AbscessPhase 3NCT00402727
Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection
A Phase 3 study testing Moxifloxacin (Avelox, BAY12-8039) and Piperacillin/Tazobactam & Amoxicillin/Clavulanic acid in people with Abscess and Wound Infection, run by Bayer at 123 sites in 20 countries.
Trial summary
Patients, who are considered suitable by their physicians to take part in this research, will have a physical examination (including an Electrocardiogram (ECG)), blood and urine samples taken, as well as a sample of the secretions or tissue around their infection site. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abscess, Wound Infection, Diabetic Foot
- What is being tested?
- Moxifloxacin (Avelox, BAY12-8039) and Piperacillin/Tazobactam & Amoxicillin/Clavulanic acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 813 participants
- Where
- 123 sitesin 20 countries
- Study dates
- Sep 2006to Jun 2008
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Men or women of 18 years and above with a diagnosis of bacterial skin and skin structure infection that requires
- Hospitalization and
- Initial parenteral therapy for at least 48 hours and
- Meets at least one of the following criteria:
- Involvement of deep soft tissue (e.g. fascial, muscle layers)
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- Requirement for a significant surgical intervention including surgical drainage, drainage procedure guided by imaging and/or debridement
- Association with a significant underlying disease that may complicate response to treatment. An underlying disease is considered significant if it includes any of the following conditions that are present at the time of presentation: cancer (except basal- or squamous-cell cancer of the skin), cardiac (i.e., congestive heart disease), diabetes mellitus, hepatic (i.e., cirrhosis or another form of chronic liver disease), immunologic, renal disease, respiratory, transplantation or vascular disease
- Duration of infection < 21 days
- Diagnosis of one of the following skin and skin structure infections that requires hospitalization and initial parenteral antibiotic therapy for at least 48 hours:
- Major abscess(es) associated with extensive cellulitis, which requires antibiotic therapy in addition to surgical incision and drainage
- Diabetic foot infection of mild to severe intensity (perfusion, extent/size, depth/tissue loss, infection and sensation (PEDIS) grade 2-4) in the presence or absence of osteomyelitis. Subjects with osteomyelitis may only be enrolled if the infected bone is completely removed by surgery and if residual infection requiring antibiotics is still present following surgery
- Wound infection including: post surgical (surgical incision), post-traumatic, human bite/clenched fist and animal bite wound and wound associated with injection drug abuse:
- Infections must have occurred within 30 days of a surgical procedure, trauma, animal bite, or human bite, and involve the skin and skin structures at the site of the incision, trauma, or bite
- In addition, post-surgical/trauma wound infections must meet the following criteria:
- Involvement of deep soft tissues (e.g. fascial and muscle layers) of the incision/trauma
- At least one of the following criteria:
- Purulent drainage from the deep incision/trauma
- Identification of an infecting organism from an aseptically obtained culture of fluid or tissue from incision/trauma
- At least one of the following signs and symptoms:
- Localized pain or tenderness
- Fever (see below) AND the incision (in case of post-surgical wound infections) is deliberately opened by a surgeon, unless the culture is negative
- Abscess or other evidence of infection involving the deep incision/trauma, found on direct examination, during reoperation/operation (in case of trauma), or by histologic or radiologic examination
- Diagnosis of a deep incisional/post-trauma Skin Structure Infections (SSI) by a surgeon or attending physician
- Bite wounds/clenched fist infections and wounds associated with injection drug abuse must meet the criteria defining a Complicated Skin and Skin Structure Infections (cSSSI)
- Infected ischemic ulcers with at least one of the following conditions:
- Peripheral vascular disease
- Conditions pre-disposing to pressure sores such as paraplegia, peripheral neuropathy
- Presence of at least 3 of the following signs or symptoms:
- Purulent drainage or discharge
- Erythema extending > 1 cm from the wound edge
- Fluctuance
- Pain or tenderness to palpation
- Swelling or induration
- Fever, defined as body temperature
- > 37.5°C (axillary)
- > 38°C (orally)
- > 38.5°C (tympanically) or
- > 39°C (rectally)
- OR
- Elevated total peripheral white blood cell (WBC) count > 12,000/mm3 or
- >15 % immature neutrophils (bands) regardless of total peripheral WBC count
- C reactive protein (CRP) >20 mg/L
- Specimen obtained for culture from infected area by needle aspiration of obviously purulent material or by tissue biopsy or by curettage of the surface of ulcer within 48 hours prior to the initiation of study drug therapy
- Duration of treatment of the skin/skin structure infection is anticipated to be at least 7 days.
