Treatment Trials

20 Clinical Trials for Various Conditions

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TERMINATED
Treatment of Acute Sinusitis With High-Dose vs. Standard-Dose Amoxicillin/Clavulanate
Description

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. .

COMPLETED
Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
Description

The objective of this trial is to determine whether certain subgroups of children with acute sinusitis exist in whom antibiotic therapy can be appropriately withheld.

COMPLETED
Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate
Description

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.

Conditions
COMPLETED
Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients (CABERNET)
Description

This post-market study aims to compare health outcomes for Recurrent Acute Rhinosinusitis (RARS) patients treated with balloon sinus dilation (BSD) versus medical management alone.

COMPLETED
Pilot Study to Determine Efficacy of Cyclamen Europaeum Extract Nasal Spray in Patients With Acute Sinusitis
Description

To evaluate the efficacy and safety of Cyclamen europaeum extract 10 % (v/v) compared to placebo in subjects with acute sinusitis

Conditions
COMPLETED
Treatment of Acute Sinusitis
Description

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.

TERMINATED
Study to Measure the Impact of Antibiotics on Bacterial Flora in Adults With Acute Sinusitis
Description

The purpose of this study is to measure the speed of microbial eradication due to azithromycin or telithromycin in acute maxillary sinusitis (AMS).

COMPLETED
Comparison Study Between Cefdinir & Amoxicilline/Clavulanate in Acute Sinusitis and Assessment of Quality of Life
Description

This study is a comparison between two commonly used antibiotics (Cefdinir vs. Amoxicillin/Clavulanate) in patients with acute sinus infection, surveying quality of life. The hypothesis is that the two treatments would be at the least equivalent based on clinical outcome measures of improvement in quality of life.

COMPLETED
Guidelines for Acute Sinusitis
Description

Viral upper respiratory infections occur frequently during childhood (6-8 per year) and are, for the most part, self-limited episodes that resolve spontaneously and do not require antibiotic therapy. Acute otitis media and acute bacterial sinusitis are frequent complications of viral upper respiratory infections that will benefit from treatment with antibiotics. Acute bacterial sinusitis is one of the most common diagnoses in ambulatory practice and, in all age groups, accounts for an estimated 25 million physician office visits annually. It is essential to distinguish between patients who are experiencing uncomplicated viral upper respiratory infections and acute bacterial sinusitis to avoid the excessive use of antibiotics for patients who will not benefit from them. This is especially important now because of the escalation of antibiotic resistance among the bacteria that commonly cause acute bacterial sinusitis, acute otitis media and pneumonia. Inappropriate use of antibiotics is a major contributor to the problem of antimicrobial resistance - a problem which dramatically increases both the cost and complexity of treatment. To improve the diagnosis and treatment of patients with acute bacterial sinusitis and reduce the inappropriate use of antibiotics, clinical guidelines have been developed by three national organizations: the American Academy of Pediatrics, the Sinus and Allergy Health Partnership and the Centers for Disease Control and Prevention. Traditionally, the diagnosis of acute bacterial sinusitis is suspected on the basis of clinical signs and symptoms and is confirmed with the performance of images (either plain radiographs, computed tomography or magnetic resonance imaging). All three guidelines recommend that the diagnosis and treatment of acute bacterial sinusitis should be based on clinical criteria alone without the confirmation of imaging or other laboratory data. Although the similarity between the different guidelines suggests that there is widespread consensus to use clinical criteria to diagnose acute bacterial sinusitis, there is virtually no evidence to support this position. Specific Aim 1 of this project is to evaluate the use of clinical criteria, without the performance of images, as the basis for the diagnosis of acute bacterial sinusitis. A randomized, placebo-controlled study design will be used to determine if the clinical criteria proposed by the different guidelines can be used to identify children with upper respiratory symptoms who will respond to antibiotic therapy. It is expected that children with acute bacterial sinusitis who receive an antimicrobial will recover more quickly and more often than children who receive placebo.

Conditions
COMPLETED
Antimicrobial Stewardship for Primary Care Pediatricians
Description

The purpose of the study is to determine if physician education coupled with audit and feedback of antibiotic prescribing can improve antibiotic prescribing by primary care clinicians.

ACTIVE_NOT_RECRUITING
Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis
Description

Sinus infections are sometimes treated with oral antibiotics or nasal steroid sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. Sometimes this is enough to help patients wait a few days to see if their infection clears up without needing to use antibiotics or nasal steroid sprays. The overall goal of this clinical trial to see which specific groups of patients benefit more from which intervention or combination of intervention, and which improve with supportive care alone.

ACTIVE_NOT_RECRUITING
Broad Implementation of Outpatient Stewardship
Description

Reducing inappropriate antibiotic use is a key strategy to mitigate antibiotic resistance and adverse health effects associated with antibiotic exposure. The Broad Implementation of Outpatient Stewardship (BIOS) project focuses on broadly implementing an evidence-based intervention to improve antibiotic prescribing for acute respiratory tract infections in pediatric outpatient settings. Primary aims include: (1) examining the acceptability, feasibility and utility of a focused implementation strategy on improving intervention adoption and impact and (2) measuring the effectiveness of the intervention to reduce unnecessary broad-spectrum antibiotic prescription.

COMPLETED
Comparative Effectiveness of Antibiotics for Respiratory Infections
Description

The purpose of this study is to identify and use patient centered outcomes to compare narrow-spectrum and broad-spectrum antibiotics for the treatment of common acute respiratory tract infections (ARTIs) in children.

COMPLETED
Gulf War Illness Nasal Irrigation Study
Description

The purpose of this study is to determine whether nasal irrigation with Xylitol or saline are effective in the treatment of chronic rhinosinusitis and fatigue symptoms associated with Gulf War Illness.

TERMINATED
Point-of-Care Immunoassay for Detection of Bacterial Sinusitis
Description

This study is conducted to evaluate the performance of a rapid, point-of-care in vitro diagnostic device (Sinu-Test®) for the qualitative detection of the three most common pathogens responsible for causing bacterial sinusitis.

COMPLETED
Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
Description

The investigators objective is to compare short course (5 days) to long course (14 days)antibiotics for the treatment of acute bacterial sinusitis in children. The investigators hypothesize that short course therapy will lead to more frequent relapses of sinusitis and will not reduce resistant organisms.

Conditions
COMPLETED
Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis
Description

To compare the safety and efficacy of a ten-day course of therapy of cefdinir, 600 mg QD, to a ten-day course of therapy of levofloxacin, 500 mg QD, in the treatment of acute bacterial sinusitis.

COMPLETED
Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis
Description

To compare the safety/tolerability and efficacy of a 14-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 14-day course of amoxicillin-clavulanate tablets (875/125 mg BID) for the treatment of ambulatory subjects with Acute Bacterial Sinusitis (ABS).

COMPLETED
A Trial of Point of Care Information in Ambulatory Pediatrics
Description

Does presentation of clinical evidence for decision making at point-of-care improve prescribing patterns in ambulatory pediatrics?

COMPLETED
Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients
Description

Clinical research study to test amoxicillin and clavulanate tablet formulation for use in Acute Bacterial Sinusitis (ABS) in adolescent patients weighing at least 40 kilogram (kg) and no more than 16 years old. ABS is an acute bacterial infection of the sinus. The purpose of this study is to find out how children tolerate Augmentin XR and what happens to Augmentin XR in the body after it has been swallowed by children.