| CTRI Number |
CTRI/2024/07/071014 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare the effects of two drugs, Ceftriaxone and Benzathine Penicillin in the treatment of Early stage of the sexually transmitted disease, Syphilis |
|
Scientific Title of Study
|
A comparative study of Injection Benzathine Penicillin and Injection Ceftriaxone in the management of Early Syphilis |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Briswin Jino B G |
| Designation |
Junior Resident |
| Affiliation |
Government Tirunelveli Medical College |
| Address |
Department of Dermatology, Venereology and Leprosy,
Government Tirunelveli Medical College Hospital,
Tirunelveli.
Tirunelveli
TAMIL NADU
627011
India |
| Phone |
9489857660 |
| Fax |
|
| Email |
jino.jinobj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. M. Selvakumar |
| Designation |
Associate Professor |
| Affiliation |
Government Tirunelveli Medical College |
| Address |
Department of Dermatology, Venereology and Leprosy,
Government Tirunelveli Medical College Hospital,
Tirunelveli.
Department of Dermatology, Venereology and Leprosy,
Government Tirunelveli Medical College Hospital,
Tirunelveli.
Tirunelveli
TAMIL NADU
627011
India |
| Phone |
9894308296 |
| Fax |
|
| Email |
drmselvakumar71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Briswin Jino B G |
| Designation |
Junior Resident |
| Affiliation |
Government Tirunelveli Medical College |
| Address |
Department of Dermatology, Venereology and Leprosy,
Government Tirunelveli Medical College Hospital,
Tirunelveli.
TAMIL NADU
627011
India |
| Phone |
9489857660 |
| Fax |
|
| Email |
jino.jinobj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology, Venereology and Leprosy, Government Tirunelveli Medical College, Tirunelveli - 627011,
Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Government Tirunelveli Medical College |
| Address |
Department of Dermatology, Venereology and Leprosy,
Government Tirunelveli Medical college Hospital,
Tirunelveli - 627011 |
| Type of Sponsor |
Government medical college |
|
|
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 Briswin Jino BG |
Government Tirunelveli Medical College |
Room No 41, Venereology OPD, Department of Dermatology, Venereology and Leprosy
Tirunelveli
TAMIL NADU |
9489857660
jino.jinobj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Scientific Advisory Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A519||Early syphilis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Benzathine Penicillin |
Single Dose of Injection Benzathine Penicillin 2.4 Million Units deep Intramuscularly |
| Intervention |
Injection Ceftriaxone |
Injection Ceftriaxone 1 gram Intravenously for 10 days |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients who present in STD Clinics with untreated Early syphilis (Includes Primary, Secondary and Early latent syphilis).
Operational definition for Early syphilis – 1 year from the primary lesion(chancre) or if there is no primary chancre 1 year from the date of last contact with REACTIVE RPR & Confirmed by POSITIVE TPHA
|
|
| ExclusionCriteria |
| Details |
1. Positive skin-test reaction to penicillin antigen and ceftriaxone antigen
2. History of penicillin and ceftriaxone allergy
3. Patients who have received any other antibiotics before initiation of treatment
4. Patients with Late latent syphilis and Tertiary syphilis
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serological response as defined as a four fold decrease in the initial RPR titre within 6 months of treatment |
Serological response as defined as a four fold decrease in the initial RPR titre within 6 months of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing the time taken for RPR to fall in both groups and to monitor for Adverse events if any in both groups |
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/07/2024 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized controlled trial which aims at comparing the efficacy Injection Benzathine Penicillin and Injection Ceftriaxone in the management of Early syphilis. Several studies have shown the efficacy of Injection Ceftriaxone in the management of Neurosyphilis and Primary and secondary syphilis in special populations like those infected with HIV and pregnant women. But there are limited studies available supporting Injection ceftriaxone as an alternative treatment for Early syphilis without HIV infection. The outcome will be measured by the fourfold decline in RPR titre from the baseline. Patients who have treatment failure with Injection Ceftriaxone will be given the standard dose of Injection Benzathine Penicillin. |