Are there any evidence supporting the use of rifampin in osteomyelitis?

Comment by InpharmD Researcher

Older studies show adjunctive rifampin can be successful for treating osteomyelitis, with a pharmacokinetic study showing adequate osteo-articular penetration. While more recent data are lacking, a 2019 retrospective study found a lower incidence of composite mortality or amputation with rifampin use for diabetic foot osteomyelitis among Veterans, and an ongoing RCT (VA INTREPID) comparing adjunctive rifampin 600 mg daily versus placebo plus antibiotics for diabetic foot osteomyelitis may help clarify its role in therapy.

Background

Guidelines from the Infectious Diseases Society of America (IDSA) recommend oral rifampin plus a fluoroquinolone as a second-line option for native vertebral osteomyelitis (NVO) caused by Staphylococci (drug susceptible or resistant). This recommended regimen is levofloxacin PO 500-750 mg q24h plus rifampin PO 600 mg q24h for 6 weeks. Rifampin plus doxycycline (for at least 3 months) has also been shown to be successful for treating Brucellar NVO. [1]

A 2024 systematic review and meta-analysis evaluated the efficacy and safety of rifampin-based therapy in patients with Staphylococcus aureus native vertebral osteomyelitis (NVO) using 13 studies (N= 679). Two randomized controlled trials were included and the rest were observational cohort studies. Rifampin-based regimens were associated with a reduced risk of clinical failure compared to standard therapy (risk difference, -14%; 95% CI, -19% to -8%; p<0.001; relative risk, 0.58; 95% CI, 0.37 to 0.92; p= 0.02). Subgroup analysis did not reveal significant differences based on methicillin resistance, but an exploratory analysis suggested a lower risk of failure in cases where rifampin was combined with fluoroquinolones. However, significant limitations, including high or unclear risk of bias across all studies and very low certainty in evidence, preclude definitive conclusions. Only one study reported adverse events, limiting safety assessments. The findings highlight the potential benefit of adjunctive rifampin in S. aureus NVO treatment, but randomized trials are needed to substantiate these observations. [2]

Research from the 1980s demonstrated enhanced osteomyelitis cure rates when vancomycin was combined with rifampin as opposed to vancomycin alone. This prompted clinical trials comparing nafcillin alone to nafcillin with rifampin for chronic Staphylococcus aureus osteomyelitis, with the combination showing higher cure rates. Similar results were observed in trials where oxacillin or vancomycin combined with rifampin led to fewer clinical failures compared to placebo in S. aureus infections. Spurring interest in rifampin as an adjunct for bone and joint infections, subsequent retrospective and randomized controlled trials found improved treatment outcomes in osteomyelitis using oral rifampin combinations compared to traditional intravenous therapies. Combinations included rifampin with trimethoprim-sulfamethoxazole, linezolid, clindamycin, and fluoroquinolones. A small trial with orthopedic device-associated staphylococcal infections showed superior outcomes with ciprofloxacin plus rifampin over ciprofloxacin alone. However, evidence supporting rifampin's benefit for osteomyelitis without prosthetic involvement is less conclusive. While a retrospective study indicated higher rifampin use in cured S. aureus vertebral osteomyelitis cases, another review found similar cure rates with or without rifampin in oral regimens. Although adding rifampin to fluoroquinolones for S. aureus osteomyelitis appears beneficial due to poor outcomes with fluoroquinolone monotherapy, the general value of rifampin adjunct therapy in non-prosthetic osteomyelitis remains unclear. An ongoing study (VA INTREPID; NCT03012529) aims to clarify rifampin's role in diabetic foot osteomyelitis without prosthetic infections; this randomized, double-blind, placebo-controlled trial is estimated to be completed by the end of September 2025. It will compare adjunctive rifampin 600 mg daily versus placebo added to backbone antibacterial therapy for 6 weeks. [3], [4]

References:

