Treatment Trials

12 Clinical Trials for Various Conditions

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COMPLETED
Evidence Based Decision Making: Integrating Clinical Prediction Rules
Description

Clinical prediction rules (CPRs) are frontline decision aids that help physicians make evidence-based, cost-effective decisions that benefit their patients. The aims of this project are to incorporate two well validated CPRs (Streptococcal Pharyngitis Prediction Rule and the Pneumonia Clinical Prediction Rule) into an outpatient Electronic Medical Record System (EMR) and to perform a randomized controlled trial of the effectiveness of integrated CPRs impact on doctor's behaviors (e.g. test ordering and medication prescribing).

COMPLETED
Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis
Description

The purpose of this study is to determine if the rapid antigen detection test for Group A streptococcal pharyngitis diagnosis might yield higher rates of false positive results in patients who have been treated for GAS pharyngitis within 28 days of the test.

COMPLETED
Clinical Performance of the Checkable Medical At-Home Strep A Test
Description

The Checkable Medical At-Home Strep A Test is a rapid chromatographic immunoassay for the qualitative detection of Group A Strep (GAS) antigens from throat swabs. The purpose of the study is to evaluate the clinical performance of the investigational device (i.e., sensitivity, specificity, NPV and PPV) when used by untrained lay persons to detect the presence of Group A Streptococcal antigens in throat swab specimens from individuals five years of age and older with signs and symptoms of pharyngitis, such as fever and sore throat.

COMPLETED
Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.
Description

The primary purpose of this clinical investigation is to establish the performance of the GenePOC Strep A, C/G assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Group A β-hemolytic Streptococcus (GAS) and pyogenic Group C and G β-hemolytic Streptococcus (GCS/GGS) in throat swab samples.

COMPLETED
A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients
Description

A multi-center evaluation to assess the diagnostic sensitivity and specificity of the ARIES Group A Strep Assay will be established through a method comparison using prospectively collected, de-identified, clinical samples collected during the enrollment period.

UNKNOWN
Evaluation of the IND One Step Strep A Rapid Test vs. Culture
Description

The purpose of this study is to demonstrate the ability of the IND One Step Strep A test to accurately test a throat swab specimen from a symptomatic patient for the presence or absence of Group A Streptococcus (Strep A) when compared to culture.

Conditions
COMPLETED
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults
Description

To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and adults with strep throat, and to assess efficacy and safety for both treatment regimens.

COMPLETED
APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat
Description

The primary objective of this study is to evaluate the efficacy of APC 111 MP Tablet, 775 mg tablet, given orally (PO)once daily (QD) for 10 days compared to that of Penicillin VK, 250 mg PO four times daily (QID) for 10 days in terms of bacteriological outcome at the Test-of-Cure (TOC) Visit (Day 14-18) in the eligible Per-Protocol bacteriological (PPb) population.

COMPLETED
APC-231 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) in Pediatric Patients With Strep Throat
Description

The purpose of this study is to evaluate the efficacy and safety of APC-231 QD for 7 days in the bacteriological outcome at the Test of Cure Visit.

Conditions
COMPLETED
APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep Throat
Description

The purpose of the this study is to evaluate the safety of efficacy of APC-111 775 mg MP tablet once daily dosing for 7 days for treating patients with strep throat. The evaluation will look to confirm if APC-111 eliminates the bacterial infection (Streptococcus pyogenes).

COMPLETED
Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal Pharyngitis
Description

The objective of this pilot study is to acquire images using the Strepic® device, a clinical prototype that has been designed specifically as a viable, low-cost, commercially realizable autofluorescence-based diagnostic test, using (1) fluorescence and (2) white light image data, as well as other clinical data points. By acquiring and analyzing the images of pharyngeal bacterial fluorescence and white light patterns in patients with Group A Streptococcus (GAS)-associated pharyngitis and comparing them with those observed in non-GAS pharyngitis, it is believed an algorithm can be developed such that the device will improve the ability of clinicians to quickly and accurately identify GAS infections.

COMPLETED
In Vitro Diagnostic Device for the Detection of Strep A
Description

The purpose of this trial is to show the accuracy and specificity of the Liat analyzer and assay for detecting Strep A at the point of care lab compared to culture.