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RecruitingNCT06982105Updated Jul 29, 2026

Trimethoprim-sulfamethoxazole vs. Clindamycin for the Treatment of Children With Invasive MRSA Infections

A Phase 4 interventional study of Trimethoprim Sulfamethoxazole in Methicillin Resistant Staphylococcus Aureus, Osteomyelitis Acute and Septic Arthritis, sponsored by Indiana University. Recruiting at 1 site in United States. Open to participants aged 2 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Indiana University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 5 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
2 Months to 18 Years
Sex
All
01

Study summary

The goal of this clinical trial is to learn if trimethoprim-sulfamethoxazole (TMP-SMX) works to treat invasive infections due to methicillin-resistant Staphylococcus aureus (MRSA) in children. It will also learn about the safety of TMP-SMX in the treatment of children with invasive MRSA infections. The main questions it aims to answer are:

-Is TMP-SMX effective at successfully treating children with invasive infections due to MRSA? What are the side effects of TMP-SMX in children taking it for invasive infections due to MRSA?

Researchers will compare TMP-SMX to a clindamycin (a commonly prescribed antibiotic for the treatment of MRSA in children) to see if TMP-SMX works better, worse or the same as clindamycin for children with invasive infections due to MRSA.

Participants will:

Take TMP-SMX or clindamycin for the treatment of their invasive infection due to MRSA.

Will follow up with the provider treating their invasive infection at the discretion of the treating provider.

Keep a diary of their symptoms and any side effects of the medicine

02

Conditions studied

  • Methicillin Resistant Staphylococcus Aureus
  • Osteomyelitis Acute
  • Septic Arthritis
  • Orbital Cellulitis
  • Facial Cellulitis
  • Mastoiditis
  • Cervical Adenitis
  • Retropharyngeal Abscess
  • Peritonsillar Abscess

Keywords

  • Methicillin Resistant Staphylococcus aureus
  • Osteomyelitis
  • Septic Arthritis
  • Osteoarticular infection
  • Head and Neck infection
  • Trimethoprim sulfamethoxazole
  • clindamycin
  • pediatric
03

In context

Arthritis, Infectious

51 studies on the registry are indexed under Arthritis, Infectious; 12 are open to participants now.

This study's planned enrollment of 100 is above the median of 41 across 21 interventional studies indexed under Arthritis, Infectious.

Browse Arthritis, Infectious studies →

Lead sponsor

Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.

Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Enrollment in another interventional study or receipt of 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    TMP-SMX

    Trimethoprim-sulfamethoxazole * For osteoarticular infections- 4-5 mg/kg/dose (based on TMP) PO every 8 hours (max dose 320mg/dose) * For head and neck infections- 5-6 mg/kg/dose (based on TMP PO every 12 hours (max dose 320mg/dose) Duration will be at the discretion of the treating provider

    Drug: Trimethoprim Sulfamethoxazole

  • Active comparator
    Clindamycin

    13 mg/kg/dose PO every 8 hours (max 600mg/dose) Duration will be at the discretion of the treating provider

    Drug: Trimethoprim Sulfamethoxazole

Interventions

  • DrugTrimethoprim Sulfamethoxazole

    * For osteoarticular infections- 4-5 mg/kg/dose (based on TMP) PO every 8 hours (max dose 320mg/dose) * For head and neck infections- 5-6 mg/kg/dose (based on TMP PO every 12 hours (max dose 320mg/dose) Duration will be at the discretion of the treating provider

06

What researchers measure

Primary outcomes

  1. Number of Participants with Treatment Success

    Compare number of participants with treatment success vs. failure at 6 months post hospitalization

    Time frame: 6 months post hospitalization

Secondary outcomes

  1. Number of Participants with Treatment Success at 6 weeks post-hospitalization

    Compare number of participants with treatment success vs. failure at 6 weeks

    Time frame: 6 weeks post hospitalization

  2. Number of Participants who experience an antibiotic-related adverse events (AEs)

    Compare number and severity of AEs between groups graded based on common terminology criteria for adverse events v5.0

    Time frame: 6 months post hospitalization

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06982105
Lead sponsor
Indiana University
Responsible party
James Wood (Assistant Professor of Pediatrics, Indiana University) — Principal investigator
First posted
May 21, 2025
Start date
May 20, 2025
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Jul 29, 2026

Study contacts

Mary Stumpf
Contact
mestumpf@iu.edu
317-274-8801
James Wood, MD
principal investigator · Indiana University

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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