New drug combo aims to beat hard-to-treat bone infections
NCT ID NCT07435051
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a bone-strengthening drug (bisphosphonate) to a standard antibiotic (vancomycin) can better control chronic bone infections that are hard to treat. About 280 adults with a specific type of bone infection will be randomly assigned to get either the combination or the antibiotic alone. The main goal is to see if the infection is under control after 6 months, based on normal temperature, healed wounds, normal blood tests, and new bone growth on X-rays.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 280 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients diagnosed with chronic osteomyelitis (Cierny-Mader type I and III) based on clinical manifestations (local pain, redness and swelling, sinus tract formation, etc.), laboratory findings (elevated white blood cell count, neutrophil ratio, CRP and ESR, positive pathogenic bacterial culture), and typical imaging features (X-ray, CT, MRI), and who require debridement surgery. * Pathogen susceptibility testing confirms the causative organism as Staphylococcus aureus or methicillin-resistant Staphylococcus aureus (MRSA). * Subjects aged 18 to 65 years. * Male or female subjects. * Written informed consent is obtained from the subject and their family members. * The study protocol has been approved by the hospital ethics committee. * Willing and able to comply with the study protocol, scheduled follow-up, and toxicity management as judged by the study investigators. Exclusion Criteria: * Known hypersensitivity or resistance to the components of the product (bisphosphonates, vancomycin)NCBI. * Currently on long-term bisphosphonate therapy, or having received intravenous bisphosphonates within the past year. * Patients with systemic infectious diseases (sepsis, bacteremia, or septicemia) or immunocompromised status (HIV/AIDS or receiving immunosuppressive medications). * Patients with granulocytopenia (\< 1×10⁹/L). * Patients with poorly controlled diabetes (HbA1c \> 8%). * History of gastrointestinal bleeding or active hemoptysis (at least half a teaspoon of bright red blood) within 3 weeks prior to the first dose of study medication. * Patients with unexplained hypocalcemia. * Patients with renal impairment (serum creatinine \> 177 μmol/L or eGFR \< 50 mL/min). * Females who are breastfeeding or pregnant at screening or baseline. * Currently enrolled in another clinical trial, or having received any investigational drug or device within 30 days prior to providing informed consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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the Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China