Chlamydial Conjunctivitis
Conditions
Keywords
Oral Azithromycin, Chlamydial Conjunctivitis
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.
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.
Interventions
DRUGAzithromycin
Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis
Sponsors
National Taiwan University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Participants With Negative Chlamydia Direct Fluorescent Antibody (DFA) Test Results After Oral Azithromycin Treatments | 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. |
Countries
Taiwan
Participant flow
Recruitment details
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
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 .
Participants by arm
| Arm | Count |
|---|---|
| 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. | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 15 |
Baseline characteristics
| Characteristic | Azithromycin |
|---|---|
| Age, Categorical <=18 years | 6 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Age Continuous | 41 years STANDARD_DEVIATION 12 |
| Region of Enrollment Taiwan | 42 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
Primary
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.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azithromycin | Total Number of Participants With Negative Chlamydia Direct Fluorescent Antibody (DFA) Test Results After Oral Azithromycin Treatments | 27 participants |