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Evaluation of multiplex PCR for diagnosing bacterial vaginosis and candidiasis in fluor vaginalis

Evaluation of multiplex PCR for diagnosing bacterial vaginosis and candidiasis in fluor vaginalis - FluVa-study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42189
Enrollment
80
Registered
2015-01-16
Start date
2015-01-22
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial vaginosis and candidiasis - vaginal (yeast) infections

Interventions

None listed

Sponsors

Bronovo Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Major criteria: Increase of discharge Odor of discharge;Minor criteria: Color change of discharge Itching, irritation or redness

Exclusion criteria

Exclusion criteria: Postmenopausal women Immune compromised women Women who had a vaginal ultrasound with gel on the day of inclusion Women with complaints of vulva in stead of vagina Women who have been treated with antibiotics or clotrimazole for vaginal infections the last 3 months

Design outcomes

Primary

MeasureTime frame
A. Outcome of culture on Gardnerella vaginalis, C. albicans, yeasts, trichomoniasis and beta-hemolytic streptococcal infections - Positive - Negative - can't be measured B. Outcome gram-stain for bacterial vaginosis - Positive - Negative - can't be measured C. Outcome Multiplex PCR analysis on bacterial vaginosis, atopobium vaginae, lactobacillus spp. Negative 1. Normocenosis: normal vaginal flora Positive Anaerobic disbiosis: bacterial vaginosis with explanation disbalanced vaginal flora, significantly more anaerobe bacteria Doubtful positive 3. Mezocenosis: changed vaginal flora with increased anaerobe bacteria. 4. Unexplained disbiosis: decreased lactobacillus, no increase of anaerobe bacteria. Can't be measured 5. Result of test is unreliable: not specified but will be given to a specific grade of Cq of total bacteria. D. Outcome Multiplex PCR analysis on Candida species: AmpliSens C. albicans, C. glabrata, C. krusei-MULTIPRIME-FRT PCR. - Positive - Negative - can't be measured E. Outcome PCR analysis on Trichomoniasis - Positive - Negative - can't be measured F. Outcome PCR analysis on C. trachomatis - Positive - Negative - can't be measured G. Outcome PCR analysis on N. gonorrhoeae - Positive - Negative - can't be measured

Secondary

MeasureTime frame
Clinical diagnoses based on complaints and vaginal inspection on which we give a treatment. - Bacterial vaginois - Candidiasis - Trichomoniasis - Infection with ß -hemolytic streptococcal group A - C. trachomatis - N. gonorrhoeae Presentation of symptoms - Duration of symptoms - Amount of discharge - Color discharge - Fishy odor of discharge - Fishy odor of discharge after intercourse - Itching - Burning - Vaginal redness of irritation - Pain - Symptoms related to menstruation cycle - Dyspareunia - Seriousness of complaints - Bleeding after intercourse - Symptoms gone after treatment - Dysuria - Abdominal pain Physical examination - Vaginal redness or irritation - Amount of discharge - Color of discharge - Friable white discharge - Frothy white discharge - Purulent discharge - Bleeding cervix at speculum examination - Erythematous cervix - Fishy odor of discharge - Fishy odor after KOH - Acidity of discharge - Clue cells on wet mount - Motile trichomonads on wet mount - Budding yeast, pseudohyphae, and hyphae on a wet mount of the discharge; adding 10 percent potassium hydroxide Time needed to do the following test in minutes - Acidity measurement - whiff-amine test - Microscopial evalution with wet mount or potassium hydroxide Outcome microbioma analysis with bacterial 16S rDNA analysis by nex-gen sequencing (Illumina MiSeq) - Positieve - Negative - Can't be measured

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)