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Combination Antibiotic Treatment for Reactive Arthritis Caused by Chlamydia Bacteria

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ClinicalTrials.gov Identifier: NCT00351273
Recruitment Status : Completed
First Posted : July 12, 2006
Results First Posted : August 10, 2016
Last Update Posted : November 12, 2018
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
University of South Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Arthritis, Reactive
Reiter Disease
Interventions Drug: Doxycycline and Rifampin
Drug: Azithromycin and Rifampin
Drug: Placebo
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Azithromycin & Rifampin Doxycycline & Rifampin Placebo
Hide Arm/Group Description Participants will receive Azithromycin and Rifampin Participants will receive Doxycycline and Rifampin Participants will receive placebo
Period Title: Overall Study
Started 15 12 15
Completed 14 10 10
Not Completed 1 2 5
Reason Not Completed
Lost to Follow-up             1             2             5
Arm/Group Title Azithromycin & Rifampin Doxycycline & Rifampin Placebo Total
Hide Arm/Group Description Participants will receive Azithromycin and Rifampin Participants will receive Doxycycline and Rifampin Participants will receive placebo Total of all reporting groups
Overall Number of Baseline Participants 15 12 15 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 12 participants 15 participants 42 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
12
 100.0%
13
  86.7%
40
  95.2%
>=65 years
0
   0.0%
0
   0.0%
2
  13.3%
2
   4.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 12 participants 15 participants 42 participants
44.5  (12) 43.8  (12.3) 49  (16.3) 45.8  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 12 participants 15 participants 42 participants
Female
7
  46.7%
5
  41.7%
6
  40.0%
18
  42.9%
Male
8
  53.3%
7
  58.3%
9
  60.0%
24
  57.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 12 participants 15 participants 42 participants
United States 15 12 14 41
Canada 0 0 1 1
1.Primary Outcome
Title Investigate Whether a 6 Month Course of Combined Antibiotics Was Effective Treatment.
Hide Description The outcome measure was a composite endpoint. Participants had to meet 4/6 clinical criteria. 17/24 subjects randomized to combination antibiotics did respond to treatment when compared to 3/10 randomized to placebo.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy and safety analyses were performed on an intent to treat(ITT) basis. Subjects who prematurely withdrew or who were lose to follow up for any reason were included in the ITT population and were considered nonresponders.
Arm/Group Title Azithromycin & Rifampin Doxycycline & Rifampin Placebo
Hide Arm/Group Description:
Participants will receive Azithromycin and Rifampin
Participants will receive Doxycycline and Rifampin
Participants will receive placebo
Overall Number of Participants Analyzed 14 10 10
Measure Type: Number
Unit of Measure: participants
10 7 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin & Rifampin, Doxycycline & Rifampin, Placebo
Comments Difference in the percentages of participants with response between all those who received combination therapy vs. placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 40.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Patients With a Complete Response (Resolution of All Symptoms)
Hide Description Patients who completed full 6 months of treatment that reported feeling complete resolution of symptoms at month 6 visit and had no worsening of condition at the month 9 follow up visit.
Time Frame Months 6 and 9
Hide Outcome Measure Data
Hide Analysis Population Description
Patients randomized to combination antibiotics who believed that their disease went into complete remission during the trial
Arm/Group Title Azithromycin and Rifampin Doxycycline and Rifampin Received Placebo
Hide Arm/Group Description:

Participants received Azithromycin and Rifampin

Azithromycin and Rifampin: Azithromycin 500mg daily for 5 days and then twice weekly; Rifampin 300mg daily (both for 6 months)

Participants received Doxycycline and Rifampin

Doxycycline and Rifampin: doxycycline 100mg daily; rifampin 300mg daily (both for 6 months)

Participants received placebo

Placebo: Methylcellulose

Overall Number of Participants Analyzed 10 7 3
Measure Type: Count of Participants
Unit of Measure: Participants
5
  50.0%
1
  14.3%
0
   0.0%
3.Secondary Outcome
Title Erythrocyte Sedimentation Rate (ESR)
Hide Description Comparison of mean ESR rates of combination antibiotic group vs placebo group at Baseline, Month 1, 3, 6 and 9
Time Frame Baseline Month 1, 3, 6 and 9
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Antibiotic Placebo
Hide Arm/Group Description:
Group who recieved either combination of antibiotics
Group who recieved placebo
Overall Number of Participants Analyzed 27 15
Mean (Full Range)
Unit of Measure: millimeters/hour
Baseline
25.1
(1 to 81)
18.9
(1 to 74)
Month 1
17.8
(2 to 50)
25.2
(1 to 78)
Month 3
17.7
(1 to 72)
19.8
(4 to 42)
Month 6
12.7
(1 to 55)
17.0
(3 to 37)
Month 9
14.0
(1 to 47)
18.4
(4 to 45)
4.Secondary Outcome
Title hsCRP
Hide Description Comparison of high sensitivity C-reactive protein measurement in combination antibiotic group vs placebo group at Baseline, Month 1, 3, and 6
Time Frame Baseline, Month 1, 3, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Antibiotic Placebo
Hide Arm/Group Description:
Group who recieved either combination of antibiotics
Group who recieved placebo
Overall Number of Participants Analyzed 27 15
Mean (Full Range)
Unit of Measure: mg/litre
Baseline
1.07
(0.02 to 10.9)
0.42
(0.069 to 1.85)
Month 1
0.56
(0.02 to 3.65)
0.27
(0.106 to 0.651)
Month 3
0.63
(0.02 to 5.88)
0.55
(0.035 to 2.51)
Month 6
0.41
(0.02 to 2.34)
0.34
(0.02 to 0.796)
5.Secondary Outcome
Title HAQ DI Score
Hide Description

Comparison of HAQ-DI score of combination antibiotic group vs placebo group at Baseline, Month 1,3,6 and 9 The Health assessment questionnaire disability index (HAQ-DI) is a questionnaire for the assessment of Rheumatoid Arthritis. The questionnaire is a patient reported outcome (PRO) which is usually self-administered by the patient There are 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. In addition, if an aide or device is used or if help is required from another individual, then the minimum score for that section is 2. If the section score is already 2 or more then no modification is made.

