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Can a common antibiotic beat MRSA in kids? a trial puts TMP-SMX to the test

NCT ID NCT06982105

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial compares two oral antibiotics—trimethoprim-sulfamethoxazole (TMP-SMX) and clindamycin—to see which works better for children with invasive MRSA infections, such as bone, joint, or deep tissue infections. About 100 children aged 60 days to 18 years will take one of the drugs and be monitored for treatment success and side effects over six months. The goal is to determine if TMP-SMX is a safe and effective alternative to clindamycin.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trimethoprim-sulfamethoxazole (TMP-SMX) compared to clindamycin, both antibiotics
What this could lead to
If TMP-SMX proves as effective as clindamycin, it could offer a safe, alternative oral antibiotic for children with serious MRSA infections.
What could go wrong
This is a Phase 4 trial with 100 children, so results may not apply to all cases. TMP-SMX may cause side effects or be less effective than clindamycin.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 months to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 60 days to 18 years of age (inclusive) at the time of oral step down treatment 2. Diagnosed by the clinical team with OAI or HNI: * OAI- at least 1 focal finding and 1 systemic finding OR radiographic confirmation of OAI * Focal finding- pain/swelling over a bone/joint, or restricted movement/failure to bear weight * Systemic finding- fever \>38oC, or elevated c-reactive protein (CRP) or elevated erythrocyte sedimentation rate. (ESR) or elevated white blood cell count (WBC) or elevated WBC in synovial fluid OR * Radiographic confirmation- findings consistent with osteomyelitis or septic arthritis - Plain radiograph, MRI, CT or ultrasound, bone scan result indicating abnormal bone, subperiosteal or bone marrow findings consistent with infection * HNI- at least 1 focal finding and 1 systemic finding OR radiographic confirmation of HNI * Focal finding- facial pain or redness, eye pain or proptosis, neck or throat pain or swelling, ear pain or proptosis * Systemic finding- fever \>38oC, or elevated CRP or elevated ESR or elevated WBC OR * Radiographic confirmation- findings consistent with facial/orbital cellulitis, cervical lymphadenitis, mastoiditis, or deep neck infection/abscess (including peritonsillar, retro- and para-pharyngeal. Plain radiograph, MRI, CT or ultrasound, bone scan result indicating abnormal findings consistent with infection 3. Treated by the clinical team for confirmed MRSA or suspected MRSA infection * Confirmed MRSA- positive culture for MRSA from a sterile body fluid (e.g., blood, abscess, bone, synovial fluid, or other surgical specimen) * Suspected MRSA- treatment for MRSA by the clinical team without microbiologic confirmation (e.g., negative cultures) 4. Currently ready or planned to be transitioned to oral antibiotic therapy by the clinical team 5. OAI or HNI symptoms \< 14 days at the time of hospital admission Exclusion Criteria: 1. Enrollment in another interventional study or receipt of investigational drug as part of a research trial within the past 30 days. 2. Known cancer, acquired or primary (including sickle cell anemia or G6PD deficiency) immunodeficiency 3. Underlying bone disease, presence of hardware /implantable device in affected bone/joint 4. Infection (OAI or HNI) resulting from penetrating wounds, open fractures, major trauma, foreign body or post-operative infection. 5. Spinal osteomyelitis 6. Underlying chronic renal, gastrointestinal, liver, or heart disease that would be expected to potentially affect absorption or the metabolism of assigned drug 7. Inability to take medicine by mouth, gastrostomy, jejunostomy or nasogastric tube 8. Received intravenous antibiotic therapy as the treatment for OAI or HNI \>14 days. 9. Inability or unwilling to consent 10. Any social or medical conditions judged by the study clinician to preclude participation because it could negatively affect the participant. 11. Allergy to both TMP-SMX and clindamycin 12. Known MRSA isolate resistant to both TMP-SMX and clindamycin 13. Patient is known to be pregnant at the time of enrollment

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Riley Hospital for Children

    RECRUITING

    Indianapolis, Indiana, 46202, United States

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