Table 1:

Prospective RCTs of Osteomyelitis

Author	Year	N	Inclusion & Exclusion*	Regimen Oral vs IV	Success† Oral vs IV	Complications Oral vs IV, n (%)
Greenberg22	‘87	30	Included: positive bacterial cultures (blood or bone) Excluded: malignant otitis externa, severity of disease requiring IV therapy	Ciprofloxacin vs. standard IV	50% (7/14) vs. 69% (11/16)	Relapse AEs	4 (28%) vs. 1 (6%) 2 (14%) vs. 6 (38%)
Gentry17	‘90	59	Included: debrided OM Excluded: septicemia, MRSA	Ciprofloxacin vs. βL+AG	77% (24/31) vs. 79% (22/28)	Relapse AEs	6 (19%) vs. 5 (18%) 1 (3%) vs. 4 (14%)
Mader16	’90	26	Included: extra-axial OM with debridement and culture Excluded: severe renal or hepatic disease, antibiotics within 3 days	Ciprofloxacin vs. βL/clindamycin+AG	79% (11/14) vs. 83% (10/12)	AEs	7 (37%) vs. 4 (29%)
Gentry20	‘91	33	Included: biopsy confirmed OM Excluded: multiple sites of infection, retained prosthetic material, bacteremia	Ofloxacin vs. cephalosporin	74% (14/19) vs. 86% (12/14)	Relapse AEs	6 (19%) vs. 5 (18%) 7 (37%) vs. 4 (29%)
Gomis21	‘99	32	Included: debrided chronic OM (extra-axial, sacral), 1 PJI	Ofloxacin vs. imipenem	69% (11/16) vs. 50% (8/16)‡	Serious AEs	0 (0%) vs. 3 (19%)
Schrenzel14	‘04	39	Included: S. aureus bone and joint infection Excluded: chronic OM without debridement, retained foreign bodies, antimicrobials given >72 hours before enrollment	Fleroxacin + rifampin vs. βL/vancomycin	82% (18/22) vs. 65% (11/17)	Death AEsϕ	3 (4.4%) vs. 5 (8.5%) 15 (22%) vs. 5 (8%)
Euba18	‘09	48	Included: surgical debridement for chronic extra-axial OM with or without foreign body Excluded: PJI, polymicrobial	TMP-SMX + rifampin vs. cloxacillin	89% (24/27) vs. 91% (19/21)‡	Relapse AEs	3 (11%) vs. 2 (10%) 5 (18%) vs. 3 (14%)
Li15	’19	1054	Included: extra-axial or vertebral OM, septic arthritis, PJI, fixation device infection	standard oral vs. standard IV	87% (457/527) vs. 85% (450/527)‡	Early discontinuation due to relapse Serious AE’s	15 (3%) vs. 1 (0.1%) 138 (26%) vs. 147 (28%)
Totals (N=8 RCTs)		1321		Oral: 84% (566/670) vs. IV: 83% (543/651)

^*All studies excluded children, pregnancy, and patients with organisms resistant to study drug.

^†Success = absence of osteomyelitis at long term follow-up (most studies >1 year). AE: adverse events; AG: aminoglycoside; βL: beta-lactam; OM: osteomyelitis; PJI = prosthetic joint infection; standard: standard of care, within protocol specifications; TMP-SMX: trimethoprim-sulfamethoxazole;

^‡Outcomes by intention-to-treat;

^ϕThis study performed a subgroup analysis to determine treatment success, but AEs for the full study population regardless of site of infection, so the AE numbers are for the larger population from the study.