Title: “Study comparing standard decolonization therapy alone versus combined with oral clindamycin for patients with MRSA throat carriage”

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What is this study about?

This study focuses on treating people who carry Methicillin-Resistant Staphylococcus Aureus (MRSA) in their throat. MRSA is a type of bacteria that is resistant to many common antibiotics and can cause serious infections. The standard treatment includes nasal ointment containing mupirocin and body wash with chlorhexidine, which are substances used to remove bacteria from the body.

The purpose of this research is to determine if adding an oral antibiotic called clindamycin to the standard treatment works better at eliminating MRSA from the throat. During the study, some participants will receive clindamycin along with the standard treatment, while others will receive a placebo with the standard treatment.

The treatment period lasts for 10 days, during which participants take the medication by mouth. The maximum daily dose of clindamycin is 1800 mg. The effectiveness of the treatment will be checked by taking throat swabs after one month and again after six months to see if the MRSA bacteria are still present.

1 Initial treatment phase

You will receive standard decolonization therapy, which includes mupirocin nasal ointment and chlorhexidin body wash.

You may also receive either oral clindamycin or a placebo (inactive substance). Neither you nor the medical staff will know which one you are receiving.

The treatment aims to eliminate MRSA (a type of bacteria) from your throat.

2 First follow-up examination

After 1 month, a throat swab will be taken to check if the MRSA bacteria are still present.

This test involves collecting a sample from your throat using a cotton swab.

The results of this test will help determine if the treatment has been successful.

3 Long-term follow-up

After 6 months, another throat swab will be taken.

This final test will check if your throat remains free of MRSA bacteria.

This examination completes your participation in the study.

Who Can Join the Study?

Must be 18 years of age or older
Must have MRSA bacteria present in the throat (MRSA stands for Methicillin-resistant Staphylococcus aureus, which is a type of bacteria resistant to common antibiotics)
Must have already completed one course of standard topical decolonization treatment (treatment that involves applying medication directly to the throat area to remove bacteria)
Can be either male or female
Must not belong to any vulnerable population groups (such as people who cannot make decisions for themselves)
Must be able to participate in a randomized clinical trial (a study where participants are randomly assigned to different treatment groups)

Who Cannot Join the Study?

Known allergy or severe sensitivity to clindamycin, mupirocin, or chlorhexidine
Current pregnancy or breastfeeding
Active gastrointestinal infection or severe digestive system problems
Use of antibiotics in the past 2 weeks
Severe liver disease (problems with liver function)
Severe kidney disease (problems with kidney function)
Current participation in other clinical trials
Unable to follow study procedures or attend follow-up visits
History of inflammatory bowel disease (chronic inflammation of digestive tract)
Presence of other serious medical conditions that could interfere with the study
History of severe adverse reactions to antibiotics
Children and adolescents under 18 years of age
People who cannot give informed consent
Active malignancy (cancer) requiring treatment
Immunocompromised patients (weakened immune system)

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hrpzzzru Hwdvwdaz	Hvidovre	Denmark
Hjezkx Hwuvmfvl	Herlev	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	02.03.2020

Trial locations

Investigated drugs:

Clindamycin Hydrochloride

Mupirocin is a topical antibiotic applied as a nasal ointment. It is used to eliminate harmful bacteria, specifically MRSA (Methicillin-resistant Staphylococcus aureus), from the nose. This medication works by stopping bacteria from growing and multiplying in the nasal passages.

Chlorhexidine is an antiseptic body wash that kills bacteria on the skin. It is used as part of the decolonization treatment to remove harmful bacteria from the body surface. This helps reduce the risk of spreading bacteria and prevents infections.

Clindamycin is an oral antibiotic taken by mouth. It works by stopping bacterial growth throughout the body. In this trial, it is being tested as an additional treatment alongside the standard decolonization therapy to see if it improves the success rate of eliminating MRSA from the throat.

MRSA Throat Carriage – A condition where methicillin-resistant Staphylococcus aureus (MRSA) bacteria colonize the throat area. The bacteria can live in the throat without causing immediate symptoms, making the person a carrier. MRSA throat carriage occurs when these antibiotic-resistant bacteria establish themselves in the throat’s mucous membranes. While carriers may not feel sick, they can potentially spread the bacteria to others. The condition can persist for extended periods if not addressed.

Trial ID:

2024-516377-69-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Title: “Study comparing standard decolonization therapy alone versus combined with oral clindamycin for patients with MRSA throat carriage”

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?