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New treatment option for Methicillin Resistant Staphylococcus Aureus
Official title Trimethoprim-sulfamethoxazole vs. Clindamycin for the Treatment of Children With Invasive MRSA Infections
ClinicalTrials.gov ID: NCT06982105
What this study is testing
What is Trimethoprim Sulfamethoxazole?
Trimethoprim Sulfamethoxazole is an investigational medicine, being studied as a potential treatment for methicillin resistant staphylococcus aureus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 18
You may be able to join if
- 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...
You likely can't join if
- Enrollment in another treatment 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...
See the full eligibility criteria
- 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...
- 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...
- 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
- Enrollment in another treatment 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 months to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.