Oral Antibiotics for Osteomyelitis

(OSTEO Trial)

Not yet recruiting at 2 trial locations

Overseen By Christopher Kandel, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Michael Garron Hospital

Must be taking: Oral antibiotics

Disqualifiers: Prior OSTEO trial, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two types of oral antibiotics to determine which is more effective for treating bone infections in the leg and foot. It will test whether oral beta-lactam antibiotics are as effective as non-beta-lactam antibiotics. Participants should have ongoing bone infections below the knee and require at least 28 more days of antibiotic treatment.

As a Phase 4 trial, the treatment has already received FDA approval and proven effective, helping to understand its benefits for more patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop your current medications, but it does require that you switch to oral antibiotics for the infection. It's best to discuss your current medications with the trial team to see if any changes are needed.

What is the safety track record for these treatments?

Research shows that oral beta-lactam antibiotics are usually safe and effective for treating bone infections. Past studies found that these antibiotics can be used safely for extended periods, particularly for conditions like osteomyelitis, a type of bone infection. Patients have experienced good results with few side effects when using these antibiotics.

Similarly, oral non-beta-lactam antibiotics are also safe and effective. Studies have shown they work well for bone and joint infections. These antibiotics are often administered after a short period of intravenous (IV) treatment, and many patients transition to oral treatment smoothly.

Both types of antibiotics have been widely used and are considered safe for treating bone infections based on previous research. Participants can feel confident about the safety of these treatments in the trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for osteomyelitis because they offer an oral option, which is a significant shift from the current standard that often involves intravenous antibiotics. The Oral Beta-Lactam Antibiotic provides a potentially more convenient and less invasive alternative for patients, possibly improving compliance and outcomes. The Oral Non-Beta-Lactam Antibiotic serves as a vital comparator, helping to explore the efficacy of different oral antibiotic classes. This could pave the way for more tailored, patient-friendly treatments for bone infections.

What evidence suggests that this trial's treatments could be effective for bone infections?

This trial will compare the effectiveness of oral beta-lactam antibiotics with oral non-beta-lactam antibiotics for treating osteomyelitis. Research has shown that oral antibiotics can be as effective as IV antibiotics for bone infections. Studies suggest that oral beta-lactam antibiotics work well for these infections and might match the effectiveness of other antibiotic types. Non-beta-lactam antibiotics have also achieved success, with many patients recovering from their infections. Both types of oral antibiotics show promise for treating diabetic foot infections, offering a reliable alternative to IV antibiotics. Overall, evidence supports the effectiveness of both oral beta-lactam and non-beta-lactam antibiotics in treating bone infections. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

Adults over 18 with bone infections below the knee, who need at least 28 more days of oral antibiotics. They must not have been treated for the same infection in the past 6 months and should not be pregnant or breastfeeding. Participants cannot join if they're allergic to trial drugs, resistant to them, or have medical reasons preventing their use.

Inclusion Criteria

I am over 18 years old.

I have a bone infection in my leg below the knee.

I will be on antibiotics for at least 28 more days from now.

Exclusion Criteria

Prior enrollment in the OSTEO trial

Prior antibiotic treatment for the same infection in the past 6 months

Known pregnancy, planning to become pregnant during the study period, or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oral beta-lactam or non-beta-lactam antibiotics for the treatment of bone infections

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oral Beta-Lactam Antibiotic
• Oral Non-Beta-Lactam Antibiotic

Trial Overview

The study is testing whether oral beta-lactam antibiotics are as effective as non-beta-lactam ones for treating leg and foot bone infections. Initially, it's checking if enough people can join and follow through with the study before expanding to fully compare these antibiotic classes.

How Is the Trial Designed?

Group I: Oral Beta-Lactam Antibiotic Experimental Treatment 1 Intervention

Group II: Oral Non-Beta-Lactam Antibiotic Active Control 1 Intervention

Who Is Running the Clinical Trial?

Michael Garron Hospital

Lead Sponsor

Trials

16

Recruited

7,200+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

The Ottawa Hospital Research Institute

Collaborator

Trials

3

Recruited

1,700+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10812599/

A Review of the Clinical Utilization of Oral Antibacterial ...

There was resolution in 22 (65%) patients, improvement in 5 (14%), and failure in 7 (21%); thus ciprofloxacin was recommended as an oral alternative to IV ...

2.

academic.oup.com

academic.oup.com/ofid/article/11/12/ofae683/7902026

Implementing Oral Antibiotics for Bone and Joint Infections

An institutional guideline was effective in increasing the proportion of patients with bone and joint infections discharged on oral antibiotics. We observed ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07266753

Comparison of Oral Antibiotics For Bone Infections ...

The hypothesis is that oral beta-lactam antibiotics work as well as oral non-beta-lactam antibiotics to treat these infections. The first step ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1201971205000123

Antibiotic treatment of osteomyelitis: what have we learned ...

Available evidence suggests that oral antibiotic therapy can be as effective as parenteral treatments. The evidence is strongest for fluoroquinolones, because ...

5.

frontiersin.org

frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.975666/full

Comparing the efficacy of different antibiotic regimens on ...

The primary outcomes were the effective rates of sterility (sterility rates after treatment), radiological grades, and bacteria counts. The ...

6.

icjournal.org

icjournal.org/DOIx.php?id=10.3947/ic.2019.51.3.284

Antibiotic Treatment of Vertebral Osteomyelitis caused by ...

During antibiotic therapy, the median number of antibiotics given to each patient was 3.5 (IQR 2‒5). All 100 patients were treated, initially or ...