Health TrialsbyHealthPanel

Short Versus Standard Amoxicillin for Pediatric Strep Throat

ConditionGroup A Streptococcal (GAS) Pharyngitis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-18
SponsorThe University of Texas Health Science Center, Houston

About this trial

The purpose of this study is to compare 5-day vs 10-day amoxicillin for strep throat in children.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

confirmed Group A streptococcal (GAS) pharyngitis, defined by a positive rapid antigen detection test

Receiving care at either the University of Texas Pediatrics General Clinic or the Memorial Hermann Emergency Department

Written informed consent obtained from a parent or legal guardian, with assent from the child when developmentally appropriate and required by institutional policy.

Disqualifiers

Known allergy or hypersensitivity to penicillin, amoxicillin, or other beta-lactam antibiotics

Severe or complicated illness requiring hospitalization at presentation.

History of acute rheumatic fever, post-streptococcal glomerulonephritis, or other conditions for which prolonged antibiotic therapy is specifically indicated.

Immunocompromised state, including but not limited to: Active malignancy receiving chemotherapy, Solid-organ or hematopoietic stem cell transplant, Chronic systemic immunosuppressive therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 5 day short course antibiotic treatment

    Drug

    Participants will receive oral penicillin or amoxicillin for 5 days

  • 10 day standard of care antibiotic treatment

    Drug

    Participants will receive oral penicillin or amoxicillin for 10 days

Treatment groups

1,500 Participants
are divided into 2 treatment groups
Group A: 5 day short course antibiotic treatmentExperimental treatment 1 intervention
Group B: 10 day standard of care antibiotic treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants that demonstrate resolution of throat pain and fever as reported by the participant/caregiver

Time frame
about 14 days after treatment initiation
2

Number of participants that do not require additional or alternative antibiotic therapy for Group A Streptococcal (GAS) pharyngitis

Time frame
about 14 days after treatment initiation

Secondary outcomes

1

Number of participants that demonstrate improvement in pain

Time frame
From baseline to day 14
2

Number of participants that demonstrate improvement in fever

Time frame
From baseline to day 14
3

Number of participants that demonstrate improvement in treatment tolerance

Time frame
From baseline to day 14
4

Number of participants that complete the prescribed antibiotic course, assessed by caregiver report

Time frame
Day 14

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: