OsteomyelitisPhase 3NCT00324922
Vancomycin Or Trimethoprim/Sulfamethoxazole for Methicillin-resistant Staphylococcus Aureus Osteomyelitis
A Phase 3 study testing trimethoprim-sulfamethoxazole and vancomycin in people with Osteomyelitis and Methicillin-resistant Staphylococcus Aureus, run by University of Washington at 1 site in United States.
Trial summary
The primary question of this study is to understand if trimethoprim-sulfamethoxazole (TMP-SMX) is as effective as vancomycin for treating methicillin-resistant Staphylococcus aureus (MRSA) osteomyelitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteomyelitis, Methicillin-resistant Staphylococcus Aureus
- What is being tested?
- trimethoprim-sulfamethoxazole and vancomycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2006to 1 May 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Culture-proven MRSA, obtained in operating room or sterile biopsy procedure from bone site. The infection and sampling site can either be within bone or a deep soft-tissue site that is contiguous with bone; OR radiographic abnormality consistent with osteomyelitis in conjunction with a positive blood culture for MRSA.
- Surgical debridement of infection site, as needed.
- Subject is capable of providing written informed consent.
- Subject is at least 18 years of age.
- Subject capable of receiving outpatient parenteral therapy for 12 weeks.
Who cannot join
- Hypersensitivity to TMP-SMX or vancomycin.
- S. aureus resistant to TMP-SMX or vancomycin.
- Osteomyelitis that develops directly from a chronic, open wound.
- Polymicrobial culture(the only exception is if coagulase-negative staphylococcus is present in the culture and the clinical assessment is that it is a contaminant).
- Subject has a positive pregnancy test at study enrollment.
- Convicted felon currently in prison.
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- Baseline renal or hepatic insufficiency that would preclude administration of study drugs.
- Active injection drug use without safe conditions to administer intravenous antibiotics for 3 months.
- Anticipated use of antibiotics for greater than 14 days for an infection other than osteomyelitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized Trial Comparing Vancomycin With Trimethoprim/Sulfamethoxazole for the Treatment of MRSA Osteomyelitis
The primary question of this study is to understand if trimethoprim-sulfamethoxazole (TMP-SMX) is as effective as vancomycin for treating methicillin-resistant Staphylococcus aureus (MRSA) osteomyelitis.
Read the detailed description
Treatment of osteomyelitis is hampered by a paucity of evidence from prospective clinical trials with randomized treatment arms. Furthermore, previous randomized or observational trials have enrolled small numbers of subjects and thus often had non-definitive findings. One of the most common causes of osteomyelitis is Staphylococcus aureus. Over the past 10 years, rates of methicillin-resistant S. aureus (MRSA) have risen dramatically. Vancomycin is currently the treatment of choice for treating MRSA. While vancomycin is effective, it is only available in intravenous formulation and has renal and bone marrow toxicities. There is a critical need for effective, oral, cheap drugs for the treatment of MRSA. Trimethoprim-sulfamethoxazole (TMP-SMX) is a drug with several advantageous properties for the treatment of MRSA osteomyelitis. To address this question regarding optimal treatment of MRSA osteomyelitis, we designed a prospective, randomized trial comparing TMP-SMX with vancomycin for the treatment of MRSA osteomyelitis.
