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Study on Clindamycin and Rifampicin for Treating Infections in Patients with Obesity, Fracture-Related Infections, Hidradenitis Suppurativa, or Prosthetic Joint Infections

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What is this trial about?

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

This clinical trial is focused on studying the treatment of certain infections using the medication clindamycin. The infections being studied include fracture-related infections, hidradenitis suppurativa (a skin condition that causes small, painful lumps under the skin), and prosthetic joint infections. The trial will also examine how the medication rifampicin and a person's body weight might affect the treatment with clindamycin.

The purpose of the study is to understand how clindamycin is processed in the body and how effective it is when used alone or in combination with rifampicin. Participants will receive either clindamycin by itself or a combination of clindamycin and rifampicin. The study will monitor how the body absorbs and eliminates clindamycin, as well as the overall effectiveness of the treatment in curing the infections.

Participants will take the medication orally, and the study will last for a period of up to 12 weeks. The trial aims to gather information on how well the treatment works and to identify any factors that might influence its success, such as the participant's weight or the use of additional medications like rifampicin. The ultimate goal is to improve treatment strategies for these infections.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initiation of treatment
Upon joining the study, the participant will begin treatment with clindamycin. This medication is used to treat infections and will be administered orally.
Participants in Cohort 1 and 2 will receive clindamycin alone, while those in Cohort 3 and 4 will receive a combination of clindamycin and rifampicin.
Step 2
Medication administration
Clindamycin will be taken orally. The dosage and frequency will be determined by the study protocol and the participant's specific needs.
For those in Cohort 3 and 4, rifampicin will also be administered orally alongside clindamycin.
Step 3
Monitoring and assessments
Throughout the trial, participants will undergo regular monitoring to assess the effectiveness of the treatment and to ensure safety.
Pharmacokinetic parameters such as the area under the curve (AUC), volume of distribution (Vd), clearance, and elimination half-life will be measured to understand how the body processes the medication.
Step 4
Evaluation of treatment effectiveness
The primary goal is to evaluate the pharmacokinetic parameters of clindamycin and the influence of body weight and rifampicin treatment.
Secondary evaluations will focus on the effectiveness of the treatment and achieving a clinical cure.
Step 5
Completion of trial
The trial is expected to conclude by December 31, 2028. Participants will be informed of the outcomes and any further steps if necessary.

Who can join the trial?

7 criteria

The participant must provide voluntary written informed consent, or their legally authorized representative must do so, before any screening procedures begin.
The participant must be at least 18 years old at the time of signing the Informed Consent Form.
The participant must use highly effective methods of birth control. These methods should have a low failure rate, meaning less than 1% chance of failure per year, when used consistently and correctly. Examples include implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), true sexual abstinence (not having heterosexual intercourse during the entire period of risk associated with the trial treatment), or having a partner who has had a vasectomy.
The participant must have a BMI (Body Mass Index) of less than 30 for Cohorts 1 and 3, or a BMI of 30 or more for Cohorts 2 and 4.
The participant must have started treatment with clindamycin alone (Cohorts 1 and 2) or with a combination of clindamycin and rifampicin (Cohorts 3 and 4).
The participant must have a positive culture of Staphylococcus spp. (a type of bacteria) that is sensitive to clindamycin and rifampicin.
The participant must be admitted to the orthopedic, traumatology, or dermatology ward.

Who cannot join the trial?

4 criteria

Patients with **fracture-related infections** cannot participate. This means if you have an infection related to a broken bone, you are not eligible.
Patients with **hidradenitis suppurativa** cannot participate. This is a skin condition that causes small, painful lumps under the skin.
Patients with **prosthetic joint infections** cannot participate. This refers to infections that occur in artificial joints, like a hip or knee replacement.
Patients who are part of a **vulnerable population** cannot participate. This generally means groups of people who might need special protection, like children or those unable to give consent.

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Katholieke Universiteit te Leuven
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Leuven, Belgium

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Investigated drugs

Clindamycin
is an antibiotic used to treat various types of infections. In this trial, researchers are studying how the body absorbs and processes clindamycin, especially in people with different body weights. They want to understand how well clindamycin works in treating infections.
Rifampicin
is another antibiotic that is often used to treat infections, including tuberculosis. In this trial, researchers are examining how taking rifampicin at the same time as clindamycin affects the way clindamycin works in the body. They are interested in seeing if rifampicin changes how clindamycin is absorbed and processed.

What is already known about the treatment

Clindamycin – Clindamycin is typically administered orally or intravenously, depending on the severity of the infection. It is currently well-established in medical practice and literature as an effective antibiotic. The main therapeutic indications for clindamycin include treating infections such as fracture-related infections, hidradenitis suppurativa, and prosthetic joint infections. At the molecular level, clindamycin works by inhibiting bacterial protein synthesis, which prevents bacteria from growing and multiplying. It is classified pharmacologically as a lincosamide antibiotic.

Investigated diseases

Fracture-related infections
These infections occur when bacteria invade the site of a bone fracture, leading to inflammation and potential complications in the healing process. They can cause symptoms such as redness, swelling, and pain at the fracture site. If not managed, the infection can spread to surrounding tissues and delay bone healing. The condition often requires medical intervention to prevent further complications.
Hidradenitis suppurativa
This is a chronic skin condition characterized by painful lumps under the skin, typically in areas where skin rubs together, such as the armpits, groin, and under the breasts. These lumps can become inflamed and may rupture, leading to scarring. The condition tends to flare up and can be persistent, affecting daily activities and quality of life. It is often associated with other systemic conditions.
Prosthetic joint infections
These infections occur when bacteria infect a joint that has been replaced with an artificial implant, such as a hip or knee replacement. Symptoms may include joint pain, swelling, and warmth around the joint. The infection can compromise the function of the joint and may lead to loosening of the implant. It often requires medical attention to address the infection and preserve joint function.