Infection, BacterialNCT04287504
Point-of-care Tests for Bacterial Vaginosis and Candidosis
An observational study of Infection, Bacterial and Infection, Fungal, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Vaginal infection in early pregnancy is associated with an increased risk of spontaneous preterm delivery and late miscarriage. Most studies presume that vaginal infections are responsible for up to 40% of preterm birth. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infection, Bacterial, Infection, Fungal, Preterm Birth
- What is being tested?
- SavvyCheck Vaginal Yeast Test and OSOM BVBLUE Test
- How many people
- 400 participants
- Where
- 1 siteAustria
- Study dates
- 14 Feb 2020to 31 Jul 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Recruitement will take place during routine birth registration at the obstetric outpatient clinic at the Department of Obstetrics and Gynecology at the Medical University of Vienna. All data will be collected anonymized and encoded with numbers. Pregnant women will be screened for asymptomatic and symptomatic vaginal infection via Gram stain as part of routine management. Vaginal smears will be assessed by sterile swabs from the lateral vaginal wall and posterior fornix vaginae. Two swabs will be collected. The second swab will be taken for study purposes to undergo the OSOM BVBLUE Test for bacterial vaginosis or the SavvyCheck Vaginal Yeast Test for vaginal candidosis.
Who may be able to join
- Legal age (Participants must be 18 years or over)
- Singleton pregnancy
- No recent therapy with antibiotics within the last two weeks
- No application of the following in the previous 72 hours before testing: vaginal ointments/crèmes, douches, spermicides, vaginal lubricants or feminine sprays
Who cannot join
- Age below 18 years
- Multiple pregnancy
- Recent treatment with antibiotics
- Application of the following in the previous 72 hours: vaginal ointments/crèmes, douches, spermicides, vaginal lubricants or feminine sprays
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Dept. of Obstetrics and Gynecology
Vienna, 1090
Philipp Foessleitner, MD BSc, +43140400 ext. 28220, philipp.foessleitner@meduniwien.ac.at
Alex Farr, MD PhD, +43140400 ext. 28220, alex.farr@meduniwien.ac.at
About this study
Official title: Validation of the OSOM BVBLUE Test for Bacterial Vaginosis and the SavvyCheck Vaginal Yeast Test for Vaginal Candidosis: A Prospective Study
Vaginal infection in early pregnancy is associated with an increased risk of spontaneous preterm delivery and late miscarriage. Most studies presume that vaginal infections are responsible for up to 40% of preterm birth. Although the causative microorganisms of vaginal infections are manifold, the three pathogens most commonly associated with vaginal infections are Gardnerella vaginalis, Candida albicans and Trichomonas vaginalis. The aim of this prospective study is the validation of the point-of-care tests OSOM BVBLUE for bacterial vaginosis and SavvyCheck Vaginal Yeast Test for candidosis in comparison to Gram stain.
Read the detailed description
In the present study, it should be examined whether the OSOM BVBLUE for bacterial vaginosis and the SavvyCheck Vaginal Yeast Test for vaginal candidosis are superior, equal/comparable or inferior to diagnosis on Gram stained smears. The point-of-care-tests are potential tools for the adequate diagnosis of bacterial vaginosis and vaginal candidosis in early pregnancy, since the prevention of these infections, as well as the infection screening per se, have the potential to prevent preterm birth and reduce the rate of late abortion. Point-of-care-tests are easy to perform, relatively cheap, and widely available. Routine implementation of the tests would be an effective contribution to the reduction of preterm labor and late-onset mortality.
- Conditions
- Infection, Bacterial, Infection, Fungal, Preterm Birth
- Being tested
- SavvyCheck Vaginal Yeast Test, OSOM BVBLUE Test
- Keywords
- point-of-care test, validation, preterm birth, bacterial vaginosis, candidosis
- Medical subject headings
- Bacterial Infections, Mycoses, Premature Birth, Vaginosis, Bacterial, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SavvyCheck Vaginal Yeast TestDiagnostic test
Point-of-care test for the detection of vaginal candidosis
OSOM BVBLUE TestDiagnostic test
Point-of-care test for the detection of bacterial vaginosis
| Study group | Role | What they receive |
|---|---|---|
| Yeast, control | Women negative for vulvovaginal candidosis on Gram stain smear. Receives: Diagnostic Test: SavvyCheck Vaginal Yeast Test | |
| Yeast, study group | Women positive for vulvovaginal candidosis on Gram stain smear. Receives: Diagnostic Test: SavvyCheck Vaginal Yeast Test | |
| Bacterial vaginosis, control | Women negative for bacterial vaginosis on Gram stain smear. Receives: Diagnostic Test: OSOM BVBLUE Test | |
| Bacterial vaginosis, study group | Women positive for bacterial vaginosis on Gram stain smear. Receives: Diagnostic Test: OSOM BVBLUE Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test result of OSOM BVBLUE Test or SavvyCheck Vaginal Yeast Test
Result of point-of-care test
Measured: 10 minutes
Secondary outcomes (1)
Gestational age of delivery
To assess preterm delivery rate
Measured: approx. 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start14 Feb 2020
- Primary completion18 Mar 2021
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Farr, MD PhD, Medical University of Vienna
- Investigators
- Herbert Kiss, MD MBA, Study director, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287504
- Sponsor's protocol ID
- 2115-2019
- Status last verified
- Mar 2021
- First submitted
- 25 Feb 2020
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: on request
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the OSOM BVBLUE Test for Bacterial Vaginosis and the SavvyCheck Vaginal Yeast Test for Vaginal Candidosis: A Prospective Study
- ClinicalTrials.gov ID
- NCT04287504
- Acronym / sponsor ID
- 2115-2019
- Conditions
- Infection, Bacterial, Infection, Fungal, Preterm Birth
- Keywords
- point-of-care test, validation, preterm birth, bacterial vaginosis, candidosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 18 Mar 2021 (actual)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 27 Feb 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.
