Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00043264
• Other study ID #: NCRR-M01RR02558-0176
• Status: Completed
• Phase: Phase 2
• First received: August 7, 2002
• Last updated: June 23, 2005

Study information

• Verified date: December 2003
• Source: National Center for Research Resources (NCRR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Patients with unequivocal diagnosis of multiple sclerosis and have evidence of C. pneumoniae infection in the cerebral spinal fluid

Study Design

Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Rifampin

• Azithromycin

Locations

Country	Name	City	State
United States	University of Texas Medical School	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States,