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A study comparing furazidin and clindamycin for women with bacterial vaginosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at bacterial vaginosis, which is a common vaginal infection caused by an imbalance of bacteria. The study will compare two different treatments for this condition. One treatment is furazidin vaginal tablets, which contain a substance that stops bacteria from growing. The other treatment is clindamycin vaginal cream, which is an antibiotic that fights bacterial infections. Both medications are used by inserting them into the vagina. The treatment with either medication will last for 7 days.

The purpose of this study is to show that treatment with furazidin vaginal tablets works as well as treatment with clindamycin vaginal cream for bacterial vaginosis. During the study, women will be randomly assigned to receive either furazidin tablets or clindamycin cream. After completing the treatment, participants will attend several follow-up visits to check if the infection has cleared and to monitor for any side effects. The study will also check whether the infection comes back within 12 weeks after treatment ends.

The study will measure how many women are cured of the infection by checking for specific signs such as abnormal vaginal discharge, odor, and the presence of certain cells under a microscope. Additional measurements will include laboratory tests to confirm the infection is gone, tracking any unwanted side effects from the medications, and assessing how the treatment affects quality of life. Follow-up visits will continue for several months to monitor for any return of the infection.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment period
At the beginning of the study, you will be randomly assigned to receive one of two treatments for bacterial vaginosis, which is an infection caused by an imbalance of bacteria in the vagina.
You will receive either furazidin vaginal tablets at a dose of 5 mg or clindamycin vaginal cream at a concentration of 2%. Both medications are inserted into the vagina.
The specific dosage schedule, frequency of use, and total duration of treatment will be determined according to the study protocol. You will receive detailed instructions on how to use your assigned medication.
During the treatment period, you must avoid using any other vaginal products, including spermicides, condoms, and tampons.
Step 2
First follow-up assessment
Between day 8 and day 10 after starting treatment, you will attend a follow-up visit called the test of cure visit.
At this visit, the doctor will evaluate whether the treatment has been successful by checking for specific signs: resolution of abnormal vaginal discharge, a negative whiff test (a test that checks for a fishy odor), and examination under a microscope to ensure that clue cells (specific cells seen in bacterial vaginosis) make up less than 20% of the cells observed.
This assessment will determine if you have achieved clinical cure, meaning the infection has been successfully treated.
Step 3
Second follow-up assessment
Between day 21 and day 30 after starting treatment, you will attend another follow-up visit.
At this visit, the doctor will perform a Nugent score assessment, which is a laboratory test that examines a sample from the vagina under a microscope to evaluate the types and amounts of bacteria present. A score ranging from 0 to 3 indicates a normal, healthy bacterial balance.
This visit will help determine if the normal bacterial balance in the vagina has been restored and maintained after treatment.
Step 4
Long-term follow-up period
You will be monitored for 12 weeks after the test of cure visit to check if the bacterial vaginosis returns.
During this period, the doctor will assess whether the infection has come back by using the same criteria as in the first follow-up visit.
This long-term observation helps determine if the treatment provides lasting results.
Step 5
Final follow-up visit
At least 13 or 14 weeks after the end of treatment, you will attend a final follow-up visit.
At this visit, you will be asked to complete a questionnaire about your quality of life using a visual analog scale, which is a simple tool where you mark on a line how you feel about certain aspects of your health and daily life.
This assessment will help evaluate how the treatment and the condition have affected your overall well-being from the start of the study to the end of the observation period.
Step 6
Safety monitoring throughout the study
Throughout the entire study period, any side effects or unexpected health problems will be recorded and monitored.
You should report any new symptoms or health concerns to the study doctor during your visits or as instructed by the study team.
Both minor side effects and serious health events will be tracked to evaluate the safety of the treatment you receive.

Who can join the trial?