- Surgical drainage or debridement of infected wounds or abscesses, if necessary, have to have been completed <= 48 hours after the initiation of study drug therapy
Who cannot join
- Women, who are pregnant or lactating, or in whom pregnancy can not be excluded (Note: a urine pregnancy test has to be performed for all women of childbearing potential before randomization to the study drug)
- The following skin and skin structure infections:
- Necrotizing fasciitis including Fourniers gangrene, ecthyma gangrenosum, streptococcal necrotizing fasciitis and clostridial necrotizing fasciitis
- Burn wound infections
- Secondary infections of a chronic skin disease (e.g. atopic dermatitis)
- Infection of prosthetic materials (e.g. subcutaneous tissue infection related to a central venous catheter or permanent cardiac pacemaker battery pack). Subjects with removal of a prosthetic device involved in an infection should not be included
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- Infections where a surgical procedure alone is definitive therapy
- Subjects with uncomplicated skin and skin structure infections including folliculitis and furunculosis, carbunculosis, simple abscesses and superficial cellulitis
- Known hypersensitivity to quinolones and/or any type of beta-lactam antibiotic drugs or any of the excipients
- Previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin-clavulanic acid
- Severe, life threatening disease with a life expectancy of less than 2 months
- Immunosuppression including:
- Known neutropenia (neutrophil count < 1000/µL)
- Known lymphopenia with absolute CD4+ T cell count < 200/mm3
- Acquired immunodeficiency syndrome (AIDS)-defining event and/or concomitant therapy with Highly Active Antiretroviral Therapy (HAART)
- Chronic treatment (>/= 2 weeks) with known immunosuppressant therapy (including treatment with > 15 mg/day of systemic prednisone or equivalent)
- Any other congenital or acquired immune defect or immunosuppression
- Known severe hepatic insufficiency (Child Pugh C) or transaminases increase > 5 fold upper limit of normal (ULN)
- Known renal impairment with a baseline measured or calculated serum creatinine clearance < 40 mL/min
- Known prolongation of the QT interval or concomitant use of drugs reported to increase the QT interval (e.g. Class IA or Class III antiarrhythmics [eg., quinidine, procainamide, amiodarone, sotalol], neuroleptics [e.g. haloperidol], tricyclic antidepressive agents, certain antimicrobials [e.g. pentamidine, halofantrine], certain antihistaminics [e.g. terfenadine], and other [cisapride, vincamine IV, depridil, diphemanil])
- Uncorrected hypokalemia
- Clinically relevant bradycardia
- Clinically relevant heart failure with reduced left ventricular ejection fraction (i.e., below 40%)
- Previous history of symptomatic arrhythmias
- Previous history of tendon disease/disorder with quinolones
- Known or suspected concomitant bacterial infection requiring additional systemic antibacterial treatment, e.g. underlying septic arthritis
- Requiring therapy with probenecid
- Treatment with a systemic or topical antibacterial agent for > 24 hours in the previous 7 days preceding study entry unless the subject showed no response or had worsening of clinical signs and symptoms despite 3 or more days of prior therapy and a culture obtained at the time of subject enrollment showed persistence of a pathogen which is susceptible to the study drugs. The prior antimicrobial therapy must not have been a fluoroquinolone or a beta lactam/beta lactamase combination
- Infection known to be due to a Methicillin-Resistant Staphylococcus Aureus (MRSA), Methicillin-Resistant Staphylococcus Epidermidis (MRSE) or Vancomycin Resistant Enterococcus (VRE) as the single isolated pathogen
- Previous enrolment in this study
- Participation in any clinical investigational drug study within 4 weeks of screening
- Previous history of seizure disorders
Trial locations and contacts
123 sites in 20 countries.
