Trimethoprim-Sulfamethoxazole for MRSA Infections
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on determining the effectiveness and safety of the antibiotic trimethoprim-sulfamethoxazole (TMP-SMX) for treating children with serious infections caused by MRSA, a type of bacteria resistant to common antibiotics. Researchers will compare TMP-SMX to clindamycin to identify which antibiotic works better for these infections. Children diagnosed with an MRSA infection in their bones, joints, head, or neck and ready to switch to oral antibiotics may be suitable for this study. Participants will take either TMP-SMX or clindamycin, record their symptoms and medication side effects, and have regular follow-ups with their healthcare provider. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand its benefits for more patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your healthcare provider.
What is the safety track record for trimethoprim-sulfamethoxazole and clindamycin?
A previous study used the antibiotic trimethoprim-sulfamethoxazole (TMP-SMX) to treat skin infections caused by MRSA, a type of bacteria. The study found that patients tolerated TMP-SMX well, even at higher doses, suggesting it is generally safe. TMP-SMX is often used for serious MRSA infections and has a history of use in people.
Clindamycin, the other antibiotic, is also well-known and frequently used for MRSA infections in children. As a standard treatment, there is extensive experience with its safety.
Both TMP-SMX and clindamycin have been widely used to treat MRSA, and safety data from their long-term use exist. They are both considered well-tolerated, with side effects manageable in most cases.12345Why are researchers enthusiastic about this study treatment?
Most treatments for MRSA infections, like clindamycin and vancomycin, focus on inhibiting bacterial protein synthesis or cell wall formation. But trimethoprim-sulfamethoxazole (TMP-SMX) works differently, targeting bacterial DNA synthesis, which can be effective even against resistant strains of bacteria. Researchers are excited about TMP-SMX because it offers a potentially more convenient oral dosing schedule, which could improve patient compliance and outcomes. Additionally, its dual mechanism of action may help to prevent the development of further antibiotic resistance.
What evidence suggests that this trial's treatments could be effective for MRSA infections?
This trial will compare the effectiveness of trimethoprim-sulfamethoxazole (TMP-SMX) with clindamycin for MRSA infections. Research has shown that TMP-SMX effectively treats MRSA infections. One study found that TMP-SMX outperformed a placebo, reducing the need for later surgeries. Another study demonstrated that TMP-SMX had similar results to vancomycin, a strong antibiotic, though it was less effective for very severe cases. Despite this, TMP-SMX remains widely used because it targets MRSA effectively. Only 9% of people did not respond well to the treatment, indicating that TMP-SMX is generally effective for MRSA infections.16789
Who Is on the Research Team?
James Wood, MD
Principal Investigator
Indiana University School of Medicine
Are You a Good Fit for This Trial?
This trial is for children with invasive MRSA infections, showing symptoms like pain/swelling over a bone/joint or fever >38°C. They must have lab results indicating infection (like high CRP or WBC) or imaging confirming conditions such as osteomyelitis or cellulitis. Children already being treated for confirmed/suspected MRSA can join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take TMP-SMX or clindamycin for the treatment of their invasive infection due to MRSA
Follow-up
Participants are monitored for treatment success and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Trimethoprim-sulfamethoxazole
Trial Overview
The study tests if trimethoprim-sulfamethoxazole (TMP-SMX) is effective and safe compared to clindamycin in treating children's invasive MRSA infections. Participants will take either TMP-SMX or clindamycin, monitor their symptoms, and report side effects in a diary.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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
13 mg/kg/dose PO every 8 hours (max 600mg/dose) Duration will be at the discretion of the treating provider
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
Citations
Dose of Trimethoprim-Sulfamethoxazole To Treat Skin and ...
The study found that patients with MRSA SSTIs treated with the higher dose of TMP/SMX (320/1,600 mg twice daily) for 7 to 15 days had a similar rate of clinical ...
Trimethoprim-sulfamethoxazole versus vancomycin for ...
Conclusions High dose trimethoprim-sulfamethoxazole did not achieve non-inferiority to vancomycin in the treatment of severe MRSA infections.
Trimethoprim–Sulfamethoxazole versus Placebo for ...
Trimethoprim–sulfamethoxazole was superior to placebo with respect to most secondary outcomes, resulting in lower rates of subsequent surgical ...
Molecular analysis of an increase in trimethoprim ...
We compared the prevalence of phenotypic trimethoprim/sulfamethoxazole resistance in 20 534 clinical Staphylococcus aureus isolates (19 096 MSSA and 1438 MRSA)
Prospective Randomized Trial of Empiric Therapy with ...
The overall clinical failure rate was 9%, with all failures occurring in the trimethoprim-sulfamethoxazole group. However, there was no significant difference ...
Clinical Practice Guidelines by the Infectious Diseases Society ...
Evidence-based guidelines for the management of patients with methicillin-resistant Staphylococcus aureus (MRSA) infections were prepared by an Expert Panel of ...
Trimethoprim-sulfamethoxazole resistance patterns among ...
We reviewed trimethoprim-sulfamethoxazole antibiotic susceptibility testing data among. Staphylococcus aureus using 3 national inpatient ...
MRSA Infection
Few antibiotics are available to treat more serious MRSA infections. These include vancomycin (Vancocin, Vancoled), trimethoprim-sulfamethoxazole (Bactrim, ...
Screening method for trimethoprim/sulfamethoxazole ...
Trimethoprim/sulfamethoxazole (SXT) is used to treat infectious diseases caused by Staphylococcus aureus, including methicillin-resistant S. aureus (MRSA) [1], ...
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