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Prosthetic InfectionPhase 3RIFAMABNCT04672525

Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR

A Phase 3 study testing Rifabutin and Rifampicin in people with Prosthetic Infection, run by Tourcoing Hospital at 30 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Rifampicin, is key in the treatment of staphylococcal PJIs. Rifabutin has a better profile of tolerance than rifampicin regarding the risk of interaction with concomitant medications and liver disorders. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prosthetic Infection
What is being tested?
Rifabutin and Rifampicin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
436 participants
Where
30 sitesFrance
Study dates
8 Nov 2021to Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hip or knee Prosthetic joint infection treated by debridement, antibiotic therapy initiation and retention of prothesis (DAIR strategy)
  • Infected with at least one of the following microorganisms:
  • Staphylococcus aureus
  • Coagulase-negative staphylococci
  • Microorganisms susceptible to rifampicin and at least one other antibiotic suitable for the treatment of PJI (e.g., penicillin, fluoroquinolone, (doxy/mino)cycline, oxazolidinone, cotrimoxazole, daptomycin, glycopeptide, macrolide, fusidic acid), regardless of sensitivity to methicillin.
  • Age ≥ 18 years
Show all 10Show fewer
  • At least 2 days of appropriate (i.e., covering pathogen(s) identified in the intraoperative samples) empirical agents are needed. Pre-randomization antimicrobial therapy could be: flucloxacillin, oxacillin, vancomycin, daptomycin. β-lactam plus β-lactamase-inhibitors (e.g. ampicillin+sulbactam, piperacillin+tazobactam), cephalosporins (except ceftazidime), carbapenems, teicoplanin, ceftaroline, ceftobiprole.
  • Signed Inform consent
  • Patient having the rights to French social insurance
  • For women of childbearing potential i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile and excluding oestroprogestative-based contraception, any effective contraceptive: vasectomy (for men), intrauterine device copper, feminine sterilization, condom, sexual abstinence is required. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause

Who cannot join

  • Suspicion of reduce absorption of oral treatment due to abdominal disorder Known or suspected malabsorption (imperfect absorption of food material by the small intestine)
  • Polymicrobial infection due to other than staphylococcus species susceptible to rifampicin
  • Known or suspected allergy to rifabutin and/or rifampicin
  • Diagnosis of endocarditis associated to PJI
  • Renal transplant or Chronic kidney disease with an eGFR of less than 30ml/min/1.73m²
  • Other Solid Organ Transplant
Show all 17Show fewer
  • Liver cirrhosis, Child-Pugh score C
  • Any other concomitant infection which required a prolonged course of intravenous antibiotic therapy
  • Oestroprogestative-based contraception
  • Oral anticoagulant drugs
  • Other drug-drug interaction that contraindicated rifampicin or rifabutin
  • Porphyria
  • Unable to take oral treatment
  • Receive empirical postoperative antibiotic treatment by rifampicin or rifabutin prior to randomization
  • Pregnancy or lactating women
  • Curator or guardianship or patient placed under judicial protection
  • Participation in other interventional research during the study

Trial locations and contacts

30 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Eric SENNEVILLE, MD PhD contact

