a Service des Maladies Infectieuses et Tropicales , b Service d'Endocrinologie, c Service d'Orthopédie-Traumatologie and d Laboratoire de Microbiologie, Hôpital Dron, 135 rue du Pr Coty, F-59200 Tourcoing; e Service de Médecine Nucléaire Hôpital Victor Provo, F-59100 Roubaix, France
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Abstract |
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Introduction |
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Materials and methods |
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Study patients received ofloxacin 200 mg po tds with food and rifampicin 600 mg po bd 30 min before or 2 h after food. Antibiotic dosages and duration were adapted from the French guidelines for treating chronic osteomyelitis.3 High doses of ofloxacin (i.e. 400 mg bd) were not used because they are not always tolerated by the elderly. We used a tds regimen to avoid the low blood levels observed in some patients due to inter-individual differences in fluoroquinolone metabolism.4 Initial iv administration of the study treatment was accepted. After 3 months of treatment, patients with a satisfactory clinical and radionuclide evaluation were permitted to stop the treatment, although they were encouraged to complete 6 months of treatment.
The primary outcome of the study was clinical response defined as cure (disappearance of all signs and symptoms associated with the initial ulcer at the end of the treatment and no relapse occurring during the post-treatment follow-up period) or failure (any other outcome). Relapse and superinfection were defined as appearance of an active infection at the site of the initial infection or contiguous to it due to a pathogen identical to or different from the pathogen isolated at enrolment in the study, respectively. Bone scan assessment was graded as: significant improvement or normalization of the bone uptake, no improvement or deterioration. After hospital discharge, patients were followed up at 3 and 6 months by the infectious diseases consultant and monthly by the endocrinologist.
Patients with infections caused by pathogens resistant to rifampicin or ofloxacin were excluded from the study.
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Results and discussion |
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The median age of the study patients was 62 years (range 5177 years) and 13 (76.5%) were male; all patients had non-insulin-dependent diabetes mellitus with a median duration of 16 years (range 930 years). Most foot lesions (15/20) were graded with a Wagner score of 3 (Table 1). Only one patient had fever at entry (patient 9). Fifteen patients underwent plain radiographs of the foot, among which 12 were abnormal, showing bone demineralization in 10 cases and a cortical defect in two cases.
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At entry, coupled galliumtechnetium bone scan performed in four patients and Sulesomabtechnetium performed in the 13 remaining patients showed marked bone uptake consistent with the diagnosis of osteomyelitis. The overall number of improved or normalized bone scans at the end of treatment was 16/17 (94%). Clinical and scintigraphic assessment of the osteomyelitis outcome was concordant in 16 of the 17 episodes for which the comparison was feasible. No adverse events were reported in the 13 patients who underwent repeated Sulesomab scintigraphies.
Fifteen adverse effects, predominantly gastrointestinal and neurological, were reported in nine patients (47%), related to rifampicin and ofloxacin respectively, but did not require the discontinuation of the study treatment. Rifampicin dosage was reduced by 50% in four patients because of nausea. Three patients (3, 7 and 10) died of causes unrelated to the foot infection during the study. The isolation of multi-resistant bacteria in four patients might be the result of prolonged antibiotic therapy and could argue for shorter courses of treatment such as 3 months or less.9
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Notes |
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References |
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2 . Harwood, S. J., Valdivia, S., Hung, G.-L. & Quenzer, R. W. (1999). Use of Sulesomab, a radiolabeled antibody fragment to detect osteomyelitis in diabetic patients with foot ulcers by leukoscintigraphy. Clinical Infectious Diseases 28, 12005.[ISI][Medline]
3 . Conférence de Consensus en Thérapeutique Anti-Infectieuse. (1991). Les infections bactériennes ostéo-articulaires en dehors des infections à mycobactéries. Semaine des Hôpitaux de Paris 30, 138995.
4 . Kuck, E. M., Bouter, K. P., Hoekstra, J. B. L., Connemans, J. M. H. & Diepersloot, J. A. (1998). Tissue concentrations after a single-dose orally administered ofloxacin in patients with diabetic foot infections. Foot and Ankle International 19, 3840.[Medline]
5 . Nordern, D. W. (1988). Lessons learned from animal models of osteomyelitis. Reviews of Infectious Diseases 10, 10310.[ISI][Medline]
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Pittet, D., Wyssa, B., Herter-Clavel, C., Kursteiner, K., Vaucher, J. & Lew, D. (1999). Outcome of diabetic foot infections treated conservatively. Archives of Internal Medicine 159, 8516.
7 . Venkatesan, P., Lawn, S., Macfarlane, R. M., Fletcher, E. M., Finch, R. G. & Jeffcoate, W. J. (1997). Conservative management of osteomyelitis in the feet of diabetic patients. Diabetic Medicine 14, 48790.[ISI][Medline]
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Lew, D. P. & Waldvogel, F. A. (1997). Osteomyelitis. New England Journal of Medicine 336, 9991007.
9 . Lipsky, B. A. (1999). Evidence-based antibiotic therapy of diabetic foot infections. FEMS Immunology and Medical Microbiology 26, 26776.[ISI][Medline]
Received 20 April 2001; returned 25 June 2001; revised 6 August 2001; accepted 15 August 2001