The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis

NCT01178762 | Completed Results DMC

• 1 other identifier: 200709013R
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Chlamydial Conjunctivitis

Keywords

Oral Azithromycin; Chlamydial Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• Total Number of Participants With Negative Chlamydia Direct Fluorescent Antibody (DFA) Test Results After Oral Azithromycin Treatments

  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.

  4 weeks, 8 weeks and 12 weeks after the first dose of the medication

Study Arms (1)

Observation

EXPERIMENTAL

Drug: Azithromycin

Interventions

Azithromycin DRUG

Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis

Also known as: zithromax(Pfizer)

Observation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Links

• Publication provided

MeSH Terms

Conditions

Conjunctivitis, Inclusion

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Conjunctivitis, Bacterial; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chlamydia Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Yan-Ming Chen / Yu-Chih Hou
• Organization: National Taiwan University Hospital

louice1070@gmail.com

886-2-2312-3456

Study Officials

• Yu-Chih Hou, MD

  National Taiwan University Hospital

  STUDY DIRECTOR

• Fung-Rong Hu, MD

  National Taiwan University Hospital

  STUDY DIRECTOR

• Yan-Ming Chen, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 31, 2008
• First Posted: August 10, 2010
• Study Start: September 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: December 1, 2007
• Last Updated: October 27, 2010
• Results First Posted: October 27, 2010

Record last verified: 2010-09

Locations

TW (1)