Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351273
Status:
COMPLETED
Last Update Posted:
2018-11-13
First Post:
2006-07-10
Brief Title:
Combination Antibiotic Treatment for Reactive Arthritis Caused by Chlamydia Bacteria
Sponsor:
University of South Florida
Organization:
University of South Florida
Study Overview
Official Title:
Phase 3 Trial to Assess the Efficacy of Long-term 6 Months Combination Antibiotics as a Treatment for Chlamydia-induced Reactive Arthritis
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Reactive arthritis also known as Reiters syndrome is a form of arthritis that occurs as a reaction to an infection elsewhere in the body It is characterized by inflammation of the joints tendons urogenital tract and eyes Pain and swelling in the knees ankles and feet are common This study will determine the effectiveness of antibiotic therapy in treating people with chlamydia-induced reactive arthritis that has lasted for more than 6 months
Detailed Description:
The initial infection that causes reactive arthritis is caused by one of two bacteria Chlamydia trachomatis which is usually acquired through sexual contact or Chlamydia pneumoniae which can cause respiratory infections Most people recover fully from the initial flare of arthritis symptoms However about 20 of people with reactive arthritis experience long-lasting symptoms In these individuals the Chlamydia bacteria exist in a persistent metabolically active state within the joint tissue even years after the initial exposure The bacteria produce heat shock proteins HSPs which are thought to play a key role in the chronic persistent state of Chlamydia and which may stimulate the immune inflammatory response seen in reactive arthritis This indicates the need for antimicrobial therapy that can reduce Chlamydias HSP production and block its metabolism The purpose of this study is to determine the effectiveness of long-term combination antibiotic therapy in treating people with chronic reactive arthritis The study will use two different combinations of common antibiotics doxycycline paired with rifampin and azithromycin paired with rifampin
This study will entail 6 months of treatment followed by 3 months of follow-up After screening eligible participants will be randomly assigned to one of three treatment groups rifampin once a day plus doxycycline twice a day rifampin once a day plus azithromycin once a day for 5 days then twice weekly or placebo Study visits will occur at baseline and Months 1 3 6 and 9 At all visits participants will undergo an interview a physical examination and blood collection They will also complete a questionnaire related to their symptoms and functional status At screening and Month 6 a synovial biopsy may be performed This will involve taking a sample of the tissue that lines the joints
This study will entail 6 months of treatment followed by 3 months of follow-up After screening eligible participants will be randomly assigned to one of three treatment groups rifampin once a day plus doxycycline twice a day rifampin once a day plus azithromycin once a day for 5 days then twice weekly or placebo Study visits will occur at baseline and Months 1 3 6 and 9 At all visits participants will undergo an interview a physical examination and blood collection They will also complete a questionnaire related to their symptoms and functional status At screening and Month 6 a synovial biopsy may be performed This will involve taking a sample of the tissue that lines the joints
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21AR053646-01 | NIH | None | httpsreporternihgovquickSearch1R21AR053646-01 |
| R21AR053646 | NIH | None | None |