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Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR

NCT04672525 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 436

Last updated 2022-05-10

No results posted yet for this study

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. 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.

Conditions

  • Prosthetic Infection

Interventions

DRUG

Rifabutin

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

DRUG

Rifampicin

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

Sponsors & Collaborators

  • Tourcoing Hospital

    lead OTHER

Principal Investigators

  • Eric SENNEVILLE, Md PhD · CH TOURCOING

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-08
Primary Completion
2026-11-30
Completion
2027-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04672525 on ClinicalTrials.gov