team member will remain present during subject assessment for all study visits and will ensure that Investigator remains blinded to treatment assignment.

Study treatment includes amoxicillin + clavulanic acid (875mg/125mg) two times daily or clindamycin (150mg) four times daily for 5-7 days both administered orally with meal. Augmentin™ (amoxicillin + clavulanic acid) from GSK and Dalacin-C (clindamycin) from Pfizer will be used as study treatments. The contents of the label will be in accordance with all applicable regulatory requirements.

Patients can receive additional medical therapy such as analgesics or anti-inflammatory drugs. However, opioid analgesics and any other antibiotic apart from study drugs will not be permitted during entire study period.

This study will be conducted in accordance with ICH GCP, all applicable subject privacy requirements, and the ethical principles that are outlined in the Declaration of Helsinki 2008, including IRB/ IEC review and approval of study protocol and any subsequent amendments, subject informed consent and Investigator reporting requirements.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Focal Infection, Dental
Intervention  ICMJE
  • Drug: Amoxicillin/clavulanate
    Amoxicillin/clavulanate 1 g bd for at least 5 days or maximum 7 days depending upon the treatment response.
  • Drug: Clindamycin
    Clindamycin 150 mg qid for at least 5 days or maximum 7 days depending upon the treatment response.
Study Arms  ICMJE
  • Active Comparator: Amoxicillin/clavulanate
    Amoxicillin/ clavulanate 1 g bd for for at least 5 days upto seven days depending on treament response
    Intervention: Drug: Amoxicillin/clavulanate
  • Active Comparator: Clindamycin
    Clindamycin 150 mg qid for at least 5 days or maximum 7 days depending upon treatment response
    Intervention: Drug: Clindamycin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2014)
472
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 28, 2013
Actual Primary Completion Date December 28, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia,   Philippines,   Thailand,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02141217
Other Study ID Numbers  ICMJE 117044
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP