Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01178762
First received: August 31, 2008
Last updated: October 5, 2010
Last verified: September 2010
Results First Received: August 12, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chlamydial Conjunctivitis
Intervention: Drug: Azithromycin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with clinically suspected chlamydial conjunctivitis at the outpatient clinic of Dr Hou at National Taiwan University Hospital (NTUH) between 1 January 2006 and 31 December 2006 were included

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with symptoms and signs of chlamydial conjunctivitis suspected were tested for Chlamydia direct fluorescent antibody tests. The patients with positive results were treated with oral azithromycin,except those who were pregnant, lactating,with a history of allergy to macrolides or hepatic, renal,hematological or cardiovascular disease .

Reporting Groups
  Description
Azithromycin DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.

Participant Flow:   Overall Study
    Azithromycin
STARTED   42 
COMPLETED   27 
NOT COMPLETED   15 
Lost to Follow-up                15 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Azithromycin DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.

Baseline Measures
   Azithromycin 
Overall Participants Analyzed 
[Units: Participants]
 42 
Age 
[Units: Participants]
 
<=18 years   6 
Between 18 and 65 years   28 
>=65 years   8 
Age 
[Units: Years]
Mean (Standard Deviation)
 41  (12) 
Gender 
[Units: Participants]
 
Female   18 
Male   24 
Region of Enrollment 
[Units: Participants]
 
Taiwan   42 


  Outcome Measures

1.  Primary:   Total Number of Participants With Negative Chlamydia Direct Fluorescent Antibody (DFA) Test Results After Oral Azithromycin Treatments   [ Time Frame: 4 weeks, 8 weeks and 12 weeks after the first dose of the medication ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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: Yan-Ming Chen / Yu-Chih Hou
Organization: National Taiwan University Hospital
phone: 886-2-2312-3456 ext 62131
e-mail: louice1070@gmail.com



Responsible Party: Yan-Ming Chen / Yu-Chih Hou, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01178762     History of Changes
Other Study ID Numbers: 200709013R
Study First Received: August 31, 2008
Results First Received: August 12, 2010
Last Updated: October 5, 2010
Health Authority: Taiwan: Department of Health