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Trial record 1 of 26 for:    sinusitis AND Clavulanate
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Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate

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ClinicalTrials.gov Identifier: NCT02340000
Recruitment Status : Completed
First Posted : January 16, 2015
Results First Posted : August 24, 2017
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Paul Sorum, MD, Albany Medical College

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Sinusitis
Interventions: Drug: standard dose amoxicillin/clavulanate
Drug: high dose amoxicillin/clavulanate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard Dose

amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days

standard dose amoxicillin/clavulanate: amoxicillin/clavulanate 875/125 + placebo bid x 7 days

High Dose

Time Period I (November 18, 2014-January 5, 2016): extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets (by different manufacturer) twice a day for 7 days Time Period 2 (February 6, 2016-February 27, 2017): immediate-release amoxicillin/clavunate 875/125 mg plus standard immediate-release amoxicillin 875 mg twice a day for 7 days

high dose amoxicillin/clavulanate: Time Period I: extended-release amoxicillin/clavulanate 1000/62.5 two tablets bid x 7 days Time Period 2: immediate-release amoxicillin/clavulanate 875/125 plus amoxicllin 875 bid x 7 days


Participant Flow for 2 periods

Period 1:   Time Period 1
    Standard Dose   High Dose
STARTED   90   89 
COMPLETED   78   74 
NOT COMPLETED   12   15 
Withdrawal by Subject                6                8 
Lost to Follow-up                6                7 

Period 2:   Time Period 2
    Standard Dose   High Dose
STARTED   69   67 
COMPLETED   50   52 
NOT COMPLETED   19   15 
Withdrawal by Subject                9                7 
Lost to Follow-up                10                8 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard Dose

amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days

standard dose amoxicillin/clavulanate: amoxicillin/clavulanate 875/125 + placebo bid x 7 days

High Dose

Time Period I (November 18, 2014-January 5, 2016): extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets (by different manufacturer) twice a day for 7 days Time Period 2 (February 6, 2016-February 27, 2017): immediate-release amoxicillin/clavunate 875/125 mg plus standard immediate-release amoxicillin 875 mg twice a day for 7 days

high dose amoxicillin/clavulanate: Time Period I: extended-release amoxicillin/clavulanate 1000/62.5 two tablets bid x 7 days Time Period 2: immediate-release amoxicillin/clavulanate 875/125 plus amoxicllin 875 bid x 7 days

Total Total of all reporting groups

Baseline Measures
   Standard Dose   High Dose   Total 
Overall Participants Analyzed 
[Units: Participants]
 159   156   315 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   159   156   315 
   48.0  (15.9)   45.9  (14.8)   46.9  (15.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   159   156   315 
Female      115  72.3%      108  69.2%      223  70.8% 
Male      44  27.7%      48  30.8%      92  29.2% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   0   0   0 
         0 
[1] Race and Ethnicity were not collected from any participant.
Active tobacco use 
[Units: Participants]
Count of Participants
     
Participants Analyzed   159   156   315 
   19   20   39 
COPD/asthma 
[Units: Participants]
Count of Participants
     
Participants Analyzed   159   156   315 
   29   30   59 
allergic rhinitis 
[Units: Participants]
Count of Participants
     
Participants Analyzed   159   156   315 
   82   80   162 
Diabetes 
[Units: Participants]
Count of Participants
     
Participants Analyzed   159   156   315 
   16   15   31 
Heart disease 
[Units: Participants]
Count of Participants
     
Participants Analyzed   159   156   315 
   11   8   19 
History of sinusitis 
[Units: Participants]
Count of Participants
     
Participants Analyzed   159   156   315 
   63   60   123 
Days of illness [1] 
[Units: Days]
Mean (Standard Deviation)
     
Participants Analyzed   159   156   315 
   14.8  (8.8)   14.3  (8.1)   14.5  (8.4) 
[1] Clinician indicated the number of days the patient had been sick prior to the office visit.
Sinusitis category 1 [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   159   156   315 
   101   103   204 
[1] Duration greater than or equal to 10 days
Sinusitis category 2 [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   159   156   315 
   18   19   37 
[1] Severe symptoms (most severe of the 3 categories)
Sinusitis category 3 [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   159   156   315 
   40   34   74 
[1] double sickening
Day 0 SNOT-16 mean item score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed   159   156   315 
   1.89  (.56)   1.99  (.55)   1.94  (.55) 
[1] Ratings on a scale from 0=none to 3=severe of 16 sinusitis-related symptoms. Total score can range from 0 to 48 (with 48 the most severe possible)


  Outcome Measures

1.  Primary:   Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms")   [ Time Frame: end of 3 days of treatment ]

2.  Secondary:   SNOT-16 - Day 3   [ Time Frame: day 0, end of 3 days of treatment ]

3.  Secondary:   Subjective Improvement - Day 10   [ Time Frame: end of 10th day ]

4.  Secondary:   SNOT-16 - Day 10   [ Time Frame: day 0, end of 10th day ]

5.  Secondary:   Nasal Colonization With Resistant Bacteria   [ Time Frame: baseline ]

6.  Secondary:   Willingness to Take the Study Antibiotic in the Future   [ Time Frame: end of 10th day ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  1. Initial formulation of high-dose amox/clav (extended release) became unavailable, so had to switch after participant #180 to immediate-release.
  2. The medical students and residents had trouble reaching some participants for follow-up.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Paul Sorum, MD
Organization: Albany Medical College
phone: 5182627500
e-mail: sorump@mail.amc.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Paul Sorum, MD, Albany Medical College
ClinicalTrials.gov Identifier: NCT02340000     History of Changes
Other Study ID Numbers: 3968
First Submitted: November 22, 2014
First Posted: January 16, 2015
Results First Submitted: July 16, 2017
Results First Posted: August 24, 2017
Last Update Posted: August 24, 2017