9 criteria

You must sign a written informed consent form before any study-related evaluations are performed.
You must be a female patient between 18 and 65 years of age.
You must have bacterial vaginosis, which is an infection caused by an imbalance of bacteria in the vagina. This diagnosis must be confirmed based on Amsel's criteria, which are a set of tests used by doctors to identify this condition.
You must have a negative PAP test result within the past 12 months. A PAP test is a screening test that checks for abnormal cells in the cervix. The test must show no signs of LSIL (low-grade abnormal cells), HSIL (high-grade abnormal cells), or cancer. If you do not have a recent negative test, one will be done during the screening visit. If the result is ASCUS, which means unclear or uncertain findings, the test will need to be repeated.
You must have a negative pregnancy test before joining the study. A pregnancy test checks whether you are pregnant.
You must not be breastfeeding or planning to become pregnant during the study period, including follow-up visits.
If you are able to become pregnant, you must agree to use a highly effective method of birth control from the screening visit until the last follow-up visit. Highly effective methods include hormonal contraceptives such as birth control pills, patches, or intrauterine devices that prevent pregnancy with less than 1% failure rate. You may also choose to abstain from sexual intercourse during this time. If you have gone through menopause, meaning you have not had a menstrual period for 12 months, you do not need to use birth control.
You must be willing to avoid using any intravaginal products during the treatment period. Intravaginal products are items inserted into the vagina, such as spermicides, condoms, tampons, and similar products.
You must have a positive result on the BV blue test, which is a test used to confirm the presence of bacterial vaginosis.

Who cannot join the trial?

16 criteria

You are pregnant, which means you are expecting a baby
You are breastfeeding, which means you are feeding your baby with breast milk
You are planning to become pregnant during the study period
You have an allergy or unusual reaction to furazidin, clindamycin, or any ingredients in these medicines
You have severe liver disease, which means your liver is not working properly
You have severe kidney disease, which means your kidneys are not working properly
You are taking certain medicines that may interact with the study treatment
You have used antibiotics, which are medicines that fight bacterial infections, within a certain time period before joining the study
You have used vaginal products such as creams, gels, or washes within a certain time before the study
You have another vaginal or sexually transmitted infection, which is an infection passed through sexual contact
You have your monthly bleeding or menstruation at the time of starting treatment
You have had sexual intercourse within a short time before the study examinations
You have a condition that weakens your immune system, which is your body's defense against infections, such as HIV or if you are taking medicines that suppress immunity
You have diabetes that is not well controlled, which is a condition with high blood sugar levels
You have participated in another clinical study recently
You are unable to follow the study requirements or attend all required visits

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Azienda Ospedaliera Universitaria Senese
Siena, Italy
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Azienda Ospedaliero Universitaria Di Modena
Modena, Italy
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Azienda Ospedaliero Universitaria Pisana
Pisa, Italy

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Investigated drugs

Furazidin vaginal tablets
are tablets that are inserted into the vagina to treat bacterial vaginosis, which is an infection caused by an imbalance of bacteria in the vagina. This medication works by fighting the harmful bacteria that cause the infection.
Clindamycin vaginal cream
is a cream that is applied inside the vagina to treat bacterial vaginosis. This antibiotic medication helps to eliminate the bacteria responsible for the infection and restore the normal balance of bacteria in the vagina.

Clindamycin Phosphate

What is already known about the treatment

Furazidin
Furazidin is an antibacterial medication being studied in vaginal tablet form for the local treatment of bacterial vaginosis, a common vaginal infection caused by an imbalance of bacteria. The vaginal tablets are inserted directly into the vagina, where they work by killing harmful bacteria and helping restore the normal bacterial balance. Furazidin belongs to a group of medicines called nitrofuran antibiotics, which work by damaging the genetic material inside bacterial cells, preventing them from growing and multiplying. This medication is currently being tested in clinical trials to compare its effectiveness and safety with other standard treatments for bacterial vaginosis.
Clindamycin
Clindamycin is an established antibiotic available as a vaginal cream that is applied inside the vagina to treat bacterial vaginosis. This medication is already approved and widely used in medical practice as a standard treatment option for this condition. Clindamycin works by stopping bacteria from making proteins they need to survive and grow, which ultimately kills the harmful bacteria causing the infection. It belongs to a class of antibiotics called lincosamides and is considered an effective and safe treatment for restoring the normal balance of vaginal bacteria.

Investigated diseases

Bacterial Vaginosis – Bacterial vaginosis is a condition that occurs when the normal balance of bacteria in the vagina is disrupted. The healthy bacteria that usually dominate the vaginal environment decrease in number, while other types of bacteria multiply excessively. This imbalance leads to changes in the vaginal discharge, which may become thin, grayish-white in color, and develop an unpleasant fishy odor, particularly after sexual intercourse. Women with this condition may also experience vaginal itching or burning, though some women have no noticeable symptoms at all. The condition develops when harmful bacteria outnumber the protective lactobacilli that normally maintain the acidic environment of the vagina. Bacterial vaginosis can recur even after the bacterial balance has been temporarily restored.