- Being tested
- trimethoprim-sulfamethoxazole, vancomycin
- Keywords
- Vancomycin, Trimethoprim-Sulfamethoxazole Combination
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trimethoprim-sulfamethoxazoleDrug
trimethoprim/sulfamethoxazole 320/1600 mg po bid
vancomycinDrug
1g iv bid
| Study group | Role | What they receive |
|---|---|---|
| Trimethoprim-sulfamethoxazole | Active comparator | trimethoprim-sulfamethoxazole, double strength, 2-3 tabs twice a day by mouth for 6-12 weeks Receives: Drug: trimethoprim-sulfamethoxazole; Drug: vancomycin |
| Vancomycin | Active comparator | Vancomycin, dosage to be determined by serum levels, medication provided by vein and duration 6-12 weeks Receives: Drug: vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure
No clinical or radiographic evidence of infection at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2006 (estimated)
- Study start1 May 2006
- Primary completion1 May 2007
- Study completion1 May 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteomyelitisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Harrington, University of Washington
- Investigators
- Timothy H. Dellitt, MD, Principal investigator, UWJeanne Chan, PharmD, MPH, Principal investigator, UWMatthew Golden, MD, MPH, Principal investigator, UWM. Bradford Henley, MD, Principal investigator, UWJeanne M Marrazzo, MD, MPH, Principal investigator, UWLisa Taitsman, MD, Principal investigator, UWThomas R Hawn, MD, PhD, Principal investigator, UWRobert D Harrington, MD, Principal investigator, UW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324922
- Sponsor's protocol ID
- 27915
- Status last verified
- Apr 2023
- First submitted
- 9 May 2006
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial Comparing Vancomycin With Trimethoprim/Sulfamethoxazole for the Treatment of MRSA Osteomyelitis
- ClinicalTrials.gov ID
- NCT00324922
- Acronym / sponsor ID
- 27915
- Keywords
- Vancomycin, Trimethoprim-Sulfamethoxazole Combination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 May 2006 (actual)
- Primary completion
- 1 May 2007 (actual)
- Study completion
- 1 May 2007 (actual)
- First posted
- 11 May 2006 (estimated)
- 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 primary question of this study is to understand if trimethoprim-sulfamethoxazole (TMP-SMX) is as effective as vancomycin for treating methicillin-resistant Staphylococcus aureus (MRSA) osteomyelitis.
Detailed description
Treatment of osteomyelitis is hampered by a paucity of evidence from prospective clinical trials with randomized treatment arms. Furthermore, previous randomized or observational trials have enrolled small numbers of subjects and thus often had non-definitive findings. One of the most common causes of osteomyelitis is Staphylococcus aureus. Over the past 10 years, rates of methicillin-resistant S. aureus (MRSA) have risen dramatically. Vancomycin is currently the treatment of choice for treating MRSA. While vancomycin is effective, it is only available in intravenous formulation and has renal and bone marrow toxicities. There is a critical need for effective, oral, cheap drugs for the treatment of MRSA. Trimethoprim-sulfamethoxazole (TMP-SMX) is a drug with several advantageous properties for the treatment of MRSA osteomyelitis. To address this question regarding optimal treatment of MRSA osteomyelitis, we designed a prospective, randomized trial comparing TMP-SMX with vancomycin for the treatment of MRSA osteomyelitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trimethoprim-sulfamethoxazole | Active comparator | Drug: trimethoprim-sulfamethoxazole, Drug: vancomycintrimethoprim-sulfamethoxazole, double strength, 2-3 tabs twice a day by mouth for 6-12 weeks |
| Vancomycin | Active comparator | Drug: vancomycinVancomycin, dosage to be determined by serum levels, medication provided by vein and duration 6-12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Culture-proven MRSA, obtained in operating room or sterile biopsy procedure from bone site. The infection and sampling site can either be within bone or a deep soft-tissue site that is contiguous with bone; OR radiographic abnormality consistent with osteomyelitis in conjunction with a positive blood culture for MRSA.
- Surgical debridement of infection site, as needed.
- Subject is capable of providing written informed consent.
- Subject is at least 18 years of age.
- Subject capable of receiving outpatient parenteral therapy for 12 weeks.
Key exclusion criteria (9 listed)
- Hypersensitivity to TMP-SMX or vancomycin.
- S. aureus resistant to TMP-SMX or vancomycin.
- Osteomyelitis that develops directly from a chronic, open wound.
- Polymicrobial culture(the only exception is if coagulase-negative staphylococcus is present in the culture and the clinical assessment is that it is a contaminant).
- Subject has a positive pregnancy test at study enrollment.
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-sulfamethoxazoletrimethoprim/sulfamethoxazole 320/1600 mg po bid | Drug | Trimethoprim-sulfamethoxazole |
| vancomycin1g iv bid | Drug | Trimethoprim-sulfamethoxazole, Vancomycin |
Primary outcome
Clinical cure
Time frame: 12 months
No clinical or radiographic evidence of infection at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
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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. This study is not recruiting at the moment.
Timothy H. Dellitt, MD principal investigator
UW
Jeanne Chan, PharmD, MPH principal investigator
UW
Matthew Golden, MD, MPH principal investigator
UW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing trimethoprim-sulfamethoxazole and vancomycin in people with Osteomyelitis and Methicillin-resistant Staphylococcus Aureus, run by University of Washington 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 11 Apr 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure (time frame: 12 months). 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 11 Apr 2023.