Prosthetic Joint Infections of HipPhase 2NCT01756924
Safety and Efficacy of CEM-102 With Rifampin Compared to Standard Therapy in Patients With Prosthetic Joint Infections or Spacer Infection
A Phase 2 study testing CEM-102 and Rifampin in people with Prosthetic Joint Infections of Hip and Prosthetic Joint Infections of Knee, run by Arrevus Inc. at 13 sites in United States.
Trial summary
To determine if oral antibiotic treatment with CEM-102 and Rifampin is as effective and safe as the standard of care antibiotic therapy for the treatment of hip and knee prosthetic joint or spacer infections Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Joint Infections of Hip, Prosthetic Joint Infections of Knee, Infected Spacers
- What is being tested?
- CEM-102 and Rifampin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 13 sitesUnited States
- Study dates
- Dec 2012to Jul 2014
- Phase
- Phase 2
- 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
- Prosthetic knee or hip joint infection
- Infected joint spacer
- Able to swallow tablets
- Able to voluntarily sign the informed consent form
- Females of childbearing potential must use an acceptable method of birth control
- The joint infection must be attributed to bacterial pathogens sensitive to fusidic acid and rifampin
Who cannot join
- History of hypersensitivity or intolerability to sodium fusidate (Fucidin®), or to rifampin
- Females who are pregnant or lactating
- Requirement for significant immunosuppression
- Bacteremia
- Known cirrhosis or decompensated liver disease
- Current treatment for HIV or Hepatitis C
- Seizure disorder, requiring anti-convulsants
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Study site
Baltimore, Maryland, 21215
Study site
Baltimore, Maryland, 21218
Study site
Boston, Massachusetts, 02215
Study site
Charleston, South Carolina, 29425
Study site
Durham, North Carolina, 27710
Study site
Houston, Texas, 77030
Study site
Houston, Texas, 77043
Study site
Philadelphia, Pennsylvania, 19107
Study site
Pittsburgh, Pennsylvania, 15232
Study site
Sarasota, Florida, 34232
Study site
Savannah, Georgia, 31419
Study site
Syracuse, New York, 13507
Study site
Tamarac, Florida, 33321
About this study
To determine if oral antibiotic treatment with CEM-102 and Rifampin is as effective and safe as the standard of care antibiotic therapy for the treatment of hip and knee prosthetic joint or spacer infections
- Being tested
- CEM-102, IV or Oral standard of care antibiotics, Rifampin
- Keywords
- prosthetic joint infection, hip arthroplasty, MRSA, knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEM-102Drug
Also called fusidic acid
IV or Oral standard of care antibioticsDrug
Also called vancomycin, daptomycin, linezolid, rifampin
RifampinDrug
| Study group | Role | What they receive |
|---|---|---|
| CEM-102 plus Rifampin | Experimental | Not described Receives: Drug: CEM-102; Drug: Rifampin |
| Standard of Care | Active comparator | Not described Receives: Drug: IV or Oral standard of care antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial eradication of joint infection
Clinical success is defined as the absence of persistent infection in a patient who did not receive alternative antibiotic therapy targeting the infection.
Measured: 3 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: This study has been terminated; alternative study designs are being considered. Fusidic acid remains available under an Expanded Access Protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prosthetic Joint Infections of HipStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrevus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756924
- Sponsor's protocol ID
- CE06-200
- Status last verified
- Apr 2019
- First submitted
- 18 Dec 2012
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Pushkin R, Iglesias-Ussel MD, Keedy K, MacLauchlin C, Mould DR, Berkowitz R, Kreuzer S, Darouiche R, Oldach D, Fernandes P. A Randomized Study Evaluating Oral Fusidic Acid (CEM-102) in Combination With Oral Rifampin Compared With Standard-of-Care Antibiotics for Treatment of Prosthetic Joint Infections: A Newly Identified Drug-Drug Interaction. Clin Infect Dis. 2016 Dec 15;63(12):1599-1604. doi: 10.1093/cid/ciw665. Epub 2016 Sep 28.
PubMed 27682068
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of CEM-102 With Rifampin Compared to Standard Therapy in Patients With Prosthetic Joint Infections or Spacer Infection
- ClinicalTrials.gov ID
- NCT01756924
- Acronym / sponsor ID
- CE06-200
- Keywords
- prosthetic joint infection, hip arthroplasty, MRSA, knee arthroplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study has been terminated; alternative study designs are being considered. Fusidic acid remains available under an Expanded Access Protocol.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Arrevus Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 28 Dec 2012 (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.
To determine if oral antibiotic treatment with CEM-102 and Rifampin is as effective and safe as the standard of care antibiotic therapy for the treatment of hip and knee prosthetic joint or spacer infections
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEM-102 plus Rifampin | Experimental | Drug: CEM-102, Drug: Rifampin |
| Standard of Care | Active comparator | Drug: IV or Oral standard of care antibiotics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Prosthetic knee or hip joint infection
- Infected joint spacer
- Able to swallow tablets
- Able to voluntarily sign the informed consent form
- Females of childbearing potential must use an acceptable method of birth control
Key exclusion criteria (7 listed)
- History of hypersensitivity or intolerability to sodium fusidate (Fucidin®), or to rifampin
- Females who are pregnant or lactating
- Requirement for significant immunosuppression
- Bacteremia
- Known cirrhosis or decompensated liver disease
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 |
|---|---|---|
| CEM-102Also: fusidic acid | Drug | CEM-102 plus Rifampin |
| IV or Oral standard of care antibioticsAlso: vancomycin, daptomycin, linezolid, rifampin | Drug | Standard of Care |
| Rifampin | Drug | CEM-102 plus Rifampin |
Primary outcome
Bacterial eradication of joint infection
Time frame: 3 to 6 months
Clinical success is defined as the absence of persistent infection in a patient who did not receive alternative antibiotic therapy targeting the infection.
Results and safety
The study was stopped early (reason given: This study has been terminated; alternative study designs are being considered. Fusidic acid remains available under an Expanded Access Protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Derived from this study: PubMed 27682068Pushkin R, Iglesias-Ussel MD, Keedy K, MacLauchlin C, Mould DR, Berkowitz R, Kreuzer S, Darouiche R, Oldach D, Fernandes P. A Randomized Study Evaluating Oral Fusidic Acid (CEM-102) in Combination With Oral Rifampin Compared With Standard-of-Care Antibiotics for Treatment of Prosthetic Joint Infections: A Newly Identified Drug-Drug Interaction. Clin Infect Dis. 2016 Dec 15;63(12):1599-1604. doi: 10.1093/cid/ciw665. Epub 2016 Sep 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CEM-102 and Rifampin in people with Prosthetic Joint Infections of Hip and Prosthetic Joint Infections of Knee, run by Arrevus Inc. at 13 sites 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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: This study has been terminated; alternative study designs are being considered. Fusidic acid remains available under an Expanded Access Protocol.). Results are not available in the source record.
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?
Bacterial eradication of joint infection (time frame: 3 to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01756924, which also lists 1 linked publication.
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 19 Apr 2019.