The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis - Study Results

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

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.

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

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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.

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
Number of Participants [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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

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
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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

No publications provided

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