Trial Outcomes & Findings for The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis (NCT NCT01178762)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

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

Results posted on

2010-10-27

Participant Flow

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

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 .

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	42
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	15

Baseline Characteristics

The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Azithromycin n=42 Participants 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.
Age, Categorical <=18 years	6 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age Continuous	41 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Region of Enrollment Taiwan	42 participants n=5 Participants

PRIMARY outcome

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

Population: Only participants with confirmed DFA tests are counted in the results below. Participants with confirmed negative DFA tests subsequently stopped treatment and were not retested. Participants lost to follow-up are counted as not having a confirmed DFA negative test

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.

Outcome measures

Outcome measures
Measure	Azithromycin n=42 Participants 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.
Total Number of Participants With Negative Chlamydia Direct Fluorescent Antibody (DFA) Test Results After Oral Azithromycin Treatments	27 participants

Adverse Events

Azithromycin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yan-Ming Chen / Yu-Chih Hou

National Taiwan University Hospital

Phone: 886-2-2312-3456

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place