NCT06616168

Brief Summary

Research concerning women pathogenic microflora during different conditions

Trial Health

75
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
16mo left

Started Sep 2023

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress67%
Sep 2023Aug 2027

Study Start

First participant enrolled

September 1, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

September 27, 2024

Status Verified

August 1, 2024

Enrollment Period

3 years

First QC Date

August 28, 2024

Last Update Submit

September 24, 2024

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (2)

  • Estimation of the immune activity

    Detection of quantities of different immune cells: lymphocytes, leukocytes, neutrophils, eosinophils

    1 month

  • Quantities of vaginal microflore bacteria

    Detection of quantities of vaginal microflore bacteria before and after antibiotic therapy (in TBC)

    2 months

Secondary Outcomes (1)

  • Quantities of bacteria in urine

    2 months

Study Arms (3)

Women with bacterial vaginosis

EXPERIMENTAL

Women with bacterial vaginosis (symptomatic or asymptomatic)

Diagnostic Test: Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest)Drug: Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin)Combination Product: Suppositoria for vaginal microflora recovery (Giynoflor)Drug: Antifungal therapy (Mostly Fluconazole, Nystatin, Amphotericin B)

Pregnant women

EXPERIMENTAL

Pregnant women with different ifections

Diagnostic Test: Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest)Drug: Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin)Combination Product: Suppositoria for vaginal microflora recovery (Giynoflor)Drug: Antifungal therapy (Mostly Fluconazole, Nystatin, Amphotericin B)

Women with asymptomic infections

EXPERIMENTAL

Women with asymptomic infections of urogenital tract

Diagnostic Test: Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest)Drug: Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin)Combination Product: Suppositoria for vaginal microflora recovery (Giynoflor)

Interventions

Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest)DIAGNOSTIC_TEST

Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest) produced by Erba Lachema leads to bacteria detection via biochemical features

Pregnant womenWomen with asymptomic infectionsWomen with bacterial vaginosis
Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin)DRUG

Antibiotic therapy after the results of antibiotic sensitivity test. Aminoglycosides, Carbapenems, Cephalosporins, Fluoroquinolones, Oxazolidinones are used. Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin are used for the therapy.

Pregnant womenWomen with asymptomic infectionsWomen with bacterial vaginosis
Suppositoria for vaginal microflora recovery (Giynoflor)COMBINATION_PRODUCT

Prescription of suppositoria for vaginal microflora recovery after antibiotic therapy. Probiotic grug includes Lactobacilli acidophillis as the main compound.

Pregnant womenWomen with asymptomic infectionsWomen with bacterial vaginosis
Antifungal therapy (Mostly Fluconazole, Nystatin, Amphotericin B)DRUG

Prescription of antifungal drugs. Triazoles (Fluconazole, Itraconazole, Voriconazole), Imidazoles (Ketoconazole), Nystatin and Amphotericin B are used the most

Pregnant womenWomen with bacterial vaginosis

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • urogenital infections, pregnancy

You may not qualify if:

  • healthy microflora

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danylo Halytsky Lviv National Medical University

Lviv, 79000, Ukraine

Location

Related Links

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Penicillin GCeftriaxoneDoxycyclineClindamycinNystatinAmphotericin B

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Penicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCefotaximeCephacetrileCephalosporinsThiazinesTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsLincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingGlycosidesCarbohydratesMacrolidesLactonesPolyketides

Study Officials

  • Yulian Konechnyi

    Danylo Halytsky Lviv National Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2024

First Posted

September 27, 2024

Study Start

September 1, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2027

Last Updated

September 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

UA(1)