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NCT02569541 · ClinicalTrials.gov registry record · Phase 2

Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections

A Phase 2 study, sponsored by Arrevus.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target

NCT02569541: Completed Phase 2 study, sponsored by Arrevus.

NCT02569541 is a Phase 2 study that has completed, run by Arrevus. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT02569541, a Phase 2 study, has completed, sponsored by Arrevus.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study Summary

To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.

Primary Outcome

Number of participants in the intent to treat (ITT) analysis set who meet all the criteria for clinical success at the 6-Month Visit. Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of

Interventions

  • DRUG sodium fusidate

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2015-12
Est. Completion 2019-02-21
Phase Phase 2
Arrevus

4 total trials

What the finished NCT02569541 record still lists

NCT02569541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 1 intervention - of which sodium fusidate is the first listed.

NCT02569541 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02569541 about?

NCT02569541 is a clinical study titled "Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections". To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.

What is the current status of trial NCT02569541?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2015-12. Estimated completion is 2019-02-21.

What interventions are being tested in trial NCT02569541?

The interventions under investigation include: sodium fusidate (DRUG).

Who is sponsoring clinical trial NCT02569541?

This trial is sponsored by Arrevus, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02569541's enrollment target sits among peer trials

30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02569541, the US trial registry maintained by the National Library of Medicine. NCT02569541 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.