Three Weeks Versus Six Weeks of Antibiotic Therapy for Diabetic Foot Osteomyelitis: A Prospective, Randomized, Noninferiority Pilot Trial.
Clin Infect Dis
; 73(7): e1539-e1545, 2021 10 05.
Article
em En
| MEDLINE
| ID: mdl-33242083
ABSTRACT
BACKGROUND:
In patients with diabetic foot osteomyelitis (DFO) who underwent surgical debridement, we investigated whether a short (3 weeks) duration compared with a long (6 weeks) duration of systemic antibiotic treatment is associated with noninferior results for clinical remission and adverse events (AEs).METHODS:
In this prospective, randomized, noninferiority pilot trial, we randomized (allocation 11) patients with DFO after surgical debridement to either a 3-week or a 6-week course of antibiotic therapy. The minimal duration of follow-up after the end of therapy was 2 months. We compared outcomes using Cox regression and noninferiority analyses (25% margin, power 80%).RESULTS:
Among 93 enrolled patients (18% females; median age 65 years), 44 were randomized to the 3-week arm and 49 to the 6-week arm. The median number of surgical debridements was 1 (range, 0-2 interventions). In the intention-to-treat (ITT) population, remission occurred in 37 (84%) of the patients in the 3-week arm compared with 36 (73%) in the 6-week arm (Pâ =â .21). The number of AEs was similar in the 2 study arms (17/44 vs 16/49; Pâ =â .51), as were the remission incidences in the per-protocol (PP) population (33/39 vs 32/43; Pâ =â .26). In multivariate analysis, treatment with the shorter antibiotic course was not significantly associated with remission (ITT population hazard ratio [HR], 1.1 [95% confidence interval {CI}, .6-1.7]; PP population HR, 0.8 [95% CI .5-1.4]).CONCLUSIONS:
In this randomized controlled pilot trial, a postdebridement systemic antibiotic therapy course for DFO of 3 weeks gave similar (and statistically noninferior) incidences of remission and AE to a course of 6 weeks. CLINICAL TRIALS REGISTRATION NCT03615807; BASEC 2016-01008 (Switzerland).Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Osteomielite
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Pé Diabético
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Diabetes Mellitus
Tipo de estudo:
Clinical_trials
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Guideline
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Observational_studies
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Risk_factors_studies
Limite:
Aged
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Female
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Humans
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Male
Idioma:
En
Revista:
Clin Infect Dis
Assunto da revista:
DOENCAS TRANSMISSIVEIS
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Suíça