123 sites in 20 countries
Germany11 sites
Study site
Bochum, North Rhine-Westphalia, 44791
Study site
Darmstadt, Hesse, 64297
Study site
Hamburg, Free and Hanseatic City of Hamburg, 20246
Study site
Hanover, Lower Saxony, 30625
Study site
Lübeck, Schleswig-Holstein, 23538
Study site
Magdeburg, Saxony-Anhalt, 39120
Study site
Mainz, Rhineland-Palatinate, 55101
Study site
Mannheim, Baden-Wurttemberg, 68135
Study site
München, Bavaria, 81377
Study site
Münster, North Rhine-Westphalia, 48149
Study site
Wiesbaden, Hesse, 65191
Russia10 sites
Study site
Moscow, 123567
Study site
Moscow, 125206
Study site
Moscow, 127486
Study site
Moscow, 129110
Study site
Moscow, 129327
Study site
Moscow, 197046
Study site
Saint Petersburg, 198099
Study site
Saint Petersburg
Study site
Smolensk, 214019
Study site
Yaroslavl, 150003
France9 sites
Study site
Annecy, 74000
Study site
Avignon, 84025
Study site
Boulogne-sur-Mer, 62321
Study site
Denain, 59220
Study site
Grenoble, 38043
Study site
Le Grau-du-Roi, 30240
Study site
Nevers, 58000
Study site
Quimper, 29000
Study site
Tourcoing, 59280
United Kingdom9 sites
Study site
Edinburgh, Lothian, EH16 4SA
Study site
Glasgow, Stratchclyde, G4 0SF
Study site
Inverness, Highland, IV2 3UJ
Study site
Leeds, West Yorkshire, LS1 3EX
Study site
London, Greater london, SE5 9RS
Study site
Manchester, Manchester, M13 9WL
Study site
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Study site
Winchester, Hampshire, SO22 5DG
Study site
York, York, YO13 8HE
Spain8 sites
Study site
Barcelona, Barcelona, 08025
Study site
Barcelona, Barcelona, 08036
Study site
Madrid, Madrid, 28007
Study site
Madrid, Madrid, 28034
Study site
Madrid, Madrid, 28047
Study site
Oviedo, Principality of Asturias, 33006
Study site
Salamanca, Salamanca, 37007
Study site
Terrassa (Barcelona), Catalonia, 08221
Ukraine8 sites
Study site
Ivano-Frankivsk, 76000
Study site
Kiev, 01021
Study site
Kiev, 01023
Study site
Kiev, 01103
Study site
Kiev, 01133
Study site
Lviv, 79659
Study site
Odesa, 65065
Study site
Uzhhorod, 88018
Poland7 sites
Study site
Krakow, 30-501
Study site
Lublin, 20-081
Study site
Lublin, 20-718
Study site
Lublin, 20-954
Study site
Poznan, 60-479
Study site
Puławy, 24-100
Study site
Warsaw, 02-097
Bulgaria6 sites
Study site
Dobrich, 9300
Study site
Pleven, 5800
Study site
Rousse, 7002
Study site
Sofia, 1309
Study site
Sofia, 1431
Study site
Sofia, 1606
Greece6 sites
Study site
Athens, Attica, 106 76
Study site
Athens, Attica, 11527
Study site
Athens, Greece, 124 62
Study site
Athens, 115 27
Study site
Rio Patras, 265 00
Study site
Thessaloniki, 546 36
Hungary6 sites
Study site
Budapest, 1027
Study site
Debrecen, 4032
Study site
Győr, 9024
Study site
Kaposvár, 7400
Study site
Székesfehérvár, 8000
Study site
Veszprém, 8200
Ireland6 sites
Study site
Dublin, Dublin, 7
Study site
Dublin, 9
Study site
Dublin, DUBLIN 4
Study site
Galway, Galway
Study site
Sligo
Study site
Wilton, Cork
Latvia6 sites
Study site
Daugavpils, LV-5417
Study site
Liepāja, LV 3400
Study site
Riga, 1002
Study site
Riga, 1005
Study site
Riga, LV-1038
Study site
Valmiera, LV-4201
South Africa6 sites
Study site
Cape Town, Western Cape, 7505
Study site
Cape Town, Western Cape, 7531
Study site
Cape Town, Western Cape, 7925
Study site
Johannesburg, Gauteng, 2157
Study site
Pretoria, Gauteng, 0084
Study site
Worcester, Western Cape, 6850
Italy5 sites
Study site
Chieti, 66013
Study site
Milan, 20122
Study site
Pavia, 27100
Study site
Roma, 00167
Study site
Siena, 53100
Romania5 sites
Study site
Bucharest, 022328
Study site
