Study Comparing Rifabutin and Rifampicin for Adults with Staphylococcal Prosthetic Joint Infection Using DAIR Strategy

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What is this study about?

This clinical trial is focused on treating a type of infection called staphylococcal prosthetic joint infection. This infection occurs in people who have had joint replacement surgery, such as a hip or knee replacement, and is caused by bacteria known as staphylococci. The study is comparing two medications: Rifabutin and Rifampicin. Both are antibiotics taken orally in the form of capsules. The goal is to see if Rifabutin is as effective as Rifampicin in treating this infection.

The study will involve participants who have this type of infection and are being treated with a method called the DAIR strategy, which stands for debridement, antibiotics, and implant retention. This means that the infected area is cleaned, antibiotics are given, and the joint implant is kept in place. Participants will be randomly assigned to receive either Rifabutin or Rifampicin for a period of up to 12 weeks. The study will monitor the participants for one year to see if the treatment is successful and if there are any side effects.

The main focus is to determine if the infection is effectively treated without the need for additional surgery, and to ensure that the treatment does not cause serious side effects. Participants’ quality of life and any changes in their condition will also be assessed over a period of up to two years. This study aims to provide valuable information on the best treatment options for people with staphylococcal prosthetic joint infections.

1 joining the study

Upon joining the study, participation is confirmed through a signed informed consent form. Eligibility is based on specific criteria, including age, medical condition, and treatment history.

2 initial treatment phase

The study involves treatment for a staphylococcal prosthetic joint infection using the DAIR strategy, which includes debridement, antibiotics, and implant retention.

Participants are randomly assigned to receive either rifabutin or rifampicin as part of their treatment. Both medications are administered orally in the form of hard capsules.

3 medication administration

The medication regimen involves taking rifabutin or rifampicin for a duration of 12 weeks. The specific dosage and frequency are determined by the study protocol and are communicated to participants at the start of the treatment.

4 monitoring and follow-up

Participants are monitored for any adverse events or side effects throughout the 12-week treatment period. Regular follow-up appointments are scheduled to assess the effectiveness of the treatment and to ensure participant safety.

Participants are required to maintain a daily record of their medication intake in a provided notebook to track adherence.

5 evaluation of outcomes

The primary outcome is assessed after one year of follow-up, focusing on treatment success or failure. This includes evaluating the need for further surgical procedures, any infection-related deaths, or the necessity for additional antibiotic therapy.

Secondary outcomes include the occurrence of serious adverse events, changes in liver and kidney function, digestive symptoms, and any required modifications to the antibiotic dosage.

6 long-term follow-up

Participants’ quality of life and joint function are evaluated at multiple intervals: week 6, month 6, month 12, and month 24. This is done using standardized questionnaires and scoring systems.

The long-term efficacy of the treatment is assessed up to 24 months after the initial surgery to determine any late treatment failures.

Who Can Join the Study?

The patient must have a hip or knee prosthetic joint infection. This means an infection in an artificial joint.
The infection must be treated with a method called DAIR strategy, which involves cleaning the infected area, starting antibiotics, and keeping the prosthetic joint in place.
The infection must be caused by a type of bacteria called staphylococcus aureus or coagulase-negative staphylococcus aureus. These bacteria must be found in reliable samples, such as during surgery, joint fluid, or blood tests.
The bacteria must be treatable with a medicine called rifampicin and at least one other antibiotic, regardless of whether they are resistant to a drug called methicillin.
The patient must be 18 years or older.
The patient must have received at least 2 days of appropriate antibiotics that target the bacteria found in the samples taken during surgery.
The patient must sign an informed consent form, which means they agree to participate in the study after understanding what it involves.
The patient must have French social insurance.
Women who can have children must use an effective contraceptive method, such as a vasectomy for men, a copper intrauterine device, female sterilization, condoms, or sexual abstinence. A woman is considered postmenopausal if she has not had a period for 12 months without another medical reason.

Who Cannot Join the Study?

