NCT07845812

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for phase_4

Timeline
37mo left

Started Sep 2026

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Sep 2026Sep 2029

First Submitted

Initial submission to the registry

September 21, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

September 28, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2029

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2029

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

2.6 years

First QC Date

September 21, 2026

Last Update Submit

September 21, 2026

Conditions

Group A Streptococcal (GAS) Pharyngitis

Keywords

antibiotics

Outcome Measures

Primary Outcomes (2)

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

    about 14 days after treatment initiation

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

    about 14 days after treatment initiation

Secondary Outcomes (9)

  • Number of participants that demonstrate improvement in pain

    From baseline to day 14

  • Number of participants that demonstrate improvement in fever

    From baseline to day 14

  • Number of participants that demonstrate improvement in treatment tolerance

    From baseline to day 14

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

    Day 14

  • Number of participants that have Antibiotic-Associated Adverse Effects

    From baseline to day 14

  • +4 more secondary outcomes

Study Arms (2)

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

Interventions

5 day short course antibiotic treatmentDRUG

Participants will receive oral penicillin or amoxicillin for 5 days

5 day short course antibiotic treatment
10 day standard of care antibiotic treatmentDRUG

Participants will receive oral penicillin or amoxicillin for 10 days

10 day standard of care antibiotic treatment

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Guliz Erdem, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guliz Erdem, MD

CONTACT

(713) 500-5806Guliz.Erdem@uth.tmc.edu

Gabriela Del Bianco

CONTACT

(713) 500-5806Gabriela.Del.Bianco@uth.tmc.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 21, 2026

First Posted

September 29, 2026

Study Start

September 28, 2026

Primary Completion (Estimated)

April 28, 2029

Study Completion (Estimated)

September 28, 2029

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)