Patients Response to Early Switch To Oral:Osteomyelitis Study (PRESTO:Osteo)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by University of Louisville
Sponsor:
Collaborators:
James Graham Brown Cancer Center
University of Louisville
Information provided by (Responsible Party):
Julio Ramirez, University of Louisville
ClinicalTrials.gov Identifier:
NCT02099240
First received: March 18, 2014
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Osteomyelitis
Drug: oral antibiotics
Procedure: intravenous antibiotics
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study to Compare Clinical Outcomes in Patients With Osteomyelitis Treated With Intravenous Antibiotics Versus Intravenous Antibiotics With an Early Switch to Oral Antibiotics

Resource links provided by NLM:

Drug Information available for: Procaine hydrochloride Penicillin G procaine Isoniazid Nitrofurantoin sodium Chloramphenicol Chlortetracycline Streptomycin Kanamycin Nitrofurazone Penicillin G Chlortetracycline hydrochloride Demeclocycline hydrochloride Oxacillin Nitrofurantoin Sulfadiazine Cycloserine Ampicillin sodium Ampicillin Penicillin G sodium Oxytetracycline Sulfisoxazole acetyl Pyrazinamide Methenamine Penicillin G potassium Erythromycin Penicillin V potassium Mafenide Sulfacetamide Sulfamethizole Nafcillin Lincomycin Potassium bicarbonate Dicloxacillin sodium Nalidixic acid Ethionamide Doxycycline Methenamine mandelate Sulfasalazine Erythromycin stearate Sulfamethoxazole Trimethoprim Chloramphenicol sodium succinate Nafcillin sodium Colistin Oxacillin sodium Paromomycin sulfate Erythromycin ethylsuccinate Colistin sulfate Gentamicin Neomycin Polymyxin B Vancomycin Vancomycin hydrochloride Neomycin sulfate Polymyxin B sulfate Capreomycin sulfate Gentamicin sulfate Bacitracin Bacitracin zinc Spectinomycin Oxytetracycline hydrochloride Chloramphenicol succinate Streptomycin sulfate Erythromycin phosphate Ticarcillin disodium Methenamine hippurate Sulfacetamide sodium Ampicillin trihydrate Lincomycin hydrochloride Potassium chloride Paromomycin Bicillin C-R Minocycline Capreomycin Mupirocin Mafenide acetate Rifampin Oxytetracycline Calcium Minocycline hydrochloride Doxycycline monohydrate Nitrofurantoin monohydrate Clindamycin Clindamycin hydrochloride Spectinomycin hydrochloride Sulfadiazine, silver Fosfomycin Doxycycline hyclate Clindamycin phosphate Kanamycin sulfate Clindamycin palmitate hydrochloride Carbenicillin indanyl sodium Amoxicillin Ticarcillin sodium Cefoxitin sodium Amoxicillin sodium Cefoxitin Clindamycin palmitate Amikacin sulfate Penicillin G benzathine Cefaclor Cefuroxime Cefuroxime sodium Piperacillin sodium Trimethoprim hydrochloride Rifapentine Piperacillin Cefoperazone Cefoperazone sodium Cefotaxime Imipenem Cefotaxime sodium Cefuroxime axetil Sulbactam Ceftizoxime Ceftizoxime sodium Sulbactam sodium Cefotetan Norfloxacin Rifabutin Ceftriaxone Ceftazidime sodium Cefotetan disodium Ceftriaxone sodium Loracarbef Aztreonam Ceftazidime Fosfomycin tromethamine Clarithromycin Cilastatin sodium Cilastatin Ofloxacin Azithromycin Ciprofloxacin Ciprofloxacin hydrochloride Cefpodoxime proxetil Cefepime Tazobactam Cefprozil Doxycycline calcium Meropenem Ceftibuten Lomefloxacin hydrochloride Levofloxacin Dalfopristin Gatifloxacin Mupirocin calcium Ceftibuten dihydrate Ofloxacin hydrochloride Cefepime hydrochloride Cefixime trihydrate Moxifloxacin Linezolid Moxifloxacin hydrochloride
U.S. FDA Resources

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Clinical Failures [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Clinical failure will be defined as clinical or laboratory evidence of infection collected from the patient's medical record documents.


Secondary Outcome Measures:
  • Evaluation of adverse events related to the use of antibiotics [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Antibiotic--‐related adverse events will be defined according to the Food and Drug Administration adverse events listed in the package insert of the antibiotic prescribed for each subject.

  • Cost of care from the hospital perspective [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Costs will be calculated from the hospital perspective and will include the costs of the antibiotic therapy, home healthcare (nursing--‐ and infusion--‐related), and length of hospital stay.


Estimated Enrollment: 456
Study Start Date: April 2014
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intravenous antibiotics
Intravenous antibiotics for the full duration of therapy
Procedure: intravenous antibiotics
intravenous antibiotics for the full duration of therapy, antibiotic type will be dependent on bacteria type
Other Names:
  • 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
Active Comparator: oral antibiotics
intravenous antibiotic therapy plus early switch to oral antibiotic therapy
Drug: oral antibiotics
intravenous antibiotics with early switch to oral antibiotics, antibiotic type will be dependent on bacteria type
Other Names:
  • 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02099240

Locations
United States, Kentucky
University of Louisville Not yet recruiting
Louisville, Kentucky, United States, 40202
Sub-Investigator: Forest Arnold, DO         
Sub-Investigator: Timothy Wiemkwn, PhD         
Sub-Investigator: Robert Kelley, PhD         
Sub-Investigator: James Summersgill, PhD         
Sub-Investigator: Ruth Carrico, PhD         
Sub-Investigator: Martin Gnoni, MD         
Sub-Investigator: Julie Harting, PharmD         
Sub-Investigator: Paula Peyrani, MD         
Principal Investigator: David Seligson, MD         
Sub-Investigator: Craig Roberts, MD         
Principal Investigator: Julio Ramirez, MD         
Sponsors and Collaborators
Julio Ramirez
James Graham Brown Cancer Center
University of Louisville
Investigators
Principal Investigator: David Seligson, MD University of Louisville
Principal Investigator: Julio Ramirez, MD University of Louisville
  More Information

Publications:
Responsible Party: Julio Ramirez, Professor of Medicine, University of Louisville
ClinicalTrials.gov Identifier: NCT02099240     History of Changes
Other Study ID Numbers: 14.0185
Study First Received: March 18, 2014
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by University of Louisville:
Osteomyelitis
IV Antibiotics
Oral Antibiotics

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Osteomyelitis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Moxifloxacin
Amoxicillin
Vancomycin
Doxycycline
Clarithromycin
Minocycline
Ciprofloxacin
Levofloxacin
Ofloxacin
Rifampin
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Ceftriaxone
Meropenem
Cycloserine
Isoniazid
Gentamicins
Methicillin
Colistin
Piperacillin
Erythromycin
Erythromycin Estolate

ClinicalTrials.gov processed this record on September 18, 2014