The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis

• ClinicalTrials.gov Identifier: NCT01178762
• Recruitment Status: Completed
• First Posted: August 10, 2010
• Results First Posted: October 27, 2010
• Last Update Posted: October 27, 2010
• Sponsor: National Taiwan University Hospital
• Information provided by: National Taiwan University Hospital

Study Description

Brief Summary:

Chlamydia trachomatis is one of the major causes of sexually transmitted disease and also the leading infectious cause of blindness in the world.Treatment of C. trachomatis eye infection has involved for a long time. The efficacy of single dose azithromycin has already been demonstrated as effective in the treatment of both trachoma and adult inclusion conjunctivitis.However, in our clinical experience, some patients of chlamydial conjunctivitis may require augmented single dose azithromycin treatments before C. trachomatis is eradicated. In this way, we would like to known the efficacy of single dose and augmented single dose azithromycin in the treatment of chlamydial conjunctivitis.

Condition or disease	Intervention/treatment	Phase
Chlamydial Conjunctivitis	Drug: Azithromycin	Not Applicable

Detailed Description:

Medical records of patients with clinically suspected chlamydial conjunctivitis between January 1, 2006 and December 31, 2006 at one cornea specialist's (Y.C.H) out-patient clinic were retrospectively reviewed. At this clinic, patients of both sexes with acute, chronic or recurrent follicular conjunctivitis with the symptoms and signs of chlamydial conjunctivitis suspected were tested for Chlamydia direct fluorescent antibody (DFA) tests and arranged for next time out-patient clinic follow up 1-2 weeks later. The patients who attended the follow up visit with positive DFA results were treated with oral azithromycin. These patients received a single dose oral azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks. Repeated DFA examinations were performed 4 to 6 weeks later. If the DFA examinations still showed positive results, augmented single dose oral azithromycin once a week for one week was given again till the DFA showed negative results. The occurrence and frequency of adverse events recorded in the medical charts were reviewed as well.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis
• Study Start Date: September 2007
• Actual Primary Completion Date: November 2007
• Actual Study Completion Date: December 2007

Arms and Interventions

Arm	Intervention/treatment
Experimental: Observation	Drug: Azithromycin; Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis; Other Name: zithromax(Pfizer)

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   We performed direct fluorescent antibody (DFA) tests for Chlamydia by swabbing across the lower and upper tarsal conjunctiva four times after topical application of 0.5% proparacaine. All of the DFA tests were examined by the same experienced microbiologist who was masked to the identities and clinical conditions of the patients. Each DFA slide was read under a fluorescent microscope and was observed for discrete fluorescent chlamydial elementary bodies (EBs).The DFA test was considered positive if above 10 EBs were counted per high-power field.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients of clinically chlamydial conjunctivitis suspected and proven by direct fluorescent antibody(DFA)results

Exclusion Criteria:

• Patients with pregnancy or lactation, history of allergy to macrolides, evidence or history of hepatic, renal, hematological or cardiovascular disease

Contacts and Locations

Locations

Taiwan

National Taiwan University Hospital

Taipei, Taiwan, 100

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

• Study Director: Yu-Chih Hou, MD; National Taiwan University Hospital
• Study Director: Fung-Rong Hu, MD; National Taiwan University Hospital
• Principal Investigator: Yan-Ming Chen, MD; National Taiwan University Hospital

More Information

Additional Information:

Publication provided 

• Responsible Party: Yan-Ming Chen / Yu-Chih Hou, National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT01178762
• Other Study ID Numbers: 200709013R
• First Posted: August 10, 2010
• Results First Posted: October 27, 2010
• Last Update Posted: October 27, 2010
• Last Verified: September 2010

Keywords provided by National Taiwan University Hospital:

Oral Azithromycin; Chlamydial Conjunctivitis

Additional relevant MeSH terms:

Conjunctivitis, Inclusion; Trachoma; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Conjunctivitis, Bacterial; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chlamydia Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Eye Infections; Corneal Diseases; Azithromycin; Anti-Bacterial Agents; Anti-Infective Agents