Vaginal infection in early pregnancy is associated with an increased risk of spontaneous preterm delivery and late miscarriage. Most studies presume that vaginal infections are responsible for up to 40% of preterm birth. Although the causative microorganisms of vaginal infections are manifold, the three pathogens most commonly associated with vaginal infections are Gardnerella vaginalis, Candida albicans and Trichomonas vaginalis. The aim of this prospective study is the validation of the point-of-care tests OSOM BVBLUE for bacterial vaginosis and SavvyCheck Vaginal Yeast Test for candidosis in comparison to Gram stain.
Detailed description
In the present study, it should be examined whether the OSOM BVBLUE for bacterial vaginosis and the SavvyCheck Vaginal Yeast Test for vaginal candidosis are superior, equal/comparable or inferior to diagnosis on Gram stained smears. The point-of-care-tests are potential tools for the adequate diagnosis of bacterial vaginosis and vaginal candidosis in early pregnancy, since the prevention of these infections, as well as the infection screening per se, have the potential to prevent preterm birth and reduce the rate of late abortion. Point-of-care-tests are easy to perform, relatively cheap, and widely available. Routine implementation of the tests would be an effective contribution to the reduction of preterm labor and late-onset mortality.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Yeast, control | – | Diagnostic Test: SavvyCheck Vaginal Yeast TestWomen negative for vulvovaginal candidosis on Gram stain smear. |
| Yeast, study group | – | Diagnostic Test: SavvyCheck Vaginal Yeast TestWomen positive for vulvovaginal candidosis on Gram stain smear. |
| Bacterial vaginosis, control | – | Diagnostic Test: OSOM BVBLUE TestWomen negative for bacterial vaginosis on Gram stain smear. |
| Bacterial vaginosis, study group | – | Diagnostic Test: OSOM BVBLUE TestWomen positive for bacterial vaginosis on Gram stain smear. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Recruitement will take place during routine birth registration at the obstetric outpatient clinic at the Department of Obstetrics and Gynecology at the Medical University of Vienna. All data will be collected anonymized and encoded with numbers. Pregnant women will be screened for asymptomatic and symptomatic vaginal infection via Gram stain as part of routine management. Vaginal smears will be assessed by sterile swabs from the lateral vaginal wall and posterior fornix vaginae. Two swabs will be collected. The second swab will be taken for study purposes to undergo the OSOM BVBLUE Test for bacterial vaginosis or the SavvyCheck Vaginal Yeast Test for vaginal candidosis.
Key inclusion criteria (4 listed)
- Legal age (Participants must be 18 years or over)
- Singleton pregnancy
- No recent therapy with antibiotics within the last two weeks
- No application of the following in the previous 72 hours before testing: vaginal ointments/crèmes, douches, spermicides, vaginal lubricants or feminine sprays
Key exclusion criteria (4 listed)
- Age below 18 years
- Multiple pregnancy
- Recent treatment with antibiotics
- Application of the following in the previous 72 hours: vaginal ointments/crèmes, douches, spermicides, vaginal lubricants or feminine sprays
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 |
|---|---|---|
| SavvyCheck Vaginal Yeast TestPoint-of-care test for the detection of vaginal candidosis | Diagnostic test | Yeast, control, Yeast, study group |
| OSOM BVBLUE TestPoint-of-care test for the detection of bacterial vaginosis | Diagnostic test | Bacterial vaginosis, control, Bacterial vaginosis, study group |
Primary outcome
Test result of OSOM BVBLUE Test or SavvyCheck Vaginal Yeast Test
Time frame: 10 minutes
Result of point-of-care test
1 secondary outcome
Gestational age of delivery
Time frame: approx. 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Individual participant dataSharing planned: No. on request
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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.
Herbert Kiss, MD MBA study director
Medical University of Vienna
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, Bacterial and Infection, Fungal, run by Medical University of Vienna at 1 site in Austria.
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 4 inclusion and 4 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 19 Mar 2021. 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 Austria. 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 Philipp Foessleitner, MD BSc (+43140400 ext. 28220, philipp.foessleitner@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test result of OSOM BVBLUE Test or SavvyCheck Vaginal Yeast Test (time frame: 10 minutes). 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 19 Mar 2021.