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New drug combo aims to beat hard-to-treat bone infections

NCT ID NCT07435051

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • the Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000, China