Sinusitis, Acute
Conditions
Brief summary
Comparative-effectiveness study of the treatment of acute bacterial sinusitis with amoxicillin/clavulanate 875mg/125mg bid for 7 days with or without the addition of immediate-release amoxicillin 875 mg bid x 7 days. .
Detailed description
Double-blind comparative-effectiveness study of the treatment of acute bacterial sinusitis with standard dose of amoxicillin/clavulanate 875mg/125mg bid for 7 days, as recommended by the Infectious Disease Society of America, with or without the addition of immediate-release amoxicillin 875 mg bid x 7 days. The study aims are 1) to confirm, or not, our recent findings of more rapid improvement in overall symptoms with the additional amoxicillin, but also of more frequent diarrhea and vaginal yeast infections and 2) to assess, from the participants' point of view, the balance between improvement and adverse effects.
Interventions
DRUGAmoxicillin 875 mg
Doubling the dose of amoxicillin by adding amoxicillin 875 to each dose of the standard treatment of amoxicillin/clavulanate 875/125
DIETARY_SUPPLEMENTPlacebo (lactase)
Placebo (in place of additional amoxicillin in experimental arm)
Sponsors
Paul Sorum, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Unlabeled bottles of study medications, identified only by participant #, prepared by the pharmacist member of research team. The placebo will be similar in appearance to plain amoxicillin. The pills inside the bottle will be difficult to see until the bottle is opened by the patient.
Intervention model description
1. Ill adult patients coming to a primary care office will be diagnosed by the treating physicians with acute bacterial sinusitis in accordance with the guidelines of the Infectious Disease Society of America. 2. If they do not meet exclusion criteria, they will be offered enrollment in the study. 3. If they agree, they will be provided unlabeled study medication, either amoxicillin/clavulanate 875/125 + placebo pills bid x 7 days (standard dose) or amoxicillin/clavulanate 875/125 + amoxicillin immediate-release 875 (high dose). 4. Outcomes will be assessed, by telephone or over the web (through Qualtrics), at 3 and 10 days after enrollment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults 18 and older who are patients at the Albany Medical Center Internal Medicine and Pediatrics practice (study site). 2. Clinical diagnosis of acute bacterial sinusitis in accordance with the guidelines of the Infectious Disease Society of America (fitting into one of 3 categories: persistent sinus symptoms for 10 days or more; severe sinus symptoms for 3 days or more; or worsening sinus symptoms after initial improvement (double sickening).
Exclusion criteria
1. Previous enrollment in the current study 2. Allergy or intolerance to any penicillin or to amoxicillin/clavulanate 3. Serious hypersensitivity reaction to any beta lactam 4. Elevated risk of amoxicillin-resistant bacteria: a. amoxicillin, penicillin, or other beta-lactam within the past month; b. known to have had methicillin-resistant Staph aureus 5. Chronic or recurrent sinus problems (defined as a) persistent symptoms of sinus congestion, not attributed to nasal allergies, for 8 weeks or more or b) 2 or more episodes of antibiotic-treated sinusitis in past 3 months 6. Need to use high-dose amoxicillin/clavulanate or levofloxacin or to send to emergency department or to hospitalize because of a) signs of severe infection or b) immunocompromise 7. Cognitive impairment, so unable to give reliable symptom ratings (even if a health proxy can give consent) 8. Pregnant women and nursing mothers 9. Drug warnings: a) taking allopurinol; b) current mononucleosis; c) chronic kidney disease stage 4 (estimated glomerular filtration rate \<30); d) hepatic impairment (not including isolated transaminase elevated \< 2 times upper limit of normal); e) history of antibiotic-associated colitis (C. difficile)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Global Rating of Improvement of 5 & 6 at the End of 3 Days of Treatment | At end of 3 days of treatment | Rating on a scale of 1=a lot worse, 2=a little worse, 3=the same, 4=a little better, 5=a lot better, 6=no symptoms, with a higher score indicating greater improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Global Rating of Improvement of 5 or 6 at End of 10 Days Since Enrollment | At end of 10 days since enrollment | Rating of 5 (a lot better) or 6 (no symptoms) on Global Rating of Improvement scale, with range of 1 (a lot worse) to 6 (no symptoms), with a higher score indicating greater improvement |