The 8 scores of the 8 sections are summed and divided

Time Frame Baseline, Month 1,3,6 and 9
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Antibiotic Placebo
Hide Arm/Group Description:
Group who recieved either combination of antibiotics
Group who recieved placebo
Overall Number of Participants Analyzed 27 15
Mean (Full Range)
Unit of Measure: score on a scale
Baseline
0.84
(0 to 3)
1.1
(0 to 3)
Month 1
0.79
(0 to 3)
0.92
(0 to 3)
Month 3
0.68
(0 to 3)
0.87
(0 to 3)
Month 6
0.71
(0 to 3)
0.99
(0 to 3)
Month 9
0.57
(0 to 3)
0.92
(0 to 3)
6.Secondary Outcome
Title PhGA Assessment
Hide Description Comparison of Physician's global assessment of disease activity (PhGA) using 0-100mm visual analog scale (VAS) , where 0 indicates the best possible outcome and 100 indicates the worst possible outcome, in combination antibiotic vs placebo groups at Baseline, month 1,3,6 and 9
Time Frame Baseline, month 1,3,6 and 9
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Antibiotic Placebo
Hide Arm/Group Description:
Group who recieved either combination of antibiotics
Group who recieved placebo
Overall Number of Participants Analyzed 27 15
Mean (Full Range)
Unit of Measure: units on a scale
Baseline
63.9
(44 to 91)
60.2
(3 to 85)
Month 1
35.2
(2 to 70)
52.9
(24 to 77)
Month 3
23.2
(0 to 51)
49.4
(5 to 74)
Month 6
16.3
(0 to 49)
45.7
(0 to 72)
Month 9
17.7
(0 to 50)
43.8
(2 to 72)
7.Secondary Outcome
Title Swollen 76 Joint Count (SJC)
Hide Description Comparison of modified Swollen Joint Counts between combination antibiotic and placebo groups at Baseline, Month 1, 3, 6 and 9. Determination of swelling in each of the 76 joints was determined by any swelling or absence of swelling. Each swollen joint receives a value of 1, ranging from 0-76 as a possible score.
Time Frame Baseline, month 1,3,6 and 9
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Antibiotic Placebo
Hide Arm/Group Description:
Group who recieved either combination of antibiotics
Group who recieved placebo
Overall Number of Participants Analyzed 27 15
Mean (Full Range)
Unit of Measure: Swollen Joints
Baseline
4.1
(0 to 12)
4.5
(0 to 9)
Month 1
1.7
(0 to 6)
3.5
(0 to 8)
Month 3
0.9
(0 to 4)
4.3
(0 to 13)
Month 6
0.9
(0 to 5)
5.2
(0 to 13)
Month 9
0.5
(0 to 4)
5.1
(0 to 12)
8.Secondary Outcome
Title 78 Tender Joint Count (TJC)
Hide Description Comparison of modified 78 Tender Joint Count (TJC) between combination antibiotic and placebo groups at Baseline, Month 1, 3, 6 and 9. Determination of tender joing in each of the 78 joints was determined by examination. Each tender joint receives a value of 1, ranging from 0-78 as a possible score.
Time Frame Baseline, Month 1, 3, 6 and 9
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Antibiotic Placebo
Hide Arm/Group Description:
Group who recieved either combination of antibiotics
Group who recieved placebo
Overall Number of Participants Analyzed 27 15
Mean (Full Range)
Unit of Measure: Tender Joints
Baseline
7.4
(1 to 20)
9.6
(0 to 24)
Month 1
5.0
(0 to 23)
10.6
(0 to 25)
Month 3
3.3
(0 to 17)
10.8
(0 to 28)
Month 6
2.0
(0 to 9)
11.8
(0 to 37)
Month 9
1.9
(0 to 9)
10.9
(0 to 29)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Azithromycin & Rifampin Doxycycline & Rifampin Placebo
Hide Arm/Group Description Participants will receive Azithromycin and Rifampin Participants will receive Doxycycline and Rifampin Participants will receive placebo
All-Cause Mortality
Azithromycin & Rifampin Doxycycline & Rifampin Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Azithromycin & Rifampin Doxycycline & Rifampin Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/12 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Azithromycin & Rifampin Doxycycline & Rifampin Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/12 (0.00%)   0/15 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: John D. Carter, M.D.
Organization: University of South Florida
Phone: (813) 974-2681
Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00351273     History of Changes
Other Study ID Numbers: R21AR053646 ( U.S. NIH Grant/Contract )
R21AR053646 ( U.S. NIH Grant/Contract )
1R21AR053646-01 ( U.S. NIH Grant/Contract )
First Submitted: July 10, 2006
First Posted: July 12, 2006
Results First Submitted: August 5, 2009
Results First Posted: August 10, 2016
Last Update Posted: November 12, 2018