Bucharest, 040215
Study site
Bucharest, 050099
Study site
Cluj-Napoca, 400006
Study site
Iași, 700106
Belgium4 sites
Study site
Bornem, 2880
Study site
Bruxelles - Brussel, 1070
Study site
Bruxelles - Brussel, 1090
Study site
Edegem, 2650
Lithuania4 sites
Study site
Kaunas, LT-3007
Study site
Šiauliai, LT-76231
Study site
Ukmerge, LT-20184
Study site
Vilnius, 10207
Austria3 sites
Study site
Graz, Styria, 8036
Study site
Graz, 8036
Study site
Vienna, 1090
Netherlands2 sites
Study site
Alkmaar, 1800 AM
Study site
Eindhoven, 5600 PD
About this study
Official title: A Prospective, Randomized, Double Dummy, Double Blind, Multinational, Multicenter Trial Comparing the Safety and Efficacy of Sequential (Intravenous/Oral) Moxifloxacin 400 mg OD to Intravenous Piperacillin/Tazobactam 4.0/0.5 g Every 8 Hours Followed by Oral Amoxicillin/Clavulanic Acid Tablets 875/125 mg Every 12 Hours for the Treatment of Subjects With Complicated Skin and Skin Structure Infections
Patients, who are considered suitable by their physicians to take part in this research, will have a physical examination (including an Electrocardiogram (ECG)), blood and urine samples taken, as well as a sample of the secretions or tissue around their infection site. In addition, the site of the infection will be photographed. The patients will be randomly assigned one of the treatments: intravenous (IV)/per oral (PO) moxifloxacin (drug under evaluation) or IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid (i.e., one of the reference treatments for this kind of infection). The maximum treatment duration will be 21 days, and the minimum will be 7 days. During the hospitalization, the patients will have a physical examination every day. On Day 3-5 during therapy as well as at the end of treatment, the patients will have repeated examinations. These tests and evaluations will be repeated 14 to 28 days after the end of treatment. During this visit, blood and urine samples will be taken only if judged necessary by the physicians.
- Conditions
- Abscess, Wound Infection, Diabetic Foot, Ulcer
- Being tested
- Moxifloxacin (Avelox, BAY12-8039), Piperacillin/Tazobactam & Amoxicillin/Clavulanic acid
- Medical subject headings
- Abscess, Wound Infection, Diabetic Foot, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin (Avelox, BAY12-8039)Drug
Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
Piperacillin/Tazobactam & Amoxicillin/Clavulanic acidDrug
Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin | Experimental | Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory. Receives: Drug: Moxifloxacin (Avelox, BAY12-8039) |
| PIP/TAZ-AMC | Active comparator | Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory. Receives: Drug: Piperacillin/Tazobactam & Amoxicillin/Clavulanic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population
Clinical response was evaluated by the DRC and graded as "cure", "failure" or "indeterminate" at the TOC visit. Members of the DRC were provided with subject data from the study database that included clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.
Measured: 14 - 28 days after last dose of study medication
Secondary outcomes (11)
Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Intent to Treat (ITT) Population
Clinical response was evaluated by the DRC and graded as "cure", "failure" or "indeterminate" at the TOC visit. Members of the DRC were provided with subject data from the study database that included clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.