0320694949

esenneville@ch-tourcoing.fr

Solange TREHOUX contact

0320694280

strehoux@ch-tourcoing.fr

30 sites in 1 country

France30 sites, 30 recruiting

  • CHU Amiens Picardie

    Amiens

    Benoit BRUNSCHWEILER

    Not yet recruiting

  • CHU Angers

    Angers

    Not yet recruiting

  • CHU Besançon

    Besançon

    Kévin BOUILLER

    Recruiting

  • CH de Béthune

    Béthune

    Not yet recruiting

  • CHU Bordeaux

    Bordeaux

    Fréderic-Antoine DAUCHY

    Not yet recruiting

  • APHP Hôpital Ambroise Paré

    Boulogne-Billancourt

    Aurélien DINH

    Not yet recruiting

  • CHRU Brest

    Brest

    Severine ANSART

    Recruiting

  • CHU Caen

    Caen

    Recruiting

  • CH Alpes Leman

    Contamine-sur-Arve

    Not yet recruiting

  • CHU Dijon Bourgogne

    Dijon

    Lionel PIROTH

    Not yet recruiting

  • CHU Grenoble Alpes

    Grenoble

    Not yet recruiting

  • CHRU Lille

    Lille

    Henry MIGAUD

    Recruiting

  • GHICL Hôpital Saint Vincent de Paul

    Lille

    Not yet recruiting

  • CHU de Limoges

    Limoges

    Recruiting

  • GHICL Hôpital Saint Philibert

    Lomme

    Not yet recruiting

  • Clinique de la Sauvegarde

    Lyon

    Anne-Laure BLANC

    Not yet recruiting

  • Hospices Civils de Lyon

    Lyon

    Tristan FERRY

    Not yet recruiting

  • APHM Hôpital Nord

    Marseille

    Not yet recruiting

  • CHU Nice

    Nice

    Johan COURJON

    Not yet recruiting

  • CH Annecy Genevois

    Pringy

    Violaine TOLSMA

    Recruiting

  • CH Cornouaille

    Quimper

    Lydie KHATCHATOURIAN

    Not yet recruiting

  • CHU Reims

    Reims

    Not yet recruiting

  • CHU de Rennes

    Rennes

    Cédric ARVIEUX

    Recruiting

  • CHU Saint Etienne

    Saint-Priest-en-Jarez

    Not yet recruiting

  • CHRU Strasbourg

    Strasbourg

    Cécile RONDE-OUSTAU

    Not yet recruiting

  • Hôpital d'instruction des armées Sainte Anne

    Toulon

    Recruiting

  • Clinique Joseph Ducuing

    Toulouse

    Not yet recruiting

  • Clinique Médipole Garonne

    Toulouse

    Not yet recruiting

  • CH Tourcoing

    Tourcoing

    Eric SENNEVILLE

    Recruiting

  • CHRU Tours

    Tours

    Louis BERNARD

    Recruiting

Other trials in France

About this study

Official title: Rifabutin Versus Rifampicin for Treatment of Staphylococcal Prosthetic Joint Infection Treated With Debridement, Antibiotics and Implant Retention (DAIR Strategy): a Multicenter Randomized, Open-label, Non-inferiority Trial

Rifampicin, is key in the treatment of staphylococcal PJIs. Rifabutin has a better profile of tolerance than rifampicin regarding the risk of interaction with concomitant medications and liver disorders. The hypothesis is that rifabutin may be an alternative antibiotic option as efficient as rifampicin for the treatment of staphylococcal PJIs, with a better safety profile. The investigator aim to demonstrate the non-inferiority of rifabutin as compared with rifampicin prescribed in combination treatment for PJIs.

Being tested
Rifabutin, Rifampicin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RifabutinDrug

    2 tablets of 150 mg per day rifabutin tablet daily for 12 weeks in 1 administration with a companion treatment

  • RifampicinDrug

    10 mg/kg per day (range 600 mg to 1,200 mg) rifampicin tablet in 1 daily dose for 12 weeks with a companion treatment

Study groups in NCT04672525
Study groupRoleWhat they receive
RIFAMPICINActive comparatorPatient with staphylococcal PJI, treated with DAIR strategy, and randomized in the control group will receive rifampicin in association with another antibiotic except rifabutin, as-per recommendations for 12 weeks.
Receives: Drug: Rifampicin
RIFABUTINExperimentalPatient with staphylococcal PJI treated with DAIR strategy, and randomized in the experimental group, will receive rifabutin in association with another antibiotic except rifampicin, as-per recommendations for 12 weeks.
Receives: Drug: Rifabutin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment failure

    Treatment failure defined as one of following events:

    • The need for any further surgical procedure - i.e. implants removal, implants exchange or amputation;
    • And/or PJI related death;
    • And/or use of suppressive antibiotic therapy that was not planned before randomization

    Measured: At one year

Secondary outcomes (7)

  1. Occurrence of serious adverse events (SAEs), including death (i.e. all cause)

    Proportion of patient which are free from SAEs occurrence, as defined by:

    -Patients who completed the entire 12 weeks duration of antibiotic treatment planned initially and; xWho did not experience grade 3-4 adverse events, including death, regardless of the link with antibiotic therapy; xWho did not experience adverse events which led to either to:

    • Reduce the dosage or split the treatment to two take/day;
    • Or stop any component of the antibiotic treatment.

    Measured: At the end of 12 weeks duration of antibiotic treatment planned

  2. Occurrence of any adverse event that could be related to rifampicin or rifabutin

    Number and rate of patients in each arm who experiences:

    • Liver cytolysis (>=2N for ALT AND/OR AST)
    • Acute Kidney failure as defined by serum creatinine increase in KDIGO
    • Digestive symptoms, including diarrhea
    • Who required a modification of antibiotic dosage during the 12 weeks' period of antibiotic treatment
    • Uveitis/ophthalmologic disorder
    • Neurological disorder

    Measured: At the end of 12 weeks duration of antibiotic treatment planned

  3. Proportion of patients from each arm who will complete the 12-week duration of rifampicin/rifabutin treatment, early termination of the planned 12 weeks' period of antibiotics

    Early termination rate will be measured in each arm, as the number of patients having stopped rifampicin or rifabutin before the planned 12 weeks period over the total number of patients enrolled in the studied arm.

    Measured: At the end of 12 weeks duration of antibiotic treatment planned

  4. Adherence to antibiotics regimen

    Adherence rate to medication will be measured as the number of days on which all doses were missed over the number of days of planned antibiotic therapy. Patients enrolled in the study will have to fill their pill count in a daily notebook.

    Measured: At the end of 12 weeks duration of antibiotic treatment planned

  5. Quality of life, as evaluated by EQ 5D 3L questionnaire

    Quality of life, as evaluated by the use EQ 5D 3L auto-questionnaire as used in previous randomized clinical trial on bone and joint infection

    Measured: At the end of the study follow up, an average of 24 months

  6. Functional prognosis using Oxford questionnaire evolution according to location of PJI

    Oxford Scores as used in previous randomized clinical trial on bone and joint infection

    Measured: At the end of the study follow up, an average of 24 months

  7. Long term efficacy of rifampicin and rifabutin treatment

    Long term efficacy: treatment failure, as defined for primary outcome, at 24 months

    Measured: At the end of the study follow up, an average of 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start8 Nov 2021
  3. Primary completionNov 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
436 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04672525
Sponsor's protocol ID
RIPH_2019_01
Acronym
RIFAMAB
Status last verified
May 2022
First submitted
11 Oct 2020
Last updated
10 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rifabutin and Rifampicin in people with Prosthetic Infection, run by Tourcoing Hospital at 30 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eric SENNEVILLE, MD PhD (0320694949, esenneville@ch-tourcoing.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment failure (time frame: At one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04672525.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.

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