[1] Berbari EF, Kanj SS, Kowalski TJ, et al. 2015 Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for the Diagnosis and Treatment of Native Vertebral Osteomyelitis in Adults. Clin Infect Dis. 2015;61(6):e26-e46. doi:10.1093/cid/civ482
[2] El Zein S, Berbari EF, Passerini M, et al. Rifampin Based Therapy for Patients With Staphylococcus aureus Native Vertebral Osteomyelitis: A Systematic Review and Meta-analysis. Clin Infect Dis. 2024;78(1):40-47. doi:10.1093/cid/ciad560
[3] Cortés-Penfield NW, Kulkarni PA. The History of Antibiotic Treatment of Osteomyelitis. Open Forum Infect Dis. 2019;6(5):ofz181. Published 2019 Apr 8. doi:10.1093/ofid/ofz181
[4] ClincialTrials.gov. Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics (VA INTREPID). Updated November 14, 2024. Accessed March 16, 2025. https://clinicaltrials.gov/study/NCT03012529

Literature Review

A search of the published medical literature revealed 3 studies investigating the researchable question:

Are there any evidence supporting the use of rifampin in osteomyelitis?

Level of evidence

B - One high-quality study or multiple studies with limitations  Read more→



Please see Tables 1-3 for your response.


 

Adjunctive Rifampin Therapy For Diabetic Foot Osteomyelitis in the Veterans Health Administration
Design

Retrospective, observational, cohort study

N= 6,174

Objective

To compare the clinical outcomes of patients treated for diabetic foot osteomyelitis in the Veterans Health Administration with and without adjunctive rifampin

Study Groups

Rifampin-treated (n= 130)

Non-rifampin-treated (n= 6,044)

Inclusion Criteria

Patients alive and without high-level amputation at 90 days after diagnosis, treated with systemic antibiotics within 6 weeks of diagnosis

Exclusion Criteria

Patients with death or major amputation within 90 days of diagnosis, not treated with systemic antibiotics within 6 weeks, treated at facilities where rifampin was not dispensed, <14 days of rifampin, rifampin started >42 days after diagnosis

Methods

Data were extracted from VHA databases of patients initiating rifampin therapy within 6 weeks of diabetic foot osteomyelitis diagnosis; patients receiving the drug for at least 14 days within 90 days were considered treated with rifampin. Patients not administered rifampin within 90 days served as the comparator group. 

Duration

January 1, 2009, through December 31, 2013

Outcome Measures

Primary: Combined end point of mortality or amputation within 2 years of diagnosis

Baseline Characteristics  

Rifampin (n= 130)

Non-rifampin (n= 6,044)

Age, years

62.2 ± 9.4

64.9 ± 9.6
Male

100%

98.5%

Charlson comorbidity index score

3.5 ± 1.8 4.0 ± 2.2

Infectious disease consultation

48.5% 32.4%

Staphylococcus aureus identified

42.3% 29%
Results  

Rifampin (n= 130)

Non-rifampin (n= 6,044) p-value

Amputation or death after 2 years

Amputation

Death

35 (26.9%)

17.7%

10.8%

2250 (37.2%)

23%

17.5%

0.02

0.19

0.06

Logistic regression analysis, adjusting for confounding variables such as age, comorbidities, and microbiological findings, demonstrated a statistically significant association between rifampin use and improved amputation-free survival (odds ratio, 0.65; 95% CI, 0.43 to 0.96; p= 0.04).

Additionally, significant associations were seen with A1c and serum creatinine levels and amputation-free survival, suggesting a role of glycemic control and renal function on outcomes. 

Adverse Events

Not studied

Study Author Conclusions

Patients administered rifampin experienced lower rates of death and amputation than those not treated with rifampin, suggesting that adjunctive rifampin may be a useful antimicrobial option in the treatment of diabetic foot osteomyelitis.

Critique

The study's observational design and reliance on administrative data may introduce biases and limit causal inferences. The varied antibiotic regimens (which were not reported) and lack of data on non-VHA dispensed antibiotics and nonpharmacological interventions introduce a higher possibility of confounding. However, the large sample size and use of multivariable logistic regression to adjust for confounders are strengths.

