Patients Response to Early Switch To Oral:Osteomyelitis Study

NCT02099240 | Terminated Early Phase 1 DMC

• 1 other identifier: 14.0185
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteomyelitis

Keywords

Osteomyelitis; IV Antibiotics; Oral Antibiotics

Outcome Measures

Primary Outcomes (1)

• Clinical Failures

  Clinical failure will be defined as clinical or laboratory evidence of infection collected from the patient's medical record documents.

  1 month

Secondary Outcomes (2)

• Evaluation of adverse events related to the use of antibiotics

  1 month

• Cost of care from the hospital perspective

  12 months

Study Arms (2)

Intravenous antibiotics

ACTIVE COMPARATOR

Intravenous antibiotics for the full duration of therapy

Procedure: intravenous antibiotics

oral antibiotics

ACTIVE COMPARATOR

intravenous antibiotic therapy plus early switch to oral antibiotic therapy

Drug: oral antibiotics

Interventions

oral antibiotics DRUG

intravenous antibiotics with early switch to oral antibiotics, antibiotic type will be dependent on bacteria type

Also known as: Amoxicillin, Amoxil®, Ampicillin, Omnipen®, Bacampicillin, Spectrobid®, Carbenicillin Indanyl, Pyopen®, Geogen®, Geocillin®, Mezlocillin, Mezlin®, Piperacillin*, Pipracil®, Ticarcillin, Ticar®, Amoxicillin-Clavulanic Acid, Augmentin®, Ampicillin-Sulbactam*, Unasyn®, Benzylpenicillin, Benpen®, Cloxacillin, Tegopen®, Coxapen®, Dicloxacillin, Dycill®, Dynapen®, Pathocil®, Methicillin, Staphcillin®, Oxacillin, Prostaphilin®, Bactocil®, Penicillin G (Benzathine, Potassium, Procaine), Bicillin® C-R/L-A, Pfizerpen®, Wycellin®, Penicillin V, Pen-Veek®, Beepen-VK®, Piperacillin+Tazobactam*, Zozyn®, Ticarcillin+Clavulanic Acid, Timentin®, Nafcillin, Unipen®, Nafcil®, Cefaclor, Ceclor®, Ceclor CD®, Cefamandol, Mandol®, Cefonicid, Monocid®, Cefotetan, Cefotan®, Cefoxitin, Mefoxin®, Cefprozil, Cefzil®, Ceftmetazole, Zefazone®, Cefuroxime, Kefurox®, Zinacef®, Cefuroxime axetil, Ceftin®, Loracarbef, Lorabid®Cefdinir, Omnicef®, Ceftibuten, Cedax®, Cefoperazone, Cefobid®, Cefixime*, Suprax®, Cefotaxime*, Claforan®, Cefpodoxime