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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01756924
Other study ID # CE06-200
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date December 2012
Est. completion date July 2014

Study information

Verified date April 2019
Source Arrevus Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


Recruitment information / eligibility

Status Terminated
Enrollment 14
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- History of hypersensitivity or intolerability to sodium fusidate (FucidinĀ®), 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CEM-102

IV or Oral standard of care antibiotics

Rifampin


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Arrevus Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 to 6 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06456424 - Bacteriophage Therapy for Methicillin-Sensitive Staphylococcus Aureus Prosthetic Joint Infection Phase 1/Phase 2