drugset / Trial / NCT02099240
Patients Response to Early Switch To Oral:Osteomyelitis Study
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2014-03-06
- Primary completion
- 2018-11-07
- Completion
- 2018-11-07
Publications
- Results Lew DP, Waldvogel FA. Osteomyelitis. Lancet. 2004 Jul 24-30;364(9431):369-79. doi: 10.1016/S0140-6736(04)16727-5.
- Results Haas DW, McAndrew MP. Bacterial osteomyelitis in adults: evolving considerations in diagnosis and treatment. Am J Med. 1996 Nov;101(5):550-61. doi: 10.1016/s0002-9343(96)00260-4.
- Results Waldvogel FA, Medoff G, Swartz MN. Osteomyelitis: a review of clinical features, therapeutic considerations and unusual aspects. N Engl J Med. 1970 Jan 22;282(4):198-206. doi: 10.1056/NEJM197001222820406. No abstract available.
- Results Lazzarini L, Lipsky BA, Mader JT. Antibiotic treatment of osteomyelitis: what have we learned from 30 years of clinical trials? Int J Infect Dis. 2005 May;9(3):127-38. doi: 10.1016/j.ijid.2004.09.009.
- Results Conterno LO, da Silva Filho CR. Antibiotics for treating chronic osteomyelitis in adults. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD004439. doi: 10.1002/14651858.CD004439.pub2.
- Results Peyrani P, Allen M, Seligson D, Roberts C, Chen A, Haque N, Zervos M, Wiemken T, Harting J, Christensen D, Ramirez R. Clinical outcomes of osteomyelitis patients infected with methicillin-resistant Staphylococcus aureus USA-300 strains. Am J Orthop (Belle Mead NJ). 2012 Mar;41(3):117-22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amikacin | Small molecule | — | Oral |
| Comparator | Amoxicillin | Other / unclassified | — | Oral |
| Comparator | Ampicillin | Unknown | — | Oral |
| Comparator | Azithromycin | Small molecule | — | Oral |
| Comparator | Aztreonam | Small molecule | — | Oral |
| Comparator | Bacampicillin | Small molecule | — | Oral |
| Comparator | Bacitracin | Unknown | — | Oral |
| Comparator | Benzylpenicillin | Unknown | — | Oral |
| Comparator | CEFACLOR ANHYDROUS | Small molecule | — | Oral |
| Comparator | CEFPROZIL ANHYDROUS, (E)- | Small molecule | — | Oral |
| Comparator | Capreomycin | Protein / enzyme biologic | — | Oral |
| Comparator | Carbenicillin Indanyl | Small molecule | — | Oral |
| Comparator | Cefepime | Small molecule | — | Oral |
| Comparator | Cefixime | Other / unclassified | — | Oral |
| Comparator | Cefonicid | Small molecule | — | Oral |
| Comparator | Cefoperazone | Small molecule | — | Oral |
| Comparator | Cefotaxime | Small molecule | — | Oral |
| Comparator | Cefotetan | Small molecule | — | Oral |
| Comparator | Cefoxitin | Small molecule | — | Oral |
| Comparator | Cefpodoxime proxetil | Small molecule | — | Oral |
| Comparator | Ceftazidime | Small molecule | — | Oral |
| Comparator | Ceftibuten | Small molecule | — | Oral |
| Comparator | Ceftizoxime | Small molecule | — | Oral |
| Comparator | Ceftriaxone | Other / unclassified | — | Oral |
| Comparator | Cefuroxime | Small molecule | — | Oral |
| Comparator | Chlortetracycline | Small molecule | — | Oral |
| Comparator | Cinoxacin | Small molecule | — | Oral |
| Comparator | Ciprofloxacin | Small molecule | — | Oral |
| Comparator | Clarithromycin | Small molecule | — | Oral |
| Comparator | Clindamycin | Unknown | — | Oral |
| Comparator | Colistin | Other / unclassified | — | Oral |
| Comparator | Cycloserine | Small molecule | — | Oral |
| Comparator | Demeclocycline | Small molecule | — | Oral |
| Comparator | Dicloxacillin | Small molecule | — | Oral |
| Comparator | Dirithromycin | Small molecule | — | Oral |
| Comparator | Doxycycline | Small molecule | — | Oral |
| Comparator | Enoxacin | Small molecule | — | Oral |
| Comparator | Erythromycin | Small molecule | — | Oral |
| Comparator | Erythromycin ethylsuccinate + sulfisoxazole | Unknown | — | Oral |
| Comparator | Ethionamide | Small molecule | — | Oral |
| Comparator | Fosfomycin | Small molecule | — | Oral |
