Methicillin Resistant Staphylococcus AureusPhase 4NCT06982105
Trimethoprim-sulfamethoxazole vs. Clindamycin for the Treatment of Children With Invasive MRSA Infections
A Phase 4 study testing Trimethoprim Sulfamethoxazole in people with Methicillin Resistant Staphylococcus Aureus and Osteomyelitis Acute, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Methicillin Resistant Staphylococcus Aureus, Osteomyelitis Acute, Septic Arthritis
- What is being tested?
- Trimethoprim Sulfamethoxazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2025to Jun 2027
- 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 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 60 days to 18 years of age (inclusive) at the time of oral step down treatment
- 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
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- 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
- 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)
- Currently ready or planned to be transitioned to oral antibiotic therapy by the clinical team
- OAI or HNI symptoms < 14 days at the time of hospital admission
Who cannot join
- Enrollment in another interventional study or receipt of investigational drug as part of a research trial within the past 30 days.
- Known cancer, acquired or primary (including sickle cell anemia or G6PD deficiency) immunodeficiency
- Underlying bone disease, presence of hardware /implantable device in affected bone/joint
- Infection (OAI or HNI) resulting from penetrating wounds, open fractures, major trauma, foreign body or post-operative infection.
- Spinal osteomyelitis
- Underlying chronic renal, gastrointestinal, liver, or heart disease that would be expected to potentially affect absorption or the metabolism of assigned drug
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- Inability to take medicine by mouth, gastrostomy, jejunostomy or nasogastric tube
- Received intravenous antibiotic therapy as the treatment for OAI or HNI >14 days.
- Inability or unwilling to consent
- Any social or medical conditions judged by the study clinician to preclude participation because it could negatively affect the participant.
- Allergy to both TMP-SMX and clindamycin
- Known MRSA isolate resistant to both TMP-SMX and clindamycin
- Patient is known to be pregnant at the time of enrollment
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, 1 recruiting
- Recruiting
Riley Hospital for Children
Indianapolis, Indiana, 46202
James B Wood, MD, woodjb@iu.edu
About this study
Official title: Comparing Optimal Step-down Therapy for Children With Invasive MRSA Trimethoprim-Sulfamethoxazole vs. Clindamycin for the Treatment of Children With Invasive MRSA Infections
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?
Read more
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
- Conditions
- Methicillin Resistant Staphylococcus Aureus, Osteomyelitis Acute, Septic Arthritis, Orbital Cellulitis, Facial Cellulitis, Mastoiditis
- Being tested
- Trimethoprim Sulfamethoxazole
- Keywords
- Methicillin Resistant Staphylococcus aureus, Osteomyelitis, Septic Arthritis, Osteoarticular infection, Head and Neck infection, Trimethoprim sulfamethoxazole, clindamycin, pediatric
- Medical subject headings
- Arthritis, Infectious, Orbital Cellulitis, Mastoiditis, Retropharyngeal Abscess, Peritonsillar Abscess, Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimethoprim SulfamethoxazoleDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| TMP-SMX | Experimental | 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 Receives: Drug: Trimethoprim Sulfamethoxazole |
| Clindamycin | Active comparator | 13 mg/kg/dose PO every 8 hours (max 600mg/dose) Duration will be at the discretion of the treating provider Receives: Drug: Trimethoprim Sulfamethoxazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Success
Compare number of participants with treatment success vs. failure at 6 months post hospitalization
Measured: 6 months post hospitalization
Secondary outcomes (2)
Number of Participants with Treatment Success at 6 weeks post-hospitalization
Compare number of participants with treatment success vs. failure at 6 weeks
Measured: 6 weeks post hospitalization
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
Measured: 6 months post hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start20 May 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methicillin Resistant Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Wood, Indiana University
- Investigators
- James Wood, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982105
- Sponsor's protocol ID
- 26098
- Status last verified
- Jul 2026
- First submitted
- 28 Mar 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Optimal Step-down Therapy for Children With Invasive MRSA Trimethoprim-Sulfamethoxazole vs. Clindamycin for the Treatment of Children With Invasive MRSA Infections
- ClinicalTrials.gov ID
- NCT06982105
- Acronym / sponsor ID
- 26098
- Conditions
- Methicillin Resistant Staphylococcus Aureus, Osteomyelitis Acute, Septic Arthritis, Orbital Cellulitis, Facial Cellulitis, Mastoiditis
- Keywords
- Methicillin Resistant Staphylococcus aureus, Osteomyelitis, Septic Arthritis, Osteoarticular infection, Head and Neck infection, Trimethoprim sulfamethoxazole, clindamycin, pediatric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 May 2025 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMP-SMX | Experimental | Drug: Trimethoprim SulfamethoxazoleTrimethoprim-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 |
| Clindamycin | Active comparator | Drug: Trimethoprim Sulfamethoxazole13 mg/kg/dose PO every 8 hours (max 600mg/dose) Duration will be at the discretion of the treating provider |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- 60 days to 18 years of age (inclusive) at the time of oral step down treatment
- Diagnosed by the clinical team with OAI or HNI:
- Treated by the clinical team for confirmed MRSA or suspected MRSA infection
- Currently ready or planned to be transitioned to oral antibiotic therapy by the clinical team
- OAI or HNI symptoms < 14 days at the time of hospital admission
Key exclusion criteria (13 listed)
- Enrollment in another interventional study or receipt of investigational drug as part of a research trial within the past 30 days.
- Known cancer, acquired or primary (including sickle cell anemia or G6PD deficiency) immunodeficiency
- Underlying bone disease, presence of hardware /implantable device in affected bone/joint
- Infection (OAI or HNI) resulting from penetrating wounds, open fractures, major trauma, foreign body or post-operative infection.
- Spinal osteomyelitis
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 |
|---|---|---|
| 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 | Clindamycin, TMP-SMX |
Primary outcome
Number of Participants with Treatment Success
Time frame: 6 months post hospitalization
Compare number of participants with treatment success vs. failure at 6 months post hospitalization
2 secondary outcomes
Number of Participants with Treatment Success at 6 weeks post-hospitalization
Time frame: 6 weeks post hospitalization
Number of Participants who experience an antibiotic-related adverse events (AEs)
Time frame: 6 months post hospitalization
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 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
James Wood, MD principal investigator
Indiana University
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 Trimethoprim Sulfamethoxazole in people with Methicillin Resistant Staphylococcus Aureus and Osteomyelitis Acute, run by Indiana University 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 15 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 29 Jul 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 Mary Stumpf (317-274-8801, mestumpf@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Success (time frame: 6 months post hospitalization). 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 Jul 2026.