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Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rifampin
Azithromycin
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Medical School

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 7, 2002
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
National Multiple Sclerosis Society
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1. Study Identification

Unique Protocol Identification Number
NCT00043264
Brief Title
Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis
Official Title
Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
National Multiple Sclerosis Society

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rifampin
Intervention Type
Drug
Intervention Name(s)
Azithromycin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients with unequivocal diagnosis of multiple sclerosis and have evidence of C. pneumoniae infection in the cerebral spinal fluid
Facility Information:
Facility Name
University of Texas Medical School
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis

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