InfectionNCT04552210
Mannose Binding Lectin Gene Polymorphism Versus Microbial Virulence in the Pathogenesis of Vulvovaginal Candidiasis
An observational study of Infection, run by Aljazeera Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infection
- What is being tested?
- blood sample
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Sep 2020to 20 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Adult
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.
Who may be able to join
- 1. 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: Mannose Binding Lectin Gene Polymorphism Versus Microbial Virulence in the Pathogenesis of Vulvovaginal Candidiasis in Egypt
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.
Read the detailed description
Nevertheless, under certain circumstances, this co-existence can turn into a pathologic state followed by symptomatic disease
- Conditions
- Infection
- Being tested
- blood sample
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleDiagnostic test
Whole blood was collected on EDTA (1mg/ml) to prevent clotting and DNA degradation.
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of women who have mutation in MBL2 gene polymorphism
women who have mutation in MBL2 gene polymorphism
Measured: a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start16 Sep 2020
- Primary completion15 Dec 2020 (estimated)
- Study completion20 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, Study chair, Algezeera hospitaland National Research Centre ,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552210
- Sponsor's protocol ID
- Mannose
- Status last verified
- Nov 2020
- First submitted
- 11 Sep 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mannose Binding Lectin Gene Polymorphism Versus Microbial Virulence in the Pathogenesis of Vulvovaginal Candidiasis in Egypt
- ClinicalTrials.gov ID
- NCT04552210
- Acronym / sponsor ID
- Mannose
- Conditions
- Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 20 Feb 2021 (estimated)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Nevertheless, under certain circumstances, this co-existence can turn into a pathologic state followed by symptomatic disease
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 1. 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleWhole blood was collected on EDTA (1mg/ml) to prevent clotting and DNA degradation. | Diagnostic test | – |
Primary outcome
the number of women who have mutation in MBL2 gene polymorphism
Time frame: a month
women who have mutation in MBL2 gene polymorphism
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Alalfy study chair
Algezeera hospitaland National Research Centre ,Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by Aljazeera Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Alalfy (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of women who have mutation in MBL2 gene polymorphism (time frame: a month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.