Patients who are not adults cannot participate.
Patients who do not have a staphylococcal prosthetic joint infection cannot participate.
Patients who are not being treated with the DAIR strategy cannot participate. The DAIR strategy involves cleaning the infected area, using antibiotics, and keeping the joint implant in place.
Patients with infections caused by bacteria other than staphylococci cannot participate. Staphylococci are a type of bacteria that can cause infections.
Patients who are not able to take oral medications cannot participate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may need special protection, like children or people with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
CHU Grenoble Alpes	La Tronche	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Groupe Hospitalier Du Sud Ile De France	Melun	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire De Nice	Nice	France
Hopital Beaujon	Clichy	France
Centre Hospitalier De Tourcoing	Tourcoing	France
Centre Hospitalier Bethune Beuvry	Beuvry	France
Cjmllg Hsrzkaouiqk Dxvmkshqruruh Vkjuhx	La Roche sur Yon	France
Cittkw Hwjavnqzxph Ulczrvxouimyh Dm Cjfy Nvqmtspwc	Caen	France
Agtpvdqbmc Ptzcxpfd Hzxabytg Dg Mqtjtlksf	Marseille	France
Comyyy Hhqfoglffhf Rxwqrdzy Unnrwfkzwiibc Dn Tppad	Tours	France
Cgdfqm Hqybegdetoi Unujslxixaade Avyzvm Pjqhjzms	Amiens	France
Cyxest Hhkmarwhybd Ufwwspmcttpmf Dp Rfgywi	Rennes	France
Curvri Hrqpiopvoqg Uxdrzynlxjcqz Do Nllof	Nimes	France
Cdvrmt Hrcubzsndfe Ljlr Stw	Pierre Benite	France
Ctukad Hojshuzjgne Ricenfur Diiqwmeqzibowf	Angers	France
Hmxmqtyk Udoqjhfgtlgmng Shwqklaprr &lztmcq Hycmchd dj Hjwcsocghxh	STRASBOURG, Alsace	France
Cuokzm Hhkpyjwvxum Dz Cgrdst	Colmar	France
Cptyop Hrfzchllvmu Da Pblshkbdo	Perpignan	France
Cntbya Hivptoidkve Rwrkkfve Upkdpvxtqeufd	Besançon	France
Cbccck Howvykrleae Ifvkkayzrnrxr De Cekconxetle	Quimper	France
Hcl Seyzob Abxf	Toulon	France
Hdg Nzdl	Lille	France
Ihsvjagp dp Chlebnqnitms Hvicgaozqke Uooptvhtjfasq ds Sjboj Etsvfyd (cmkuerp	Saint Priest En Jarez	France
Cpt dolopeomyggzjs	Epagny Metz Tessy	France
Ctvxvy Hoxivpfxuqx Aoyaj Ltcty	74130	France
Ggbepbwswj Drz Hjgqitol Dy Lkzarpdfwyswkwwk Ckkxdjbvkv Dz Lvyig	Lomme	France
Cwmemf Hsikivuguaf Ei Uedbmlzpiyynw Dn Lbimprp	Limoges	France
Cymotm Hnzcsckmfeh Umraufjgesbct Db Dttsc	Dijon	France
Ctnpfx Heymrmvuagz Ujbtpgwazclwr Reuxj	Reims	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	08.11.2021

Trial locations

Investigated Drugs:

Rifabutin is an antibiotic used in this trial to treat infections caused by staphylococci bacteria in prosthetic joints. It is being tested to see if it is as effective as another antibiotic, rifampicin, in managing these infections when used as part of a specific treatment strategy called DAIR, which involves cleaning the infected area, using antibiotics, and keeping the implant in place.

Rifampicin is another antibiotic used in the trial for treating staphylococcal infections in prosthetic joints. It is a well-known medication for this type of infection, and the trial aims to compare its effectiveness with rifabutin to see if rifabutin can be a suitable alternative.

Staphylococcal Prosthetic Joint Infection – This condition occurs when bacteria, specifically staphylococci such as Staphylococcus aureus or coagulase-negative staphylococci, infect a joint that has been replaced with a prosthetic implant. The infection can lead to inflammation and pain in the affected joint, often causing swelling and redness. Over time, the infection may compromise the stability and function of the joint, potentially leading to loosening of the implant. The condition is typically managed through a combination of surgical and antibiotic strategies, such as the debridement, antibiotics, and implant retention (DAIR) approach. The progression of the infection can vary, with some cases resolving with treatment while others may require further surgical intervention.

Trial ID:

2024-519894-20-01

Protocol code:

RIPH_2019_01

NCT ID:

NCT04672525

Trial Phase:

Therapeutic confirmatory (Phase III)

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