| CTRI Number |
CTRI/2023/03/050657 [Registered on: 14/03/2023] Trial Registered Prospectively |
| Last Modified On: |
10/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Isolation, Characterisation and Antimicrobial susceptibility pattern of Neisseria gonorrhoea |
|
Scientific Title of Study
|
Isolation, Characterisation and Antimicrobial Susceptibility Patterns of Neisseria gonorrhoeae from Patients Attending Sexually Transmitted Infections Clinic |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surya VL |
| Designation |
Postgraduate |
| Affiliation |
Government Coimbatore Medical College and Hospital, Coimbatore |
| Address |
Department of Microbiology, Government Coimbatore Medical College and Hospital, Coimbatore, Tamil Nadu
Coimbatore
TAMIL NADU
641004
India |
| Phone |
8098212475 |
| Fax |
|
| Email |
suryaveeramani92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mythily N |
| Designation |
Professor and Head |
| Affiliation |
Government Coimbatore Medical College and Hospital, Coimbatore |
| Address |
Department of Microbiology, Government Coimbatore Medical College and Hospital, Coimbatore, Tamil Nadu
Coimbatore
TAMIL NADU
641004
India |
| Phone |
8098212475 |
| Fax |
|
| Email |
kumar.mohan324@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surya VL |
| Designation |
Postgraduate |
| Affiliation |
Government Coimbatore Medical College and Hospital, Coimbatore |
| Address |
Department of Microbiology, Government Coimbatore Medical College and Hospital, Coimbatore, Tamil Nadu
Coimbatore
TAMIL NADU
641004
India |
| Phone |
8098212475 |
| Fax |
|
| Email |
suryaveeramani92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Coimbatore Medical College and Hospital, Coimbatore |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Surya VL |
Government Coimbatore Medical College and Hospital |
Room number 108, Microbiology diagnostic lab, Government Coimbatore Medical College and Hospital, Trichy road, Coimbatore, Tamil Nadu. Pin – 641014
Coimbatore
TAMIL NADU |
8098212475
suryaveeramani92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee, Government Coimbatore Medical College, Coimbatore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A549||Gonococcal infection, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
Patients less than 15 years of age
Patients not providing informed written consent to participate in the study
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of gonococcal and non-gonococcal infections
Proportion of cultures positive for growth
Proportion of gonococcal infections sensitive, intermediate, and resistant to antimicrobials |
Cross-sectional (only at the time of sample collection or baseline) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The information obtained in the study may aid in formulating new antimicrobial policy in the tertiary care hospital |
Single time point |
|
|
Target Sample Size
|
Total Sample Size="206"
Sample Size from India="206"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/04/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The sexually transmitted infections (STI) have a profound
impact on sexual and reproductive health worldwide. It has been estimated that
more than one million STIs are acquired every day. Gonorrhoea is particularly
common in low- and middle-income countries like India. Multiple studies
document the prevalence of gonorrhoea in India to be between 0.2% to 14.1%.
The antimicrobial resistance (AMR) for gonorrhoea has
increased rapidly in recent years and has reduced treatment options. The
Gonococcal AMR Surveillance Programme (GASP) has shown high rates of resistance
to many antibiotics including quinolone, azithromycin, and extended-spectrum
cephalosporins, a last-line treatment. In 2018, 66 countries in six WHO regions
reported data on antimicrobial resistance to World Health Organizations’ GASP. The
results showed that half (50%) of the countries had more than or equal to 100
gonococcal 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. To
identify and isolate Gonococcus (Neisseria gonorrhoea) among patients attending
STI/RTI clinic in a tertiary care hospital, Coimbatore district, Tamil Nadu
2. To assess
the antimicrobial susceptibility pattern of gonococcal isolates
3. To
determine the association between antimicrobial susceptibility pattern and independent
variables considered in the study. |