Isolation, Characterisation and Antimicrobial susceptibility pattern of Neisseria gonorrhoea

Not yet recruiting

• Conditions: Gonococcal infection, unspecified,

• Registration Number: CTRI/2023/03/050657

Brief Summary

The sexually transmitted infections (STI) have a profoundimpact on sexual and reproductive health worldwide. It has been estimated thatmore than one million STIs are acquired every day. Gonorrhoea is particularlycommon in low- and middle-income countries like India. Multiple studiesdocument the prevalence of gonorrhoea in India to be between 0.2% to 14.1%.

The antimicrobial resistance (AMR) for gonorrhoea hasincreased rapidly in recent years and has reduced treatment options. TheGonococcal AMR Surveillance Programme (GASP) has shown high rates of resistanceto many antibiotics including quinolone, azithromycin, and extended-spectrumcephalosporins, a last-line treatment. In 2018, 66 countries in six WHO regionsreported data on antimicrobial resistance to World Health Organizations’ GASP. Theresults showed that half (50%) of the countries had more than or equal to 100gonococcal isolates resistant for at least one antibiotic. Other findings were 10.8%countries reported more than 5% of specimens with extended-spectrum cephalosporin resistance;69.0% countries reported more than 5% azithromycin resistance; and 96.9%countries reported more than 5% ciprofloxacin resistance. Hence the study.

The objectives of the study are as follows,

1.     Toidentify and isolate Gonococcus (Neisseria gonorrhoea) among patients attendingSTI/RTI clinic in a tertiary care hospital, Coimbatore district, Tamil Nadu

2.     To assessthe antimicrobial susceptibility pattern of gonococcal isolates

3.     Todetermine the association between antimicrobial susceptibility pattern and independentvariables considered in the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-04
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

• Males presenting with urethritis [A male presenting with urethral discharge (purulent, containing mucopus); swollen and/or painful testicles with or without genital itching; burning or pain during urination with or without increased frequency; infection of the epididymis (coiled tube leading from the testis to the spermatic cord); urethral abscess or narrowing (stricture)].
• Females presenting with complains of vaginal/cervical discharge (purulent, containing mucopus), urethral discharge, burning or pain during micturition (dysuria, may have red and tender (inflamed) urethra), lower abdominal pain (pain below the belly button; pelvic pain), infertility, and dyspareunia and/or bleeding after intercourse.
• Patients providing informed written consent to participate in the study.

Exclusion Criteria

Patients less than 15 years of age Patients not providing informed written consent to participate in the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of gonococcal and non-gonococcal infections	Cross-sectional (only at the time of sample collection or baseline)
Proportion of cultures positive for growth	Cross-sectional (only at the time of sample collection or baseline)
Proportion of gonococcal infections sensitive, intermediate, and resistant to antimicrobials	Cross-sectional (only at the time of sample collection or baseline)

Secondary Outcome Measures

Name	Time	Method
The information obtained in the study may aid in formulating new antimicrobial policy in the tertiary care hospital	Single time point

Trial Locations

Locations (1)

Government Coimbatore Medical College and Hospital; 🇮🇳 Coimbatore, TAMIL NADU, India

Government Coimbatore Medical College and Hospital

🇮🇳Coimbatore, TAMIL NADU, India

Dr Surya VL

Principal investigator

8098212475

suryaveeramani92@gmail.com