 

References:

Wilson BM, Bessesen MT, Doros G, et al. Adjunctive Rifampin Therapy For Diabetic Foot Osteomyelitis in the Veterans Health Administration. JAMA Netw Open. 2019;2(11):e1916003. doi:10.1001/jamanetworkopen.2019.16003

 

Long-Term Follow-Up Trial of Oral Rifampin-Cotrimoxazole Combination versus Intravenous Cloxacillin in Treatment of Chronic Staphylococcal Osteomyelitis

Design

Randomized clinical trial

N= 50

Objective

To compare the efficacy of an 8-week oral rifampin-cotrimoxazole (trimethoprim-sulfamethoxazole; Bactrim) treatment with a 6-week intravenous cloxacillin treatment (plus 2-week oral) in patients with chronic Staphylococcus aureus osteomyelitis

Study Groups

Cloxacillin (n= 22)

Rifampin-Bactrim (n= 28)

Inclusion Criteria

Patients who had undergone surgery for chronic nonaxial osteomyelitis due to S. aureus, with or without associated foreign bodies, from 1991 to 1996

Exclusion Criteria

Patients with prosthetic joint infections, polymicrobial infections, or infections with cloxacillin-, Bactrim-, or rifampin-resistant isolates

Methods

Patients were randomized to receive either intravenous cloxacillin (2 g every 4 hours) for 6 weeks plus oral cloxacillin (500 mg every 6 hours) for 2 weeks (Group A) or oral rifampin-Bactrim (600 mg rifampin daily plus 7-8 mg/kg/day of trimethoprim component) for 8 weeks (Group B). Additional folinic acid was given at the physician's discretion. Treatment compliance was monitored, and follow-up was conducted for 10 years.

Duration

Follow-up period: 10 years

Outcome Measures

Primary: Cure rate (remission of symptoms and absence of failure during follow-up)

Secondary: Treatment tolerability, length of hospital stay

Baseline Characteristics  

Cloxacillin (n= 22)

Rifampin-Bactrim (n= 28) p-value

Age, years

47.7 ± 18.3 41.7 ± 21.1 0.29

Male

17 (77.3%) 21 (75.0%) 0.85
Underlying conditions 8 (36.4%)

6 (21.4%)

0.34

Source of infection

Postsurgical

Hematogenous

Secondary to trauma

Secondary to contiguous focus

 

18 (81.8%)

3 (13.6%)

1 (4.5%)

0

 

16 (57.1%)

6 (21.4%)

3 (10.7%)

3 (10.7%)

0.27

Infection location

Femur

Tibia

Humerus

Small bones (hand, foot, or patella)

 

9 (40.9%)

7 (31.8%)

3 (13.6%)

3 (13.6%)

 

8 (28.6%)

9 (32.1%)

2 (7.1%)

9 (32.1%)

0.41

Median duration of symptoms, months (IQR)

5 (2-16) 3 (1-10) 0.25

Temp ≥38°C

6 (27.3%) 4 (14.3%) 0.43

Orthopedic implants (not prosthesis)

10 (45.2%) 10 (35.7%) 0.49
IQR: interquartile range
Results  

Cloxacillin (n= 22)

Rifampin-Bactrim (n= 28) p-value

Median length of hospital stay, days (IQR)

51 (43-67) 31 (21-49) 0.002

Cured by intention to treat

Cured per protocol

19/21 (90.5%)

17/18 (94.4%)

24/27 (88.9%)

22/24 (91.7%)

1.00

1.00

Adverse Events

In group A, three (13.6%) had phlebitis. In group B, three (10.7%) had a skin rash, one (3.6%) had a bronchospasm, and one (3.6%) had vomiting.

Study Author Conclusions

Oral rifampin plus sulfamethoxazole-trimethoprim therapy is a viable alternative to intravenous cloxacillin for chronic staphylococcal osteomyelitis, offering similar efficacy with the advantage of a shorter hospital stay. Foreign body maintenance is a significant risk factor for relapse.

Critique

The study's strengths include its long-term follow-up and the comparison of oral and intravenous therapies. However, the small sample size limits the statistical power, and the single-center design may affect the generalizability of the findings. The study also highlights the challenge of managing foreign body-associated infections, which remain a significant risk factor for relapse.

