Patients Response to Early Switch To Oral:Osteomyelitis Study

• Status: Terminated
• Trial end date: 2018-11-07
• Target enrollment: 0
• Participant gender: All

Summary

Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics.

The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Julio Ramirez
• Collaborators: James Graham Brown Cancer Center; University of Louisville
• Treatments: Amikacin; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Azithromycin; Aztreonam; Bacampicillin; Bacitracin; Benzathine benzylpenicillin, procaine benzylpenicillin, drug combination; Benzoyl Peroxide; Capreomycin; Carbenicillin; Carbenicillin indanyl; Cefaclor; Cefamandole; Cefamandole nafate; Cefdinir; Cefepime; Cefixime; Cefmetazole; Cefonicid; Cefoperazone; Cefotaxime; Cefotetan; Cefoxitin; Cefpodoxime; Cefpodoxime proxetil; Cefprozil; Ceftazidime; Ceftibuten; Ceftizoxime; Ceftriaxone; Cefuroxime; Cefuroxime axetil; Cephalosporins; Chloramphenicol; Chloramphenicol succinate; Chlortetracycline; Cilastatin; Cilastatin, Imipenem Drug Combination; Cinoxacin; Ciprofloxacin; Clarithromycin; Clavulanic Acid; Clavulanic Acids; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Cloxacillin; Colistin; Cycloserine; Dalfopristin; Demeclocycline; Dicloxacillin; Dirithromycin; Doxycycline; Enoxacin; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Ethionamide; Fluoroquinolones; Fosfomycin; Gatifloxacin; Gentamicins; Grepafloxacin; Imipenem; Isoniazid; Kanamycin; Levofloxacin; Lincomycin; Linezolid; Lomefloxacin; Loracarbef; Mafenide; Meropenem; Methacycline; Methenamine; Methenamine hippurate; Methenamine mandelate; Methicillin; Metronidazole; Mezlocillin; Minocycline; Moxifloxacin; Mupirocin; Nafcillin; Nalidixic Acid; Neomycin; Netilmicin; Nitrofurantoin; Nitrofurazone; Norfloxacin; Norgestimate, ethinyl estradiol drug combination; Novobiocin; Ofloxacin; Oxacillin; Oxytetracycline; Paromomycin; Penicillanic Acid; Penicillin G; Penicillin G Benzathine; Penicillin G Procaine; Penicillin V; Penicillins; Piperacillin; Piperacillin, Tazobactam Drug Combination; Polymyxin B; Polymyxins; Procaine; Pyrazinamide; Quinupristin-dalfopristin; Rifabutin; Rifampin; Rifapentine; Silver Sulfadiazine; Sparfloxacin; Spectinomycin; Streptomycin; Sulbactam; Sulfacetamide; Sulfadiazine; Sulfamethizole; Sulfamethoxazole; Sulfasalazine; Sulfisoxazole; Sulperazone; Sultamicillin; Tazobactam; Tetracycline; Ticarcillin; Ticarcillin-clavulanic acid; Tobramycin; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination; Vancomycin; Virginiamycin

Criteria

Inclusion Criteria:

• Only adult patients will be invited to participate in this trial (age ≥ 18 years). A patient will be considered a candidate to participate in this trial if the following two inclusion criteria are present:

1. Isolation of an organism from bone culture that is susceptible to intravenous and oral antibiotics.

2. Plus at least one of the following:

• Evidence of local inflammatory response, manifested as local pain, edema, erythema, warmth, or drainage.

• Evidence of systemic inflammatory response, manifested as fever, elevated C---reactive protein (CRP) level, erythrocyte sedimentation rate (ESR), or white blood cell count.

• *Osteomyelitis---compatible findings on plain radiograph, computed tomography, bone scan, magnetic resonance imaging, or positron emission tomography.

• Pathology report indicative of osteomyelitis.

Exclusion Criteria:

• A patient will not be considered as a candidate to participate in this study if the study team expects the subject to be non---compliant with the study follow---up clinic visit.