Combination Antibiotic Treatment for Reactive Arthritis Caused by Chlamydia Bacteria
Condition: Arthritis, Reactive; Reiter Disease
MeSH terms: Chlamydia Infections; Arthritis, Reactive; Arthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      Reactive arthritis, also known as Reiter's 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 Chlamydia's 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.
    

Intervention name(s): Doxycycline and Rifampin; Azithromycin and Rifampin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): doxycycline 100mg daily; rifampin 300mg daily (both for 6 months); Azithromycin 500mg daily for 5 days and then twice weekly; Rifampin 300mg daily (both for 6 months); Methylcellulose
Other intervention name(s): Atridox and Rifadin; Zithromax and Rifadin; Placebo effect
Intervention MeSH terms: Azithromycin; Doxycycline; Rifampin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chlamydia