proxetil, Vantin®, Ceftazidime*, Ceptaz®, Fortaz®, Tanicef®, Ceftizoxime*, Cefizox®, Ceftriaxone*, Rocephin®, Cefepime, Maxipime®, Azithromycin*, Zithromax®, Clarithromycin*, Biaxin®, Clindamycin, Cleocin®, Dirithromycin, Dynabac®, Erythromycin, E-mycin®, Ery-tab®, Benzamycin®, Lincomycin, Lincocin®, T roleandomycin, T ao®, Cinoxacin, Cinoxacin®, Ciprofloxacin*, Cipro®, Enoxacin, Penetrex®, Gatifloxacin, T equin®, Grepafloxacin, Levofloxacin, Levaquin®, Quixin®, Lomefloxacin, Maxaquin®, Moxifloxacin, A velox®, Nalidixic acid, NegGam®, Norfloxacin*, Noroxin®, Ofloxacin, Floxin®, Sparfloxacin, Zagam®, T rovafloxacin, T rovan®, Imipenem-Cilastatin*, Primaxin®, Meropenem, Merrem®, Aztreonam*, Azactam®, Amikacin*, Amikin®, Gentamicin, Garamycin®, Kanamycin, Kantrex®, Neomycin, Mycifradin®, Neo-Fradin®, Netilmicin, Netromycin®, Streptomycin, Streptomycin®, T obramycin*, Tobrex®, Nebcin®, Paromomycin, Humatin®, T eicoplanin, T argocid®, Vancomycin*, Vancocyn®, Lyphocin®, Demeclocycline, Declomycin®, Doxycycline, Doxy®, Vibra®, Vibramycin®, Methacycline, Rondomycin®, Minocycline, Minocin®, Oxytetracycline, Terramycin®, T etracycline, Sumycin®, Chlortetracycline, Mafenide, Sulfamylon®, Silver Sulfadiazine, SSD®, Silvadene®, Sulfacetamide, Sultrim®, Sulfadiazine, Sulfamethoxazole, Gantanol®, Sulfasalazine, Sulfasalazine®,Azulfidine®, Sulfisoxazole, T rimethoprim-Sulfamethoxazole, Bactrim®, Septra®, Cofatrim®, Primsol®, Sulfamethizole, Thiosulfil Forte®, Rifabutin, Mycobutin®, Rifampin, Rifadin®, Rifapentine, Priftin®, Linezolid*, Zyvox®, Quinopristin+Dalfopristin*, Synercid®, Bacitracin, Baci-IM, Chloramphenicol*, Chloromycetin®, Colistemetate, Coly-Mycin® M & S, Fosfomycin, Monurol®, Isoniazid, Rifamate®, Methenamine, Hiprex®, Mandelamine®, Metronidazol, Flagyl®, Mupirocin, Bactroban®, Nitrofurantoin, Macrobid®, Macrodantin®, Furantoin®, Nitrofurazone, Furacin®, Novobiocin, Albamycin®, Polymyxin B, Aerospin®, Spectinomycin, T robicin®, T rimethoprim, Proloprim®, Trimpex®, Colistin, Cycloserine, Capreomycin, Ethionamide, Pyrazinamide, Para-aminosalicyclic acid, Erythromycin ethylsuccinate + sulfisoxazole

