Group A Streptococcal (GAS) PharyngitisPhase 4NCT07845812
Short Versus Standard Amoxicillin for Pediatric Strep Throat
A Phase 4 study testing 5 day short course antibiotic treatment in people with Group A Streptococcal (GAS) Pharyngitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to compare 5-day vs 10-day amoxicillin for strep throat in children. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Group A Streptococcal (GAS) Pharyngitis
- What is being tested?
- 5 day short course antibiotic treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2026to 28 Sep 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
- Antibiotic use with activity against Group A Streptococcus within the preceding 7 days.
- Inability to take oral medications or anticipated inability to complete outpatient therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Guliz Erdem, MD, 713-500-5806, Guliz.Erdem@uth.tmc.edu
Gabriela Paula Del Bianco, (713) 500-5806, Gabriela.Del.Bianco@uth.tmc.edu
About this study
Official title: Short vs Standard Amoxicillin for Pediatric Strep Throat: A Patient-Centered Pragmatic Trial
The purpose of this study is to compare 5-day vs 10-day amoxicillin for strep throat in children.
- Conditions
- Group A Streptococcal (GAS) Pharyngitis
- Being tested
- 5 day short course antibiotic treatment, 10 day standard of care antibiotic treatment
- Keywords
- antibiotics
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 day short course antibiotic treatmentDrug
Participants will receive oral penicillin or amoxicillin for 5 days
10 day standard of care antibiotic treatmentDrug
Participants will receive oral penicillin or amoxicillin for 10 days
| Study group | Role | What they receive |
|---|---|---|
| 5 day short course antibiotic treatment | Experimental | Not described Receives: Drug: 5 day short course antibiotic treatment |
| 10 day standard of care antibiotic treatment | Active comparator | Not described Receives: Drug: 10 day standard of care antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that demonstrate resolution of throat pain and fever as reported by the participant/caregiver
Measured: about 14 days after treatment initiation
Number of participants that do not require additional or alternative antibiotic therapy for Group A Streptococcal (GAS) pharyngitis
Measured: about 14 days after treatment initiation
Secondary outcomes (9)
Number of participants that demonstrate improvement in pain
Measured: From baseline to day 14
Number of participants that demonstrate improvement in fever
Measured: From baseline to day 14
Number of participants that demonstrate improvement in treatment tolerance
Measured: From baseline to day 14
Number of participants that complete the prescribed antibiotic course, assessed by caregiver report
Measured: Day 14
Number of participants that have Antibiotic-Associated Adverse Effects
Occurrence of non-serious, expected effects (e.g., gastrointestinal symptoms, rash), assessed by caregiver report and chart review
Measured: From baseline to day 14
Number of participants that have recurrence of symptomatic GAS pharyngitis requiring additional medical evaluation or treatment.
Measured: From the end of study treatment through Day 30
Number of participants with an emergency department visit, urgent care visit, or unplanned clinic encounter related to pharyngitis symptoms
Measured: Within 30 days after completion of study treatment
Number of school days missed due to pharyngitis-related illness, as reported by the caregiver.
Measured: Within 14 days after completion of study treatment
Number of caregiver workdays missed due to the child's illness
Measured: Within 14 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start28 Sep 2026 (estimated)
- Primary completion28 Apr 2029 (estimated)
- Study completion28 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group A Streptococcal (GAS) PharyngitisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guliz Erdem, The University of Texas Health Science Center, Houston
- Investigators
- Guliz Erdem, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845812
- Sponsor's protocol ID
- HSC-MS-26-0522
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short vs Standard Amoxicillin for Pediatric Strep Throat: A Patient-Centered Pragmatic Trial
- ClinicalTrials.gov ID
- NCT07845812
- Acronym / sponsor ID
- HSC-MS-26-0522
- Conditions
- Group A Streptococcal (GAS) Pharyngitis
- Keywords
- antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- 28 Apr 2029 (estimated)
- Study completion
- 28 Sep 2029 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare 5-day vs 10-day amoxicillin for strep throat in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 day short course antibiotic treatment | Experimental | Drug: 5 day short course antibiotic treatment |
| 10 day standard of care antibiotic treatment | Active comparator | Drug: 10 day standard of care antibiotic treatment |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
- Antibiotic use with activity against Group A Streptococcus within the preceding 7 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 day short course antibiotic treatmentParticipants will receive oral penicillin or amoxicillin for 5 days | Drug | 5 day short course antibiotic treatment |
| 10 day standard of care antibiotic treatmentParticipants will receive oral penicillin or amoxicillin for 10 days | Drug | 10 day standard of care antibiotic treatment |
Primary outcome
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
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
9 secondary outcomes
Number of participants that demonstrate improvement in pain
Time frame: From baseline to day 14
Number of participants that demonstrate improvement in fever
Time frame: From baseline to day 14
Number of participants that demonstrate improvement in treatment tolerance
Time frame: From baseline to day 14
Number of participants that complete the prescribed antibiotic course, assessed by caregiver report
Time frame: Day 14
Number of participants that have Antibiotic-Associated Adverse Effects
Time frame: From baseline to day 14
Number of participants that have recurrence of symptomatic GAS pharyngitis requiring additional medical evaluation or treatment.
Time frame: From the end of study treatment through Day 30
Number of participants with an emergency department visit, urgent care visit, or unplanned clinic encounter related to pharyngitis symptoms
Time frame: Within 30 days after completion of study treatment
Number of school days missed due to pharyngitis-related illness, as reported by the caregiver.
Time frame: Within 14 days after completion of study treatment
Number of caregiver workdays missed due to the child's illness
Time frame: Within 14 days after completion of study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Group A Streptococcal (GAS) Pharyngitis
RecruitingObservational study
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
Streptococcal Pharyngitis, Group A Streptococcal Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guliz Erdem, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 5 day short course antibiotic treatment in people with Group A Streptococcal (GAS) Pharyngitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guliz Erdem, MD ((713) 500-5806, Guliz.Erdem@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.