Efficacy of single dose azithromycin in the treatment of non-gonococcal urethritis in homosexual vs heterosexual men.
Not Applicable
- Conditions
- Health Condition 1: A64- Unspecified sexually transmitted disease
- Registration Number
- CTRI/2020/12/029666
- Lead Sponsor
- All India Institute of Medical Sciences New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Age more than 18 years
2.Giving consent for examination and collection of urethral swabs and first void urine for microscopy, culture and or molecular methods.
Exclusion Criteria
1.Gonococcal urethritis diagnosed as either presence of intracellular gram negative diplococci on Gram stain and or culture positivity for N. gonorrhea.
2.Presence of other sexually transmitted infections requiring another kit regimen apart from urethral discharge (kit 1) i.e. genital ulcer disease herpetic, genital ulcer disease non- herpetic, inguinal bubo.
3.Received oral antibiotics in past 15 days.
4.Patient with contraindication to receiving either cefixime or azithromycin.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of cases with clinical cure based on history, examination and bed side tests at 3 weeks follow up in the two groups. <br/ ><br>Timepoint: 3 weeks
- Secondary Outcome Measures
Name Time Method Prevalence, clinical and microbiological cure rates at extra-urethral sites such as ano-rectum and oro-pharnyx, depending on the history of sexual exposure at these sites in the two groups will also be compared at 3 weeks follow up. <br/ ><br>Timepoint: 3 weeks <br/ ><br>;Proportion of cases with clinical cure based on history, examination and bed side tests at 1 week follow up in the two groups. <br/ ><br>Timepoint: 1 week;proportion of cases with microbiological cure in the two groups. It will be calculated overall and as well as individually for each agent (Chlamydia trachomatis, Mycoplasma genitalium and Ureaplasma urealyticum) at 3 weeks follow up. <br/ ><br>Timepoint: 3 weeks;Time taken for resolution of symptoms, which will be determined from the history given by the patient based on the daily log. The first day of the symptom resolution for 5 consecutive days. It will be compared between the two groups thereafter. <br/ ><br>Timepoint: 3 weeks