 

References:

Euba G, Murillo O, Fernández-Sabé N, et al. Long-term follow-up trial of oral rifampin-cotrimoxazole combination versus intravenous cloxacillin in treatment of chronic staphylococcal osteomyelitis. Antimicrob Agents Chemother. 2009;53(6):2672-2676. doi:10.1128/AAC.01504-08

 

Rifampicin in the treatment of osteoarticular infections due to staphylococci

Design

Pharmacokinetic study

N= 68

Objective

To evaluate the effectiveness of rifampin (rifampicin) in treating staphylococcal bone and articular infections, focusing on its tissue diffusion and clinical outcomes

Study Groups

Group 1: 300 mg single dose (n=10)

Group 2: 300 mg q12h x 2 (n=8)

Group 3: 300 mg q12h x 2 (n=11)

Group 4: 600 mg single dose (n=7)

Group 5: 600 mg daily x 2 (n=10)

Group 6: 600 mg daily x 3 (n=4)

Group 7: 600 mg daily x 1 or 2 (n=7)

Group 8: 600 mg single dose (n=11)

Inclusion Criteria

Patients with osteoarthritis of the hip requiring total prosthesis

Exclusion Criteria

Not specified

Methods

Patients were divided into groups based on rifampin dosage (300 or 600 mg), schedule (single dose, once daily, q12h) and sampling time (3-4 h, 12-14 h, or 24-26 h post-dose). Serum and bone concentrations were measured at different intervals after administration. Rifampin was used in combination with other antibiotics for treating infections.

Duration

January 1978 to December 1981

Outcome Measures

Primary: Serum and bone concentrations of rifampin

Secondary: Clinical efficacy in treating staphylococcal infections

Baseline Characteristics Not reported
Results Regimen Sample time, h after last dose

Rifampin Concentration

Serum, mg/L

Cancellous bone (mcg/g)

Cortical bone (mcg/g)

300 mg (n= 10) 3 2.8 ± 0.5 0.5 ± 0.2 0
300 mg q12h (n= 8) 3 6.0 ± 2.6 1.2 ± 0.5 0
300 mg q12h (n= 11) 12 0.9 ± 0.4 0.2 ± 0.1 0
600 mg daily (n= 21) 3 7.8 ± 1.4 2.9 ± 0.6 1.2 ± 0.6
600 mg daily (n= 7) 12 2.3 ± 1.0 0.9 ± 0.4 0-0.08
600 mg single dose (n= 11) 24 0.07 ± 0.07 0-0.06 0

The cancellous bone-to-serum ratio was 0.41 at 3 hours and 0.39 at 12 hours, highlighting substantial bone penetration.

 

The clinical efficacy of rifampin was assessed in 20 hospitalized patients with staphylococcal septic arthritis, treated using rifampin in combination with other antibiotics such as cloxacillin, pristinamycin, or trimethoprim-sulfamethoxazole. Initial therapy included intravenous methicillin and aminoglycosides for an average of 24 days, followed by oral rifampin-based regimens for a mean duration of 62 days.

After a 24-month follow-up, all infections resolved without relapse, although 20% developed anatomical sequelae and 16% exhibited functional impairment.

Adverse Events

Two side-effects necessitated discontinuation: one cutaneous allergy and one gastro-intestinal disturbance with nausea, vomiting, and slightly raised transaminase levels.

Study Author Conclusions

Rifampin plays an essential role in the treatment of septic arthritis and osteo-articular infections due to its high bone tissue diffusion and satisfactory clinical and biological tolerance.

Critique

The study provides valuable insights into the use of rifampin for osteoarticular infections, highlighting its effective tissue penetration and clinical outcomes. However, the lack of a control group and the combination with other antibiotics make it difficult to isolate the specific effects of rifampin. The study's retrospective nature and small sample size further limit the generalizability of the findings. The lack of substantial baseline characteristic data, confusion among the groupings and dosing scheme, and overall older data (resistance patterns may be different to the present time) are additional limitations.

 

References:

Cluzel RA, Lopitaux R, Sirot J, Rampon S. Rifampicin in the treatment of osteoarticular infections due to staphylococci. J Antimicrob Chemother. 1984;13 Suppl C:23-29. doi:10.1093/jac/13.suppl_c.23