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The aim is to determine if high-dose amoxicillin/clavulanate is more effective than standard-dose amoxicillin/clavulanate in treating acute bacterial sinusitis in adults seen at a primary care office.
The aim was amended in February 2016--because of the unexpected unavailability of the original high-dose formulation of amoxicillin/clavulanate--to compare the effectiveness (versus standard dose) of extended-release (the original formulation) versus immediate-release amoxicillin/clavulanate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard dose | Active Comparator | amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days |
|
| high dose | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard dose amoxicillin/clavulanate | Drug | amoxicillin/clavulanate 875/125 + placebo bid x 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms") | rating of "a lot better" or "no symptoms" | end of 3 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| SNOT-16 - Day 3 | 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) of the 16 symptoms. The outcome measure was the mean difference in the ratings of each of the 16 symptoms between day 0 and day 3 (values at day 0 minus values at day 3). | day 0, end of 3 days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany Medical Center Internal Medicine and Pediatrics | Latham | New York | 12110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22438350 | Background | Chow AW, Benninger MS, Brook I, Brozek JL, Goldstein EJ, Hicks LA, Pankey GA, Seleznick M, Volturo G, Wald ER, File TM Jr; Infectious Diseases Society of America. IDSA clinical practice guideline for acute bacterial rhinosinusitis in children and adults. Clin Infect Dis. 2012 Apr;54(8):e72-e112. doi: 10.1093/cid/cir1043. Epub 2012 Mar 20. | |
| 29738561 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Time Period 1 |
|
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| Time Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | High Dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms") | rating of "a lot better" or "no symptoms" | The number of participants who gave ratings at the end of day 3 of treatment | Posted | Count of Participants | Participants | end of 3 days of treatment |
|
10 days
The number of participants reporting adverse effects was less than the number initially at risk because some patients withdrew before starting treatment or were lost to follow-up for the study. Since they were all patients in our practice, however, we knew--outside of the study---that none of them suffered death or other serious adverse effects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Dose Time Period I | amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginitis | Infections and infestations | Systematic Assessment | vaginal itching or discharge at day 3 |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Sorum, MD | Albany Medical College | 5182627500 | sorump@mail.amc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2014 | Jul 7, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 28, 2014 | Jul 16, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D019818 | Clavulanic Acid |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| high dose amoxicillin/clavulanate | Drug | 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 |
|
| Subjective Improvement - Day 10 | rating of "a lot better" or "no symptoms" | end of 10th day |
| SNOT-16 - Day 10 | 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) of the 16 symptoms. The outcome measure was the mean difference in the ratings of each of the 16 symptoms between day 0 and day 10 (values at day 0 minus values at day 10). | day 0, end of 10th day |
| Nasal Colonization With Resistant Bacteria | Clinicians performed anterior nasal cultures to look for colonization with penicillin-resistant pneumococci and other pathogens (stopped after participant #231 because of lack of funds). | baseline |
| Willingness to Take the Study Antibiotic in the Future | whether participants said they would NOT take the antibiotic again | end of 10th day |
| Matho A, Mulqueen M, Tanino M, Quidort A, Cheung J, Pollard J, Rodriguez J, Swamy S, Tayler B, Garrison G, Ata A, Sorum P. High-dose versus standard-dose amoxicillin/clavulanate for clinically-diagnosed acute bacterial sinusitis: A randomized clinical trial. PLoS One. 2018 May 8;13(5):e0196734. doi: 10.1371/journal.pone.0196734. eCollection 2018. |
| NOT COMPLETED |
|
|
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Active tobacco use | Count of Participants | Participants |
|
| COPD/asthma | Count of Participants | Participants |
|
| allergic rhinitis | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Heart disease | Count of Participants | Participants |
|
| History of sinusitis | Count of Participants | Participants |
|
| Days of illness | Clinician indicated the number of days the patient had been sick prior to the office visit. | Mean | Standard Deviation | days |
|
| Sinusitis category 1 | Duration greater than or equal to 10 days | Count of Participants | Participants |
|
| Sinusitis category 2 | Severe symptoms (most severe of the 3 categories) | Count of Participants | Participants |
|
| Sinusitis category 3 | double sickening | Count of Participants | Participants |
|
| Day 0 SNOT-16 mean item score | 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) | Mean | Standard Deviation | units on a scale |
|
| OG002 | Standard Dose Time Period 2 | Amoxicillin/clavulnate 875/125 plus placebo bid x 7 days |
| OG003 | High Dose Time Period 2 | immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875 |
|
|
| Secondary | SNOT-16 - Day 3 | 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) of the 16 symptoms. The outcome measure was the mean difference in the ratings of each of the 16 symptoms between day 0 and day 3 (values at day 0 minus values at day 3). | The number of participants who gave ratings at day 3. | Posted | Mean | Standard Deviation | units on a scale | day 0, end of 3 days of treatment |
|
|
|
| Secondary | Subjective Improvement - Day 10 | rating of "a lot better" or "no symptoms" | The number of participants who gave a rating at day 10. | Posted | Count of Participants | Participants | end of 10th day |
|
|
|
| Secondary | SNOT-16 - Day 10 | 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) of the 16 symptoms. The outcome measure was the mean difference in the ratings of each of the 16 symptoms between day 0 and day 10 (values at day 0 minus values at day 10). | The number of participants who gave ratings at day 10. | Posted | Mean | Standard Deviation | units on a scale | day 0, end of 10th day |
|
|
|
| Secondary | Nasal Colonization With Resistant Bacteria | Clinicians performed anterior nasal cultures to look for colonization with penicillin-resistant pneumococci and other pathogens (stopped after participant #231 because of lack of funds). | All 231 participants were analyzed together regardless of treatment. | Posted | Count of Participants | Participants | baseline |
|
|
|
| Secondary | Willingness to Take the Study Antibiotic in the Future | whether participants said they would NOT take the antibiotic again | Posted | Count of Participants | Participants | end of 10th day |
|
|
|
| 0 |
| 90 |
| 0 |
| 90 |
| 30 |
| 87 |
| EG001 | High Dose Time Period 1 | extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days | 0 | 89 | 0 | 89 | 37 | 80 |
| EG002 | Standard Dose Time Period 2 | amoxicillin/clavulnate 875/125 plus placebo bid x 7 days | 0 | 69 | 0 | 69 | 19 | 62 |
| EG003 | High Dose Time Period 2 | immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875 | 0 | 67 | 0 | 67 | 27 | 57 |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment | diarrhea at day 3 |
|
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| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002969 | Clavulanic Acids |
| Title |
|---|
| Measurements |
|---|
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| Streptococcus pneumoniae |
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| Moxarella catarrhalis |
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| Staphylococcus epidermidis |
|
| Methicillin-resistant Staphylococcus aureus |
|