Pharyngitis Clinical Trial
— TOPSOfficial title:
Treatment of Pharyngitis Study (TOPS): A Randomized Equivalence Trial of Intramuscular Penicillin G vs. Oral Amoxicillin Antibiotics for the Treatment of Streptococcal Pharyngitis in Children in Developing Countries
The purpose of this study was to compare the microbiological effects of two different treatments: a single dose of intramuscular benzathine penicillin G (IM BPG) vs. a 10-day daily dose of amoxicillin for the treatment of GABHS pharyngitis in children in low resource settings. This study was a prospective multi-center randomized active control treatment trial. The trial is a non-inferiority equivalence trial, to determine if amoxicillin treatment is at least as effective as the currently given IM BPG treatment.
Status | Completed |
Enrollment | 558 |
Est. completion date | April 2003 |
Est. primary completion date | April 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 12 Years |
Eligibility |
Inclusion Criteria: - Age: 2-12 years old, - Presenting with complaint of sore throat - Parental consent given and child assent if 5 years or older Exclusion Criteria: - The parent/guardian reported oral antibiotic use in the past 3 days or injectable penicillin in past 28 days prior to screening - Had a history of rheumatic fever or rheumatic heart disease - Required hospitalization for any reason at the time of enrollment - Had previously been enrolled in the study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of Rio de Janeiro | Rio de Janeiro | |
Croatia | University Hospital for Infectious Diseases | Zagreb | |
Egypt | Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Cairo University, United States Agency for International Development (USAID), Universidade Federal do Rio de Janeiro, University Hospital for Infectious Diseases, Croatia, World Health Organization |
Brazil, Croatia, Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Eradication of Group A Streptococcus (GAS) | The primary outcome of the study was bacteriologic treatment success, which was defined as eradication of GAS from the pharynx at the follow up visit. Eradication was defined as no GAS present on the throat culture. | 21-28 days after 1st visit | Yes |
Secondary | Compliance to treatment | Compliance with the amoxicillin treatment regimen was assessed at the follow up visit. The primary measure of compliance was the presence of antimicrobial activity in the urine-impregnated filter paper strips. For those who did not return the filter paper strip, compliance was measured by parent/guardian report during the exit interview. Patients who did not fulfill at least one of these criteria were considered noncompliant. | 21-28 days after 1st visit | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01453400 -
Evaluate the Time of Pain Relief of Fast Acting Aspirin Versus Acetaminophen in Subjects Diagnosed With Sore Throat Pain
|
Phase 3 | |
Completed |
NCT04016051 -
Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections
|
Phase 3 | |
Recruiting |
NCT01681667 -
Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain
|
Phase 4 | |
Completed |
NCT00527852 -
Assessment of Flocked Swabs for the Identification of Group A Streptococcal Pharyngitis
|
N/A | |
Completed |
NCT02178293 -
Ketoprofen Lysine Salt as Mouthwash in Acute Phlogosis of the Pharyngeal Cavity Versus Benzidamine Hydrochloride
|
Phase 4 | |
Active, not recruiting |
NCT05127161 -
Broad Implementation of Outpatient Stewardship
|
N/A | |
Withdrawn |
NCT02535962 -
Probiotics and Corticosteroids for Treating Periodic Fever, Aphthous Stomatitis, Pharyngitis, Cervical Adenitis (PFAPA)
|
Phase 2 | |
Not yet recruiting |
NCT02252419 -
Combined Effect of Dexamethasone and Paracetamol for Postoperative Sore Throat
|
N/A | |
Completed |
NCT00798018 -
Effect of Intra-cuff Lidocaine and Tetracaine on Tracheal Tube-induced Emergence Phenomena
|
N/A | |
Completed |
NCT00535093 -
An Assessment of Rapid Streptococcal Tests in Community Clinics in Israel
|
N/A | |
Completed |
NCT00148499 -
Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat. With Acute/Viralpharyngitis
|
Phase 3 | |
Completed |
NCT00095368 -
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
|
Phase 3 | |
Recruiting |
NCT06027593 -
Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions
|
N/A | |
Recruiting |
NCT03720301 -
The Use of Osteopathic Medical Manipulation to Decrease the Incidence and Severity of Post-Operative Sore Throat
|
N/A | |
Completed |
NCT01361399 -
Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold
|
Phase 3 | |
Completed |
NCT01398696 -
Impact of Four Patient Information Leaflets (PIL) on Patient Behaviour
|
Phase 4 | |
Completed |
NCT01049334 -
A Study of Flurbiprofen 8.75 mg Lozenge in Patient With Pharyngitis
|
Phase 3 | |
Completed |
NCT01048866 -
A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis
|
Phase 3 | |
Completed |
NCT00547391 -
Recurrent Throat Infections and Tonsillectomy
|
Phase 4 | |
Completed |
NCT00242281 -
APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat
|
Phase 3 |