| Change From Baseline in the Total Score on the Sinonasal Outcome Test-16 (SNOT-16) at the End of 3 Days of Treatment | At end of 3 days of treatment | The change between enrollment and the end of 3 days of treatment in the total score on the Sinonasal Outcome Test-16 (SNOT-16). The total SNOT-16 is the sum of the participant's ratings of 16 symptoms of illness on the scale of 0 (no problem) to 3 (severe problem), with a possible range of 0 to 48, with a higher sum indicating more troubling symptoms. A decrease in total score would indicate an improvement in symptoms. |
| Change From Baseline in the Total Score on the Sinonasal Outcome Test-16 (SNOT-16) at the End of 10 Days Since Enrollment | At end of 10 days since enrollment | The change between enrollment and the end of 10 days since enrollment in the total score on the Sinonasal Outcome Test-16 (SNOT-16). The total SNOT-16 is the sum of the participant's ratings of 16 symptoms of illness on the scale of 0 (no problem) to 3 (severe problem), with a possible range of 0 to 48, with a higher sum indicating more troubling symptoms. A decrease in total score would indicate an improvement in symptoms. |
| Balance of Benefits and Detriments | At end of 10 days since enrollment | Assessment of balance between good effects and bad effects of antibiotic on scale of -3=bad effects much greater than good effects to +3=good effects much greater than bad effects |
| Number of Participants Answering Yes to Willingness to Take the Antibiotic Again in the Future | At end of 10 days since enrollment | Response of yes at the end of 10 days since enrollment to the question whether the participant would take this antibiotic again, with possible answers of yes, no, or uncertain. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Female Participants Reporting Any Vaginal Symptoms at Day 10 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | At 10 days since enrollment | Female participants contacted after 10 days since enrollment were divided into two groups: those who had or had not reported at baseline a proneness to vaginal symptoms. The measure was the number in each group who gave ratings of 1, 2, or 3 on the vaginal symptoms scale, ranging from 0 (none) to 3 (severe), with a higher score indicating more severe symptoms. |
| Number of Participants Reporting Any Diarrhea at Day 3 Among Those Self-identified as Prone or Not Prone to Diarrhea | At the end of 3 days | Among those who indicated at enrollment whether prone to diarrhea or not, the number giving ratings of 1, 2, or 3 on diarrhea scale ranging from 0 (none) to 3 (severe) |
| Number of Female Participants Reporting Severe Vaginal Symptoms at Day 10 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | At 10 days since enrollment | Female participants contacted at 10 days since enrollment were divided into two groups: those who had or had not reported at baseline a proneness to vaginal symptoms. The measure was the number in each group who gave rating of 3 on the vaginal symptoms scale, ranging from 0 (none) to 3 (severe), with a higher score indicating more severe symptoms. |
| Number of Participants Reporting Severe Diarrhea at Day 3 Among Those Self-identified as Prone or Not Prone to Diarrhea | At end of day 3 | Among those reporting proneness to diarrhea or not at enrollment, the number rating 3 on diarrhea scale ranging from 0 (none) to 3 (severe) |
| Number of Participants Reporting Any Diarrhea at Day 10 Among Those Self-identified as Prone or Not Prone to Diarrhea | At 10 days since enrollment | Among those indicating at enrollment a proneness or not to diarrhea, the number giving ratings of 1, 2, or 3 on the diarrhea scale ranging from 0 (none) to 3 (severe) |
| Number of Participants Reporting Severe Diarrhea at Day 10 Among Those Self-identified as Prone or Not Prone to Diarrhea | At 10 days since enrollment | Among those indicating proneness to diarrhea or not at enrollment, the number who gave a rating of 3 on the diarrhea scale ranging from 0 (none) to 3 (severe) |
| Number of Female Participants Reporting Any Vaginal Symptoms at Day 3 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | After 3 days of treatment | Female participants contacted after 3 days of treatment were divided into two groups: those who had or had not reported at baseline a proneness to vaginal symptoms. The measure was the number in each group who gave ratings of 1, 2, or 3 on the vaginal symptoms scale, ranging from 0 (none) to 3 (severe), with a higher score indicating more severe symptoms. |
