NCT04552210

Brief Summary

The vaginal mucosa is inhabited by both fungal and bacterial microorganisms which normally co-exist with the host in a tightly regulated and commensal manner.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

September 16, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2021

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

September 11, 2020

Last Update Submit

November 7, 2020

Conditions

Infection

Outcome Measures

Primary Outcomes (1)

  • the number of women who have mutation in MBL2 gene polymorphism

    women who have mutation in MBL2 gene polymorphism

    a month

Interventions

blood sampleDIAGNOSTIC_TEST

Whole blood was collected on EDTA (1mg/ml) to prevent clotting and DNA degradation.

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale with candidal infection
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Married females in the reproductive age period. 2. Females complaining of vaginal discharge (whitish and scanty), itching, dyspareunia, pruritis, and signs of vulvovaginitis ie. erythema.

You may qualify if:

  • \. Married females in the reproductive age period. 2. Females complaining of vaginal discharge (whitish and scanty), itching, dyspareunia, pruritis, and signs of vulvovaginitis ie. erythema.

You may not qualify if:

  • females who attended the same clinic in the same period, matched the cases regarding the age group, without having Candida infection as confirmed by culture of vaginal swabs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algazeerah

Giza, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Detection of MBL2 single nucleotide polymorphisms (SNPs): The three SNPs in the promoter regions; rs11003125 (L/H), rs7096206 (Y/X), rs7095891 (P/Q), and one SNP rs1800450 (Gly54Asp) present in codon 54 of MBL2 were genotyped using ARMS-PCR (amplification refractory mutation system- PCR)

MeSH Terms

Conditions

Infections

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Mahmoud Alalfy

    Algezeera hospitaland National Research Centre ,Egypt

    STUDY CHAIR

Central Study Contacts

Mahmoud Alalfy

CONTACT

01002611058mahmoudalalfy@ymail.com

Ahmed Elgazzar

CONTACT

01014005959elgazzara50@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 17, 2020

Study Start

September 16, 2020

Primary Completion

December 15, 2020

Study Completion

February 20, 2021

Last Updated

November 10, 2020

Record last verified: 2020-11

Locations

EG(1)