Smart hygiene solutions to support health tracking

Not yet recruiting

Conditions: Bacterial infection, unspecified, (2) ICD-10 Condition: B374||Candidiasis of other urogenital sites, (3) ICD-10 Condition: B373||Candidiasis of vulva and vagina, (4) ICD-10 Condition: N898||Other specified noninflammatory disorders of vagina, (5) ICD-10 Condition: N390||Urinary tract infection, site notspecified,
Any Healthy individuals or Patients without Vaginal and Urinary tract infection

Registration Number: CTRI/2025/04/085675

Lead Sponsor: Reckitt Benckiser (India) Pvt. Ltd.

Brief Summary: - The primary purpose of the study is to test our developed diagnostic device for the detection of vaginal infection and urinary tract infection in women. 25 patients with vaginal infection and/or urinary tract infection will be recruited for the study. 25 healthy individuals or patients without vaginal and urinary tract infection will be recruited as the control group.

- 50 vaginal swabs (2 vaginal swabs per patient) will be collected from 25 healthy individuals by the concerned physician or trained personnel in the Department of Obstetrics and Gynaecology, Kasturba Medical College and Kasturba Hospital, Manipal. 25 urine samples (2 urine containers per patient) will be collected from the same 25 healthy individuals by the concerned trained personnel in the Central Collection Centre, Kasturba Hospital, Manipal.

- 50 vaginal swabs (2 vaginal swabs per patient) will be collected from 25 patients with vaginal infection and/or urinary tract infection by the concerned physician or trained personnel in the Department of Obstetrics and Gynaecology, Kasturba Medical College and Kasturba Hospital, Manipal. 25 urine samples (2 urine containers per patient) will be collected from the same 25 patients with vaginal infection and/or urinary tract infection by the concerned trained personnel in the Central Collection Centre, Kasturba Medical College and Kasturba Hospital, Manipal.

- One sample of vaginal swab and one urine container collected per patient or healthy individual will be sent to the Department of Microbiology, Kasturba Medical College and Kasturba Hospital, Manipal for conventional testing i.e. microbial culture following the standard protocol of the hospital.

- The remaining one sample of vaginal swab and one urine container per patient or healthy individual will be used to validate the developed diagnostic platform for the detection of vaginal and urinary infection biomarkers and pathogens in Department of Biotechnology, Manipal Institute of Technology, Manipal.

- Anonymized samples will be provided by the concerned Physician for the study.

- The consent from the patients will be taken by the concerned Physician or trained personnel in the Department of OBG for sample collection.

- Basic patient data including only age and any secondary health condition (such as Diabetes or other condition acting as a contributing factor to the infection) will be collected with permission from the concerned Physician.

- The results obtained from the developed device will not be utilized/ will not interfere with the patient intervention. The treatment to the patient if any will be only based on the diagnosis by the concerned Physician and conventional testing performed in the hospital.

- The developed diagnostic platform will be tested for diagnostic accuracy in terms of sensitivity, specificity and other parameters using the clinical samples and compared with the Gold standard method i.e. microbial culture.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 50

Inclusion Criteria

Control group: Inclusion criteria: Any Healthy individuals/Patients without Vaginal and Urinary tract infection visiting the OBG department, Age group 20-50.
Patient group: Inclusion criteria: Patients with vaginal infection and/or urinary tract infection, Age group 20-50.

Exclusion Criteria

Control group: Exclusion criteria: Pregnant women, Vulnerable group, Patients who recently consumed antibiotics and antifungals, Patients having viral infections, symptoms of jaundice, hepatitis, HIV, Leptospira, Chyluria etc.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The developed diagnostic platform will be tested for diagnostic accuracy in	1 year
terms of sensitivity, specificity and other parameters using the clinical vaginal swab and urine samples, and compared with the	1 year
Gold standard method i.e. microbial culture.	1 year

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Manipal Institute of Technology, Manipal,Kasturba Medical College and Kasturba Hospital, Manipal
🇮🇳
Udupi, KARNATAKA, India
Manipal Institute of Technology, Manipal,Kasturba Medical College and Kasturba Hospital, Manipal
🇮🇳Udupi, KARNATAKA, India
Dr Naresh Kumar Mani
Principal investigator
8110028989
naresh.mani@manipal.edu