Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00377403
Status:
COMPLETED
Last Update Posted:
2012-12-28
First Post:
2006-09-14
Brief Title:
Treatment of Acute Sinusitis
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Randomized Clinical Trial to Evaluate Guidelines for Acute Rhinosinusitis Phase IV Study
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will compare the symptom relief provided by 5 cold medicines versus the symptom relief provided by the same 5 cold medicines plus the antibiotic amoxicillin in people who have sinus infections Treatment with amoxicillin may be more effective than treatment with cold medicines alone Two hundred adult volunteers aged 18 to 70 years old with sinus infections will participate in this study for 28 days Volunteers will receive a 10-day course of either amoxicillin or placebo substance containing no medication In addition all volunteers will receive pain medication a chest decongestant nasal decongestants and cough medicine as needed Volunteers will be interviewed by telephone on days 0 3 7 10 and 28 following the start of treatment The study will look at quality of life factors such as change in functional status ability to perform daily activities and symptoms recurrence of the infection satisfaction with care and the direct costs of treatment
Detailed Description:
The primary objective of this phase IV randomized placebo controlled clinical trial is to determine the incremental effect of amoxicillin treatment compared with symptomatic treatments on disease-related quality of life in adults with clinically diagnosed acute bacterial rhinosinusitis The secondary objective is to determine the incremental effect of amoxicillin treatment compared with symptomatic treatments on functional status symptoms disease recurrence satisfaction with treatment and direct costs of treatment in adults with clinically diagnosed acute bacterial rhinosinusitis The tertiary objective is to identify prognostic indicators for clinical improvement with antibiotic treatment in adults with clinically diagnosed acute bacterial rhinosinusitis Two hundred adult subjects 18 to 70 years old who meet the recommended criteria for acute bacterial rhinosinusitis will be enrolled from 8 practice sites Subjects will be randomized to receive a 10-day course of either amoxicillin or placebo In addition all subjects will receive an analgesic an oral decongestant a nasal saline spray and an antitussive agent Subject outcomes will be assessed by telephone interview at 0 3 7 10 and 28 days The primary outcome is the disease-specific quality of life at Day 3 measured with the SNOT-16 a validated evaluative instrument Secondary outcomes include change in functional status and symptoms disease recurrence satisfaction with care and the direct costs of treatment Tertiary outcome measures include possible subject and disease-related factors that predict clinical improvement with antibiotic treatment at Day 3 for use in future studies to aid clinical decision-making
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01AI064655-01A1 | NIH | None | httpsreporternihgovquickSearchU01AI064655-01A1 |