| Number of Female Participants Reporting Severe Vaginal Symptoms at Day 3 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | At the end of 3 days of treatment | Among female participants indicating a proneness or not to vaginal itching or discharge, the number of ratings of 3 on the vaginal symptom scale ranging from 0 (none) to 3 (severe)Female participants contacted after 3 days of treatment were divided into two groups: those who had or had not reported at baseline a proneness to vaginal symptoms. The measure was the number in each group who gave a rating of 1, 3 on the vaginal symptoms scale, ranging from 0 (none) to 3 (severe), with a higher score indicating more severe symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High Dose Amoxicillin 875 mg/clavulanate 125 mg + amoxicillin 875 mg twice a day x 7 days | 78 |
| Standard Dose Amoxicillin 875 mg/clavulanate 125 mg + placebo | 79 |
| Total | 157 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 21 | 19 |
| Overall Study | Withdrawal by Subject | 8 | 3 |
Baseline characteristics
| Characteristic | High Dose | Standard Dose | Total |
|---|---|---|---|
| Age, Continuous | 48.5 years STANDARD_DEVIATION 15.8 | 48.5 years STANDARD_DEVIATION 16.2 | 48.5 years STANDARD_DEVIATION 16 |
| Allergic rhinitis | 10 Participants | 21 Participants | 31 Participants |
| Antibiotics in past month | 1 Participants | 3 Participants | 4 Participants |
| Asthma or COPD | 13 Participants | 7 Participants | 20 Participants |
| Days of illness prior to enrollment | 13.9 days STANDARD_DEVIATION 6 | 17.1 days STANDARD_DEVIATION 11 | 15.4 days STANDARD_DEVIATION 8.9 |
| Diabetes | 4 Participants | 6 Participants | 10 Participants |
| Enrolled in previous study | 10 Participants | 7 Participants | 17 Participants |
| Heart disease | 3 Participants | 3 Participants | 6 Participants |
| History of sinusitis | 19 Participants | 22 Participants | 41 Participants |
| Hospitalized in past month | 0 Participants | 0 Participants | 0 Participants |
| Prone to diarrhea | 11 Participants | 16 Participants | 27 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 57 Participants | 60 Participants | 117 Participants |
| Sex: Female, Male Male | 21 Participants | 19 Participants | 40 Participants |
| Sinonasal Outcome Test-16 total score | 29.4 units on a scale STANDARD_DEVIATION 7.4 | 29.4 units on a scale STANDARD_DEVIATION 8 | 29.4 units on a scale STANDARD_DEVIATION 7.7 |
| Sinusitis category 1 (duration 10 days or greater) | 54 Participants | 58 Participants | 112 Participants |
| Sinusitis category 2 (severe symptoms) | 5 Participants | 6 Participants | 11 Participants |
| Sinusitis category 3 (double sickening) | 18 Participants | 12 Participants | 30 Participants |
| Smoking (No. [%] | 12 Participants | 7 Participants | 19 Participants |
| Tend to be constipated | 15 Participants | 19 Participants | 34 Participants |
| Tend to get vaginal yeast infections | 15 Participants | 15 Participants | 30 Participants |
| Using nasal steroids | 18 Participants | 19 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 79 |
| other Total, other adverse events | 53 / 78 | 52 / 79 |
| serious Total, serious adverse events | 0 / 78 | 0 / 79 |
Outcome results
Primary
Number of Participants With a Global Rating of Improvement of 5 & 6 at the End of 3 Days of Treatment
Rating on a scale of 1=a lot worse, 2=a little worse, 3=the same, 4=a little better, 5=a lot better, 6=no symptoms, with a higher score indicating greater improvement.
Time frame: At end of 3 days of treatment
Population: Participants who provided a Global Rating of Improvement when contacted at the end of 3 days of treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose | Number of Participants With a Global Rating of Improvement of 5 & 6 at the End of 3 Days of Treatment | 24 Participants |
| Standard Dose | Number of Participants With a Global Rating of Improvement of 5 & 6 at the End of 3 Days of Treatment | 31 Participants |
Secondary
Balance of Benefits and Detriments
Assessment of balance between good effects and bad effects of antibiotic on scale of -3=bad effects much greater than good effects to +3=good effects much greater than bad effects
Time frame: At end of 10 days since enrollment
Population: Participants who could be reached to assess their treatment at 10 days since enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose | Balance of Benefits and Detriments | 1.8 score on a scale | Standard Deviation 1.8 |
| Standard Dose | Balance of Benefits and Detriments | 2.2 score on a scale | Standard Deviation 1.5 |
Secondary
Change From Baseline in the Total Score on the Sinonasal Outcome Test-16 (SNOT-16) at the End of 10 Days Since Enrollment
The change between enrollment and the end of 10 days since enrollment in the total score on the Sinonasal Outcome Test-16 (SNOT-16). The total SNOT-16 is the sum of the participant's ratings of 16 symptoms of illness on the scale of 0 (no problem) to 3 (severe problem), with a possible range of 0 to 48, with a higher sum indicating more troubling symptoms. A decrease in total score would indicate an improvement in symptoms.
