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| Descriptive Information Fields | |
| Brief Title † | Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis |
| Official Title † | Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis |
| Brief Summary | Multiple sclerosis (MS) is an inflammatory, demyelinating disease which affects the central nervous system (CNS). The etiology of MS is unknown, although the immune system appears to play a role. Many different infectious agents have been proposed as potential causes for MS, including Epstein-Barr virus, human herpesvirus 6, and coronaviruses. Recently Dr. Sriram at Vanderbilt University has found evidence for active Chlamydia pneumonia infection in the CNS of MS patients. These findings have been replicated in part by other laboratories. The purpose of the current study is to test whether antibiotic treatment aimed at eradicating Chlamydia infection will reduce the disease activity in MS. The primary outcome measure will be reduction in new enhancing MS lesions on brain MRI. Forty patients will be entered into the trial. To be eligible, patients must have evidence of chlamydia infection in their spinal fluid and enhancing lesions on their pre-randomization MRI scans. Patients who meet these criteria will be randomized to either placebo or antibiotic therapy, and followed for 6 months on treatment. |
| Detailed Description | |
| Study Phase | Phase II |
| Study Type † | Interventional |
| Study Design † | Treatment, Double-Blind, Placebo Control, Parallel Assignment |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | Multiple Sclerosis |
| Intervention † | Drug: Rifampin Drug: Azithromycin |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 40 |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | Patients with unequivocal diagnosis of multiple sclerosis and have evidence of C. pneumoniae infection in the cerebral spinal fluid |
| Gender | Both |
| Ages | 18 Years to 65 Years |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00043264 |
| Organization ID | NCRR-M01RR02558-0176 |
| Secondary IDs †† | |
| Study Sponsor † | National Center for Research Resources (NCRR) |
| Collaborators †† | National Multiple Sclerosis Society |
| Investigators † | |
| Information Provided By | National Center for Research Resources (NCRR) |
| Verification Date | December 2003 |
| First Received Date † | August 7, 2002 |
| Last Updated Date | June 23, 2005 |