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Treatment Failure of Chlamydial Infection in Males and Females in Youth Correctional Facilities

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ClinicalTrials.gov Identifier: NCT00980148
Recruitment Status : Completed
First Posted : September 18, 2009
Results First Posted : March 18, 2015
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chlamydial Infection
Interventions Drug: Azithromycin
Drug: Doxycycline
Enrollment 567
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Azithromycin Arm Doxycycline Arm
Hide Arm/Group Description Azithromycin 1 gm oral single dose Doxycycline 100 mg oral twice a day for 7 days
Period Title: Overall Study
Started 284 283
Completed 155 [1] 155 [1]
Not Completed 129 128
Reason Not Completed
Discharged from facility             89             96
Received other antichlamydia treatment             20             14
Negative for chlamydia at enrollment             12             9
Various other reasons             8             9
[1]
Completed primary evaluation at study visit # 2 (day 28 after therapy started)
Arm/Group Title Azithromycin Arm Doxycycline Arm Total
Hide Arm/Group Description Azithromycin 1 gm oral single dose Doxycycline 100 mg oral twice a day for 7 days Total of all reporting groups
Overall Number of Baseline Participants 155 155 310
Hide Baseline Analysis Population Description
The per protocol population is comprised of participants who completed therapy and whose failure status could be established at the day 28 visit. Participants were considered to have completed therapy if they took a single dose of azithromycin or at least 10 of the 14 doses of doxycycline.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 155 participants 310 participants
<=18 years
155
 100.0%
154
  99.4%
309
  99.7%
Between 18 and 65 years
0
   0.0%
1
   0.6%
1
   0.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 155 participants 155 participants 310 participants
17.0  (0.9) 16.8  (1.1) 16.9  (1.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 155 participants 310 participants
Female
53
  34.2%
56
  36.1%
109
  35.2%
Male
102
  65.8%
99
  63.9%
201
  64.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 155 participants 155 participants 310 participants
155 155 310
1.Primary Outcome
Title Assess Microbiological Failure of Recommended Azithromycin and Doxycycline Regimens in Uncomplicated Chlamydia Trachomatis Infection in a Setting Where Repeat Exposure to Chlamydia-infected Persons Can be Minimized.
Hide Description The proportion of participants with testing by Gen-Probe Aptima Combo 2 that is positive for C. trachomatis and C. trachomatis OmpA (Major Outer Membrane Protein) genotyping reveals the baseline chlamydial strain and the repeat positive chlamydial strain to be the same genotype (i.e., concordant).
Time Frame Study visit # 2 (Day 28 after therapy started)
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol population is comprised of participants who completed therapy and whose failure status could be established at the day 28 visit. Participants were considered to have completed therapy if they took a single dose of azithromycin or at least 10 of the 14 doses of doxycycline.
Arm/Group Title Azithromycin Arm Doxycycline Arm
Hide Arm/Group Description:
Azithromycin 1 gm oral single dose
Doxycycline 100 mg oral twice a day for 7 days
Overall Number of Participants Analyzed 155 155
Measure Type: Number
Unit of Measure: percentage of participants
3.2 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin Arm, Doxycycline Arm
Comments This noninferiority study tested the null hypothesis that the failure rate of azithromycin is 5% higher than that of doxycycline against the alternative hypothesis that there is no difference between the two treatments. The one-sided 90% exact confidence interval was used to estimate the difference between the two failures rates.
Type of Statistical Test Non-Inferiority or Equivalence
Comments This noninferiority study tested the null hypothesis that the failure rate of azithromycin is 5% higher than that of doxycycline against the alternative hypothesis that there is no difference between the two treatments. The treatment failure rate was assumed to be 3% for both treatments. To test this hypothesis at the one-sided 0.10 significance level with power of 0.90 required 153 study subjects per arm in the per-protocol population.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.2
Confidence Interval (1-Sided) 90%
5.9
Estimation Comments The risk difference is the percentage in the azithromycin arm with treatment failure minus the percentage in the doxycycline arm with treatment failure. Noninferiority of azithromycin would be supported if the upper 90% confidence limit is below 5%.
2.Secondary Outcome
Title Demographical Characteristics and Clinical Parameters to Predict Treatment Outcome.
Hide Description [Not Specified]
Time Frame Baseline and study visit #2 (Day 28 after therapy is started)
Outcome Measure Data Not Reported
Time Frame Adverse events (AEs) that occur after study drug administration (Study Visit 1) and through the first follow-up visit (Study Visit 2, Day 28) were recorded. AEs were followed until resolution even if this extended beyond the study-reporting period.
Adverse Event Reporting Description Resolution of an AE is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic. In Sept 2010, the protocol was amended to streamline reportable AE’s by limiting to GI related symptoms, vaginal irritation or itching, and dermatologic reactions.
 
Arm/Group Title Azithromycin Arm Doxycycline Arm
Hide Arm/Group Description Azithromycin 1 gm oral single dose Doxycycline 100 mg oral twice a day for 7 days
All-Cause Mortality
Azithromycin Arm Doxycycline Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Azithromycin Arm Doxycycline Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/155 (0.00%)      0/155 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Azithromycin Arm Doxycycline Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/155 (7.10%)      18/155 (11.61%)    
Gastrointestinal disorders     
Abdominal Pain * 1  6/155 (3.87%)  7 10/155 (6.45%)  10
Vomiting * 1  6/155 (3.87%)  6 10/155 (6.45%)  11
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
The analysis of the secondary endpoint Demographical Characteristics and Clinical Parameters to Predict Treatment Outcome was limited by the small number of events and is not presented.
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
Layout table for Results Point of Contact information
Name/Title: Shelly Lensing, Statistician
Organization: University of Arkansas for Medical Sciences
Phone: 501-686-8203
EMail: sylensing@uams.edu
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00980148     History of Changes
Other Study ID Numbers: 07-0012
First Submitted: September 17, 2009
First Posted: September 18, 2009
Results First Submitted: March 5, 2015
Results First Posted: March 18, 2015
Last Update Posted: March 18, 2015