Time frame: At end of 10 days since enrollment
Population: Participants who could be reached at 10 days since enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose | Change From Baseline in the Total Score on the Sinonasal Outcome Test-16 (SNOT-16) at the End of 10 Days Since Enrollment | 18.4 score on a scale | Standard Deviation 11.4 |
| Standard Dose | Change From Baseline in the Total Score on the Sinonasal Outcome Test-16 (SNOT-16) at the End of 10 Days Since Enrollment | 21.4 score on a scale | Standard Deviation 10.2 |
Secondary
Change From Baseline in the Total Score on the Sinonasal Outcome Test-16 (SNOT-16) at the End of 3 Days of Treatment
The change between enrollment and the end of 3 days of treatment in the total score on the Sinonasal Outcome Test-16 (SNOT-16). The total SNOT-16 is the sum of the participant's ratings of 16 symptoms of illness on the scale of 0 (no problem) to 3 (severe problem), with a possible range of 0 to 48, with a higher sum indicating more troubling symptoms. A decrease in total score would indicate an improvement in symptoms.
Time frame: At end of 3 days of treatment
Population: Participants who provided a SNOT-16 rating when reached at the end of 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose | Change From Baseline in the Total Score on the Sinonasal Outcome Test-16 (SNOT-16) at the End of 3 Days of Treatment | 13.3 score on a scale | Standard Deviation 8.8 |
| Standard Dose | Change From Baseline in the Total Score on the Sinonasal Outcome Test-16 (SNOT-16) at the End of 3 Days of Treatment | 12.3 score on a scale | Standard Deviation 11.5 |
Secondary
Number of Participants Answering Yes to Willingness to Take the Antibiotic Again in the Future
Response of yes at the end of 10 days since enrollment to the question whether the participant would take this antibiotic again, with possible answers of yes, no, or uncertain.
Time frame: At end of 10 days since enrollment
Population: Participants who could be reached at day 10 to assess their treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose | Number of Participants Answering Yes to Willingness to Take the Antibiotic Again in the Future | 34 Participants |
| Standard Dose | Number of Participants Answering Yes to Willingness to Take the Antibiotic Again in the Future | 47 Participants |
Secondary
Number of Participants With a Global Rating of Improvement of 5 or 6 at End of 10 Days Since Enrollment
Rating of 5 (a lot better) or 6 (no symptoms) on Global Rating of Improvement scale, with range of 1 (a lot worse) to 6 (no symptoms), with a higher score indicating greater improvement
Time frame: At end of 10 days since enrollment
Population: Participants who could be reached to give a global rating at the end of 10 days since enrollment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose | Number of Participants With a Global Rating of Improvement of 5 or 6 at End of 10 Days Since Enrollment | 35 Participants |
| Standard Dose | Number of Participants With a Global Rating of Improvement of 5 or 6 at End of 10 Days Since Enrollment | 47 Participants |
Other Pre-specified
Number of Female Participants Reporting Any Vaginal Symptoms at Day 10 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge
Female participants contacted after 10 days since enrollment were divided into two groups: those who had or had not reported at baseline a proneness to vaginal symptoms. The measure was the number in each group who gave ratings of 1, 2, or 3 on the vaginal symptoms scale, ranging from 0 (none) to 3 (severe), with a higher score indicating more severe symptoms.
Time frame: At 10 days since enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose | Number of Female Participants Reporting Any Vaginal Symptoms at Day 10 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | 10 Participants |
| Standard Dose | Number of Female Participants Reporting Any Vaginal Symptoms at Day 10 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | 9 Participants |
Other Pre-specified
Number of Female Participants Reporting Any Vaginal Symptoms at Day 3 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge
Female participants contacted after 3 days of treatment were divided into two groups: those who had or had not reported at baseline a proneness to vaginal symptoms. The measure was the number in each group who gave ratings of 1, 2, or 3 on the vaginal symptoms scale, ranging from 0 (none) to 3 (severe), with a higher score indicating more severe symptoms.
Time frame: After 3 days of treatment
Population: Female participants available at the end of 3 days of treatment who had indicated proneness or not to vaginal symptoms at enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose | Number of Female Participants Reporting Any Vaginal Symptoms at Day 3 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | 6 Participants |
| Standard Dose | Number of Female Participants Reporting Any Vaginal Symptoms at Day 3 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | 11 Participants |
Other Pre-specified
Number of Female Participants Reporting Severe Vaginal Symptoms at Day 10 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge
Female participants contacted at 10 days since enrollment were divided into two groups: those who had or had not reported at baseline a proneness to vaginal symptoms. The measure was the number in each group who gave rating of 3 on the vaginal symptoms scale, ranging from 0 (none) to 3 (severe), with a higher score indicating more severe symptoms.