Measured: 14 - 28 days after last dose of study medication
Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Per Protocol (PP) Population
Clinical response was evaluated by the investigator and graded as "improvement in signs and symptoms," or "failure to respond," or "indeterminate" at Day 3 to 5 after treatment start based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.
Measured: 3 - 5 days after start of treatment
Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Intent to Treat (ITT) Population
Clinical response was evaluated by the investigator and graded as "improvement in signs and symptoms," or "failure to respond," or "indeterminate" at Day 3 to 5 after treatment start based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs
Measured: 3 - 5 days after start of treatment
Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Per Protocol (PP) Population
Clinical response was evaluated by the investigator and graded as "resolution," or "failure to respond," or "indeterminate" at the end of therapy based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.
Measured: after 7 - 21 days of treatment
Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Intent to Treat (ITT) Population
Clinical response was evaluated by the investigator and graded as "resolution", or "failure to respond," or "indeterminate" at the end of therapy based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.
Measured: after 7 - 21 days of treatment
Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the ITT Population With Causative Organisms
Bacteriological success was defined as presumed eradication or eradication without superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, superinfection as appearance of a new organism.
Measured: 3 - 5 days after start of treatment
Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the Microbiological Valid (MBV) Population
Bacteriological success was defined as presumed eradication or eradication without superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, superinfection as appearance of a new organism.
Measured: 3 - 5 days after start of treatment
Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the ITT Population With Causative Organisms
Bacteriological success is presumed eradication or eradication without recurrence or superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study, superinfection as appearance of a new organism.
Measured: after 7 - 21 days of treatment
Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the Microbiological Valid (MBV) Population
Bacteriological success is presumed eradication or eradication without recurrence or superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study, superinfection as appearance of a new organism.
Measured: after 7 - 21 days of treatment
Percentage of Participants With Bacteriological Success (BS) After 14 - 28 Days After Last Dose of Study Medication in the ITT Population With Causative Organisms
BS is presumed eradication or eradication without recurrence, super- or reinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study; super-, reinfection as appearance of a new organism during/after treatment.
Measured: 14 - 28 days after last dose of study medication
Percentage of Participants With Bacteriological Success (BS) After 14 - 28 Days After Last Dose of Study Medication in the Microbiological Valid (MBV) Population
BS is presumed eradication or eradication without recurrence, super- or reinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study; super-, reinfection as appearance of a new organism during/after treatment.
Measured: 14 - 28 days after last dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AbscessStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 813 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402727
- Sponsor's protocol ID
- 11974
- Other IDs
- 2006-001599-18
- Status last verified
- Nov 2014
- First submitted
- 21 Nov 2006
- Last updated
- 7 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gyssens IC, Dryden M, Kujath P, Nathwani D, Schaper N, Hampel B, Reimnitz P, Alder J, Arvis P. A randomized trial of the efficacy and safety of sequential intravenous/oral moxifloxacin monotherapy versus intravenous piperacillin/tazobactam followed by oral amoxicillin/clavulanate for complicated skin and skin structure infections. J Antimicrob Chemother. 2011 Nov;66(11):2632-42. doi: 10.1093/jac/dkr344. Epub 2011 Sep 6.
PubMed 21896561Schaper NC, Dryden M, Kujath P, Nathwani D, Arvis P, Reimnitz P, Alder J, Gyssens IC. Efficacy and safety of IV/PO moxifloxacin and IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid in the treatment of diabetic foot infections: results of the RELIEF study. Infection. 2013 Feb;41(1):175-86. doi: 10.1007/s15010-012-0367-x. Epub 2012 Nov 23.
PubMed 23180507D'Onofrio V, Monnier AA, Kremer C, Stappers MHT, Netea MG, Gyssens IC. Lesion size is associated with genetic polymorphisms in TLR1, TLR6, and TIRAP genes in patients with major abscesses and diabetic foot infections. Eur J Clin Microbiol Infect Dis. 2020 Feb;39(2):353-360. doi: 10.1007/s10096-019-03732-7. Epub 2019 Nov 30.
PubMed 31786695