| CTRI Number |
CTRI/2023/01/048871 [Registered on: 10/01/2023] Trial Registered Prospectively |
| Last Modified On: |
03/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of treatment failure, relapse or recurrent Bacterial vaginosis infection |
|
Scientific Title of Study
|
Evaluating the inflammatory, microbiome profile and co-infections in women diagnosed with treatment failure, relapse or recurrent Bacterial vaginosis -A Prospective analytic study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepti Tandon |
| Designation |
Scientist b |
| Affiliation |
ICMR NIRRCH |
| Address |
Department of Clinical Research
ICMR- National Institute for Research in Reproductive Health (NIRRH)
J.M. Street, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224192030 |
| Fax |
|
| Email |
gdeepti167@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepti Tandon |
| Designation |
Scientist b |
| Affiliation |
ICMR NIRRCH |
| Address |
Department of Clinical Research
ICMR- National Institute for Research in Reproductive Health (NIRRH)
J.M. Street, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224192030 |
| Fax |
|
| Email |
gdeepti167@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepti Tandon |
| Designation |
Scientist b |
| Affiliation |
ICMR NIRRCH |
| Address |
Department of Clinical Research
ICMR- National Institute for Research in Reproductive Health (NIRRH)
J.M. Street, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224192030 |
| Fax |
|
| Email |
gdeepti167@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ICMR Extramural grant |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Niranjan Mayadeo |
KEM HOSPITAL Mumbai |
Department of obstetric & Gynecology
Acharya Donde Marg, Parel,
Mumbai 400 012. India
Mumbai
MAHARASHTRA |
9869233317
drmayadeo@gmail.com |
| Dr Deepti Tandon |
National institute for research in reproductive and child health |
Department of Clinical Research,second floor ,JM STREET PAREL MUMBAI
Mumbai
MAHARASHTRA |
9971719864
gdeepti167@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ICMR NIRRCH HUMAN ETHICS COMMITTEE |
Approved |
| KEM ETHICS COMMITTEE |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R874||Abnormal immunological findings inspecimens from female genital organs, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Age 18-55
2. Sexually active
3. Women willing to come for follow up
4. Women having single sexual partners
|
|
| ExclusionCriteria |
| Details |
1. Asymptomatic women first time
2. Women not taken any antibiotic or antifungal for last 4 weeks
3. Have hypersensitivity or a contraindication to all first line drugs used to treat BV
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Identify the species common in treatment failure ,relapse and recurrent Bacterial vaginosis
2.It will help to know the prevalence of recurrent,relapse and treatment faliure BV
|
7 days,30-40,6 months,9 months,one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Common Sexually transmitted infections among women taking treatment for STI |
one year |
|
|
Target Sample Size
|
Total Sample Size="1067"
Sample Size from India="1067"
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)
|
15/01/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [gdeepti167@gmail.com].
- For how long will this data be available start date provided 23-10-2025 and end date provided 23-08-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Summary: Background-Bacterial vaginosis is a highly prevalent reproductive tract infection with reported prevalence from India range from 21% to 44.8% in different settings. Despite giving standard antimicrobials like metronidazole or secnidazole the short term cure is 30-40% in international studies recurrence rate is high greater than 50%. Novelty- This prospective study will help us to understand the burden of women suffering from recurrent/relapse and treatment failure BV. It will correlate the changes in vaginal microbiota, Nugent score, Amsel criteria and inflammatory markers and thereby give composite information on women suffering from recurrent/relapse/treatment failure and compare it those in remission. Objectives- To assess the profile and possible determinants of recurring or relapse or treatment failure BV Methods-Women reporting with complaints of lower genital tract infection will be screened and those with BV will be identified. This group will be given treatment as per syndromic approach and will be followed up to identify relapse, reoccurrence, treatment failure and remission cases. Vaginal swab, cervicovaginal lavage and gram staining samples will be collected and analyzed using Nugent score, Amsel criteria,16S rRNA gene sequencing(three times) and cytokine analysis(three times) Expected outcome-This study will identify the specific species common in treatment failure ,relapse and recurrent Bacterial vaginosis. This study will be give insights into longitudinal changes in the host immune response. This study will be further used to design a randomized control trial, based on the evolving treatment options of recurrent or persistent BV |