Time frame: At 10 days since enrollment
Population: Female participants giving ratings of adverse effects at day 10
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose | Number of Female Participants Reporting Severe Vaginal Symptoms at Day 10 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | 0 Participants |
| Standard Dose | Number of Female Participants Reporting Severe Vaginal Symptoms at Day 10 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | 1 Participants |
Other Pre-specified
Number of Female Participants Reporting Severe Vaginal Symptoms at Day 3 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge
Among female participants indicating a proneness or not to vaginal itching or discharge, the number of ratings of 3 on the vaginal symptom scale ranging from 0 (none) to 3 (severe)Female participants contacted after 3 days of treatment were divided into two groups: those who had or had not reported at baseline a proneness to vaginal symptoms. The measure was the number in each group who gave a rating of 1, 3 on the vaginal symptoms scale, ranging from 0 (none) to 3 (severe), with a higher score indicating more severe symptoms.
Time frame: At the end of 3 days of treatment
Population: Female participants reporting adverse effects at day 3
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose | Number of Female Participants Reporting Severe Vaginal Symptoms at Day 3 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | 0 Participants |
| Standard Dose | Number of Female Participants Reporting Severe Vaginal Symptoms at Day 3 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | 2 Participants |
Other Pre-specified
Number of Participants Reporting Any Diarrhea at Day 10 Among Those Self-identified as Prone or Not Prone to Diarrhea
Among those indicating at enrollment a proneness or not to diarrhea, the number giving ratings of 1, 2, or 3 on the diarrhea scale ranging from 0 (none) to 3 (severe)
Time frame: At 10 days since enrollment
Population: Participants indicating their adverse effects at 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose | Number of Participants Reporting Any Diarrhea at Day 10 Among Those Self-identified as Prone or Not Prone to Diarrhea | 6 Participants |
| Standard Dose | Number of Participants Reporting Any Diarrhea at Day 10 Among Those Self-identified as Prone or Not Prone to Diarrhea | 21 Participants |
Other Pre-specified
Number of Participants Reporting Any Diarrhea at Day 3 Among Those Self-identified as Prone or Not Prone to Diarrhea
Among those who indicated at enrollment whether prone to diarrhea or not, the number giving ratings of 1, 2, or 3 on diarrhea scale ranging from 0 (none) to 3 (severe)
Time frame: At the end of 3 days
Population: Participants giving a rating of diarrhea at the end of day 3
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose | Number of Participants Reporting Any Diarrhea at Day 3 Among Those Self-identified as Prone or Not Prone to Diarrhea | 16 Participants |
| Standard Dose | Number of Participants Reporting Any Diarrhea at Day 3 Among Those Self-identified as Prone or Not Prone to Diarrhea | 41 Participants |
Other Pre-specified
Number of Participants Reporting Severe Diarrhea at Day 10 Among Those Self-identified as Prone or Not Prone to Diarrhea
Among those indicating proneness to diarrhea or not at enrollment, the number who gave a rating of 3 on the diarrhea scale ranging from 0 (none) to 3 (severe)
Time frame: At 10 days since enrollment
Population: Participants who gave ratings of adverse effects at day 10
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose | Number of Participants Reporting Severe Diarrhea at Day 10 Among Those Self-identified as Prone or Not Prone to Diarrhea | 1 Participants |
| Standard Dose | Number of Participants Reporting Severe Diarrhea at Day 10 Among Those Self-identified as Prone or Not Prone to Diarrhea | 4 Participants |
Other Pre-specified
Number of Participants Reporting Severe Diarrhea at Day 3 Among Those Self-identified as Prone or Not Prone to Diarrhea
Among those reporting proneness to diarrhea or not at enrollment, the number rating 3 on diarrhea scale ranging from 0 (none) to 3 (severe)
Time frame: At end of day 3
Population: Participants who indicated whether prone to diarrhea or not at enrollment and then at follow-up rated their diarrhea
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose | Number of Participants Reporting Severe Diarrhea at Day 3 Among Those Self-identified as Prone or Not Prone to Diarrhea | 4 Participants |
| Standard Dose | Number of Participants Reporting Severe Diarrhea at Day 3 Among Those Self-identified as Prone or Not Prone to Diarrhea | 6 Participants |