oral antibiotics

intravenous antibiotics PROCEDURE

intravenous antibiotics for the full duration of therapy, antibiotic type will be dependent on bacteria type

Also known as: Amoxicillin, Amoxil®, Ampicillin, Omnipen®, Bacampicillin, Spectrobid®, Carbenicillin Indanyl, Pyopen®, Geogen®, Geocillin®, Mezlocillin, Mezlin®, Piperacillin*, Pipracil®, Ticarcillin, Ticar®, Amoxicillin-Clavulanic Acid, Augmentin®, Ampicillin-Sulbactam*, Unasyn®, Benzylpenicillin, Benpen®, Cloxacillin, Tegopen®, Coxapen®, Dicloxacillin, Dycill®, Dynapen®, Pathocil®, Methicillin, Staphcillin®, Oxacillin, Prostaphilin®, Bactocil®, Penicillin G (Benzathine, Potassium, Procaine), Bicillin® C-R/L-A, Pfizerpen®, Wycellin®, Penicillin V, Pen-Veek®, Beepen-VK®, Piperacillin+Tazobactam*, Zozyn®, Ticarcillin+Clavulanic Acid, Timentin®, Nafcillin, Unipen®, Nafcil®, Cefaclor, Ceclor®, Ceclor CD®, Cefamandol, Mandol®, Cefonicid, Monocid®, Cefotetan, Cefotan®, Cefoxitin, Mefoxin®, Cefprozil, Cefzil®, Ceftmetazole, Zefazone®, Cefuroxime, Kefurox®, Zinacef®, Cefuroxime axetil, Ceftin®, Loracarbef, Lorabid®Cefdinir, Omnicef®, Ceftibuten, Cedax®, Cefoperazone, Cefobid®, Cefixime*, Suprax®, Cefotaxime*, Claforan®, Cefpodoxime proxetil, Vantin®, Ceftazidime*, Ceptaz®, Fortaz®, Tanicef®, Ceftizoxime*, Cefizox®, Ceftriaxone*, Rocephin®, Cefepime, Maxipime®, Azithromycin*, Zithromax®, Clarithromycin*, Biaxin®, Clindamycin, Cleocin®, Dirithromycin, Dynabac®, Erythromycin, E-mycin®, Ery-tab®, Benzamycin®, Lincomycin, Lincocin®, T roleandomycin, T ao®, Cinoxacin, Cinoxacin®, Ciprofloxacin*, Cipro®, Enoxacin, Penetrex®, Gatifloxacin, T equin®, Grepafloxacin, Levofloxacin, Levaquin®, Quixin®, Lomefloxacin, Maxaquin®, Moxifloxacin, A velox®, Nalidixic acid, NegGam®, Norfloxacin*, Noroxin®, Ofloxacin, Floxin®, Sparfloxacin, Zagam®, T rovafloxacin, T rovan®, Imipenem-Cilastatin*, Primaxin®, Meropenem, Merrem®, Aztreonam*, Azactam®, Amikacin*, Amikin®, Gentamicin, Garamycin®, Kanamycin, Kantrex®, Neomycin, Mycifradin®, Neo-Fradin®, Netilmicin, Netromycin®, Streptomycin, Streptomycin®, T obramycin*, Tobrex®, Nebcin®, Paromomycin, Humatin®, T eicoplanin, T argocid®, Vancomycin*, Vancocyn®, Lyphocin®, Demeclocycline, Declomycin®, Doxycycline, Doxy®, Vibra®, Vibramycin®, Methacycline, Rondomycin®, Minocycline, Minocin®, Oxytetracycline, Terramycin®, T etracycline, Sumycin®, Chlortetracycline, Mafenide, Sulfamylon®, Silver Sulfadiazine, SSD®, Silvadene®, Sulfacetamide, Sultrim®, Sulfadiazine, Sulfamethoxazole, Gantanol®, Sulfasalazine, Sulfasalazine®,Azulfidine®, Sulfisoxazole, T rimethoprim-Sulfamethoxazole, Bactrim®, Septra®, Cofatrim®, Primsol®, Sulfamethizole, Thiosulfil Forte®, Rifabutin, Mycobutin®, Rifampin, Rifadin®, Rifapentine, Priftin®, Linezolid*, Zyvox®, Quinopristin+Dalfopristin*, Synercid®, Bacitracin, Baci-IM, Chloramphenicol*, Chloromycetin®, Colistemetate, Coly-Mycin® M & S, Fosfomycin, Monurol®, Isoniazid, Rifamate®, Methenamine, Hiprex®, Mandelamine®, Metronidazol, Flagyl®, Mupirocin, Bactroban®, Nitrofurantoin, Macrobid®, Macrodantin®, Furantoin®, Nitrofurazone, Furacin®, Novobiocin, Albamycin®, Polymyxin B, Aerospin®, Spectinomycin, T robicin®, T rimethoprim, Proloprim®, Trimpex®, Colistin, Cycloserine, Capreomycin, Ethionamide, Pyrazinamide, Para-aminosalicyclic acid, Erythromycin ethylsuccinate + sulfisoxazole

Intravenous antibiotics

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Julio Ramirez: lead
• University of Louisville: collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Publications (6)

• Lew DP, Waldvogel FA. Osteomyelitis. Lancet. 2004 Jul 24-30;364(9431):369-79. doi: 10.1016/S0140-6736(04)16727-5.

  PMID: 15276398 RESULT

• 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.

  PMID: 8948280 RESULT

• 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.

  PMID: 4902833 RESULT

• 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.

  PMID: 15840453 RESULT

• 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.

  PMID: 19588358 RESULT

• 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.