| Comparator | Gatifloxacin | Small molecule | — | Oral |
| Comparator | Gentamicin | Small molecule | — | Oral |
| Comparator | Grepafloxacin | Small molecule | — | Oral |
| Comparator | Imipenem-Cilastatin | Unknown | — | Oral |
| Comparator | Isoniazid | Small molecule | — | Oral |
| Comparator | Kanamycin | Small molecule | — | Oral |
| Comparator | LORACARBEF ANHYDROUS | Small molecule | — | Oral |
| Comparator | Levofloxacin | Small molecule | — | Oral |
| Comparator | Lincomycin | Small molecule | — | Oral |
| Comparator | Linezolid | Other / unclassified | — | Oral |
| Comparator | Lomefloxacin | Small molecule | — | Oral |
| Comparator | Mafenide | Small molecule | — | Oral |
| Comparator | Meropenem | Small molecule | — | Oral |
| Comparator | Methacycline | Small molecule | — | Oral |
| Comparator | Methenamine | Unknown | — | Oral |
| Comparator | Methicillin | Small molecule | — | Oral |
| Comparator | Metronidazole | Small molecule | — | Oral |
| Comparator | Mezlocillin | Small molecule | — | Oral |
| Comparator | Minocycline | Small molecule | — | Oral |
| Comparator | Moxifloxacin | Small molecule | — | Oral |
| Comparator | Mupirocin | Small molecule | — | Oral |
| Comparator | Nalidixic acid | Small molecule | — | Oral |
| Comparator | Neomycin | Unknown | — | Oral |
| Comparator | Netilmicin | Small molecule | — | Oral |
| Comparator | Nitrofurantoin | Unknown | — | Oral |
| Comparator | Nitrofurazone | Small molecule | — | Oral |
| Comparator | Norfloxacin | Small molecule | — | Oral |
| Comparator | Novobiocin | Small molecule | — | Oral |
| Comparator | Ofloxacin | Small molecule | — | Oral |
| Comparator | Oxytetracycline | Small molecule | — | Oral |
| Comparator | Paromomycin | Small molecule | — | Oral |
| Comparator | Penicillin G (Benzathine, Potassium, Procaine) | Unknown | — | Oral |
| Comparator | Penicillin V | Small molecule | — | Oral |
| Comparator | Piperacillin | Small molecule | — | Oral |
| Comparator | Piperacillin+Tazobactam | Unknown | — | Oral |
| Comparator | Polymyxin B | Peptide | — | Oral |
| Comparator | Pyrazinamide | Small molecule | — | Oral |
| Comparator | Quinopristin+Dalfopristin | Unknown | — | Oral |
| Comparator | Rifabutin | Small molecule | — | Oral |
| Comparator | Rifampin | Small molecule | — | Oral |
| Comparator | Rifapentine | Small molecule | — | Oral |
| Comparator | Silver Sulfadiazine | Small molecule | — | Oral |
| Comparator | Sparfloxacin | Small molecule | — | Oral |
| Comparator | Spectinomycin | Small molecule | — | Oral |
| Comparator | Sulfacetamide | Small molecule | — | Oral |
| Comparator | Sulfadiazine | Unknown | — | Oral |
| Comparator | Sulfamethizole | Small molecule | — | Oral |
| Comparator | Sulfamethoxazole | Small molecule | — | Oral |
| Comparator | Sulfasalazine | Small molecule | — | Oral |
| Comparator | Sulfisoxazole | Small molecule | — | Oral |
| Comparator | T roleandomycin | Small molecule | — | Oral |
| Comparator | T rovafloxacin | Small molecule | — | Oral |
| Comparator | Teicoplanin | Other / unclassified | — | Oral |
| Comparator | Tetracycline | Unknown | — | Oral |
| Comparator | Ticarcillin | Small molecule | — | Oral |
| Comparator | Ticarcillin+Clavulanic Acid | Unknown | — | Oral |
| Comparator | Tobramycin | Small molecule | — | Oral |
| Comparator | Trimethoprim | Small molecule | — | Oral |
| Comparator | Vancomycin | Other / unclassified | — | Oral |
| Comparator | cefdinir | Other / unclassified | — | Oral |
| Comparator | cefuroxime axetil | Small molecule | — | Oral |
| Comparator | chloramphenicol | Small molecule | — | Oral |
| Comparator | cloxacillin | Other / unclassified | — | Oral |
| Comparator | nafcillin | Small molecule | — | Oral |
| Comparator | oxacillin | Small molecule | — | Oral |
| Comparator | streptomycin | Other / unclassified | — | Oral |
| Comparator | trimethoprim-sulfamethoxazole | Unknown | — | Oral |