Clinical trials: Group A Streptococcus
- Condition Group A Streptococcus
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Group A Streptococcus
Strep A FIA Field Study, Sofia
To demonstrate the clinical performance of the Strep A FIA and Sofia, using throat swabs collected from symptomatic subjects.
- Trial name
- NCT02153008
- Where
- 7 sites in United States
- Volunteers
- 1,708 people
- Sponsor
- Quidel Corporation
Pharyngitis
APC-231 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) in Pediatric Patients With Strep Throat
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.
- Trial name
- NCT00100126
- Testing
- Amoxicillin Pulsatile Release Multiparticluate Sprinkle
- Where
- 2 sites in United States
- Volunteers
- 500 people
- Sponsor
- Advancis Pharmaceutical Corporation
Streptococcus Pyogenes Infection, Pharyngitis
Clinical Performance of the Checkable Medical At-Home Strep A Test
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.
- Conditions
- Streptococcus Pyogenes Infection, Pharyngitis, Respiratory Tract Infections
- Trial name
- NCT05107362
- Testing
- untrained lay user performs investigational diagnostic test
- Where
- 22 sites in United States
- Volunteers
- 1,347 people
- Sponsor
- Checkable Medical Inc
Tonsillitis
Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children
The primary objective of this study is to demonstrate the non-inferiority, at the assessment visit (V3 (D10/D14)), in terms of bacteriological efficacy of pristinamycin (PRI) administered for 4 days versus amoxicillin (AMX)…
- Trial name
- PRI-angine (NCT00393744)
- Testing
- pristinamycin, amoxicillin
- Where
- France
- Volunteers
- 395 people
- Sponsor
- Sanofi
Group A Streptococcus, Strep Throat
Sofia Strep A FIA Field Study
The purpose of this study is to demonstrate the ability of the Sofia Strep A FIA test and Sofia Analyzer to accurately detect a throat swab specimen for the presence or absence of Group A Streptococcus when compared to culture.
- Trial name
- NCT01494792
- Testing
- In Vitro Diagnositc aid for diagnosis
- Where
- 8 sites in United States
- Volunteers
- 2,090 people
- Sponsor
- Quidel Corporation
Group B Streptococcus Infections
Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants
Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety, tolerability and immunogenicity of the investigational multivalent group B streptococcus vaccine administered at one dose level (various…
- Trial name
- NCT03765073
- Testing
- Multivalent Group B streptococcus vaccine
- Where
- 35 sites in United States, South Africa and 1 more
- Volunteers
- 1,208 people, healthy volunteers welcome
- Sponsor
- Pfizer
Tonsillitis, Pharyngitis
TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults
This is a multinational, randomized (1:1), double blind, comparator-controlled, 2 parallel treatment group study in subjects equal to or over 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P).
- Trial name
- NCT00315549
- Testing
- Telithromycin, Penicillin
- Where
- 4 sites in United States, Argentina and 2 more
- Volunteers
- 233 people
- Sponsor
- Sanofi
Streptococcal Pharyngitis, Group A Streptococcal Infection
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
The goal of this observational study is to learn how well the SalivIQ™ Strep A test detects Group A Streptococcus, the bacteria that cause strep throat.
- Trial name
- NCT07891728
- Testing
- qPCR
- Where
- 3 sites in United States
- Volunteers
- 668 people
- Sponsor
- SalivIQ Diagnostics, Inc.
Tonsillitis, Pharyngitis
TELI TON - Telithromycin in Tonsillitis
This is a multinational, randomized (1:1), double blind, double dummy, comparator-controlled, 2 parallel treatment group study in subjects from 6 months to < 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis…
- Trial name
- NCT00315042
- Testing
- Telithromycin (HMR3647), Penicillin
- Where
- 5 sites in United States, Argentina and 3 more
- Volunteers
- 314 people
- Sponsor
- Sanofi
Group A Streptococcal Infection
Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis
Participants who meet the eligibility criteria and who consent to participation or whose parents/legal guardian consent to their participation, will be enrolled in the study for a period of up to 14 days.
- Trial name
- NCT03693495
- Testing
- ellume·lab Group A Streptococcus Test, Bacterial Culture, Polymerase Chain Reaction (PCR)
- Where
- 4 sites in New Zealand
- Sponsor
- Ellume Pty Ltd
Group A Streptococcal Infection
Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Patients With Acute Pharyngitis.
Participants who meet the eligibility criteria and who consent to participation or whose parents/legal guardian consent to their participation, will be enrolled in the study for a period of up to 14 days.
- Trial name
- NCT03171350
- Testing
- ellume.lab Group A Streptococcus Test
- Where
- 8 sites in Australia
- Volunteers
- 132 people
- Sponsor
- Ellume Pty Ltd
Pregnancy, GBS
Clinical Evaluation of the ARIES Group B Streptococcus (GBS) Assay
The ARIES GBS Assay is a real-time PCR based qualitative test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women between 35 - 37 weeks…
- Trial name
- NCT02497430
- Where
- 5 sites in United States
- Volunteers
- 918 people, healthy volunteers welcome
- Sponsor
- Luminex Corporation
Healthy
BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies.
- Trial name
- NCT07160244
- Testing
- Multivalent Group B streptococcus vaccine, Infanrix hexa, Prevenar 20
- Where
- 219 sites in United States, Argentina and 13 more
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Pfizer
Strep Throat
Evaluation of the IND One Step Strep A Rapid Test vs. Culture
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…
- Trial name
- NCT01491776
- Where
- 3 sites in United States
- Volunteers
- 315 people
- Sponsor
- IND Diagnostic Inc.
Pharyngitis, Infective
Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.
The primary purpose of this clinical investigation is to establish the performance of the GenePOC Strep A, C/G assay on the revogene.
- Trial name
- NCT03422341
- Testing
- Comparison between GenePOC CR and Reference Method
- Where
- 8 sites in United States, Canada
- Volunteers
- 497 people
- Sponsor
- Meridian Bioscience, Inc.
Pharyngitis, Tonsillitis
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
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.
- Trial name
- NCT00095368
- Testing
- Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Advancis Pharmaceutical Corporation