  PMID: 22530208 RESULT

MeSH Terms

Conditions

Osteomyelitis

Interventions

Anti-Bacterial Agents; Amoxicillin; Ampicillin; bacampicillin; carbenicillin indanyl; Carbenicillin; Mezlocillin; Piperacillin; Ticarcillin; Amoxicillin-Potassium Clavulanate Combination; sultamicillin; Penicillin G; Cloxacillin; Dicloxacillin; Methicillin; Oxacillin; benzathine; Potassium; Procaine; Penicillin V; Piperacillin, Tazobactam Drug Combination; ticarcillin-clavulanic acid; Nafcillin; Cefaclor; Cefamandole; cefamandole nafate; Cefonicid; Cefotetan; Cefoxitin; Cefprozil; Cefmetazole; Cefuroxime; cefuroxime axetil; loracarbef; Cefdinir; Ceftibuten; Cefoperazone; Cefixime; Cefotaxime; Cefpodoxime Proxetil; Ceftazidime; Ceftizoxime; Ceftriaxone; Cefepime; Azithromycin; Clarithromycin; Clindamycin; dirithromycin; Erythromycin; benzoyl peroxide, erythromycin drug combination; Lincomycin; Cinoxacin; Ciprofloxacin; Enoxacin; Gatifloxacin; grepafloxacin; Levofloxacin; lomefloxacin; Moxifloxacin; Nalidixic Acid; Norfloxacin; Ofloxacin; sparfloxacin; Cilastatin, Imipenem Drug Combination; Meropenem; Aztreonam; Amikacin; Gentamicins; Kanamycin; Neomycin; Netilmicin; Streptomycin; Tobramycin; Paromomycin; Vancomycin; Demeclocycline; Doxycycline; Methacycline; Minocycline; Oxytetracycline; Tetracycline; Chlortetracycline; Mafenide; Silver Sulfadiazine; Sulfacetamide; Sulfadiazine; Sulfamethoxazole; Sulfasalazine; Sulfisoxazole; Trimethoprim, Sulfamethoxazole Drug Combination; Thymidine Monophosphate; Sulfamethizole; Rifabutin; Rifampin; rifapentine; Linezolid; quinupristin-dalfopristin; Bacitracin; Chloramphenicol; Fosfomycin; Isoniazid; Methenamine; methenamine hippurate; methenamine mandelate; Benchmarking; Metronidazole; Mupirocin; Nitrofurantoin; Nitrofurazone; Novobiocin; Polymyxin B; Spectinomycin; Trimethoprim; Colistin; Cycloserine; Capreomycin; Ethionamide; Pyrazinamide; Erythromycin Ethylsuccinate

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clavulanic Acid; Clavulanic Acids; Drug Combinations; Pharmaceutical Preparations; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Tazobactam; Penicillanic Acid; Sulfones; Cephalexin; Cephalosporins; Thiazines; Cephamycins; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Cephacetrile; Cefpodoxime; Cephaloridine; Macrolides; Polyketides; Lactones; Lincosamides; Pyrrolidines; Glycosides; Carbohydrates; Acids, Heterocyclic; Heterocyclic Compounds, 3-Ring; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Naphthyridines; Imipenem; Thienamycins; Carbapenems; Cilastatin; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Monobactams; Aminoglycosides; Sisomicin; Nebramycin; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Benzenesulfonamides; Sulfonamides; Sulfanilamides; Aniline Compounds; Amines; Pyrimidines; Thymine Nucleotides; Pyrimidine Nucleotides; Deoxyribonucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Sulfathiazoles; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Acetamides; Acetates; Acids, Acyclic; Oxazolidinones; Oxazoles; Peptides, Cyclic; Propylene Glycols; Glycols; Alcohols; Nitrobenzenes; Nitro Compounds; Organophosphonates; Organophosphorus Compounds; Hydrazines; Isonicotinic Acids; Pyridines; Polyamines; Adamantane; Bridged-Ring Compounds; Management Audit; Organization and Administration; Health Services Administration; Program Evaluation; Quality of Health Care; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Nitroimidazoles; Imidazoles; Epoxy Compounds; Ethers, Cyclic; Ethers; Pyrans; Nitrofurans; Furans; Aminocoumarins; Coumarins; Benzopyrans; Polymyxins; Lipopeptides; Antimicrobial Cationic Peptides; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins; Dioxanes; Isoxazoles; Serine; Amino Acids, Neutral; Amino Acids; Pyrazines

Study Officials

• David Seligson, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

• Julio Ramirez, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 28, 2014
• Study Start: March 6, 2014
• Primary Completion: November 7, 2018
• Study Completion: November 7, 2018
• Last Updated: April 6, 2021

Record last verified: 2021-04

Locations

US (1)