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CompletedNCT00402727Updated Nov 7, 2014Results posted

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 interventional study of Moxifloxacin (Avelox, BAY12-8039) and Piperacillin/Tazobactam & Amoxicillin/Clavulanic acid in Abscess, Wound Infection and Diabetic Foot, sponsored by Bayer. Completed at 123 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-07.

Sponsored by Bayer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
813
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Abscess
  • Wound Infection
  • Diabetic Foot
  • Ulcer
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 813 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)
      • 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

Exclusion criteria

Exclusion Criteria:

  • 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
    • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
813 participants (actual)

Study arms

  • Experimental
    Moxifloxacin

    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.

    Drug: Moxifloxacin (Avelox, BAY12-8039)

  • Active comparator
    PIP/TAZ-AMC

    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.

    Drug: Piperacillin/Tazobactam & Amoxicillin/Clavulanic acid

Interventions

  • DrugMoxifloxacin (Avelox, BAY12-8039)

    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.

  • DrugPiperacillin/Tazobactam & Amoxicillin/Clavulanic acid

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 14 - 28 days after last dose of study medication

Secondary outcomes

  1. 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.

    Time frame: 14 - 28 days after last dose of study medication

  2. 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.

    Time frame: 3 - 5 days after start of treatment

  3. 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

    Time frame: 3 - 5 days after start of treatment

  4. 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.

    Time frame: after 7 - 21 days of treatment

  5. 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.

    Time frame: after 7 - 21 days of treatment

  6. 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.

    Time frame: 3 - 5 days after start of treatment

  7. 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.

    Time frame: 3 - 5 days after start of treatment

  8. 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.

    Time frame: after 7 - 21 days of treatment

  9. 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.

    Time frame: after 7 - 21 days of treatment

  10. 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.

    Time frame: 14 - 28 days after last dose of study medication

  11. 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.

    Time frame: 14 - 28 days after last dose of study medication

07

Results

Posted Jan 11, 2010
Limitations and caveats
Ten patients (six from the moxifloxacin group and 4 from the comparator group) did not receive study medication. They were excluded from the safety analyses. No adverse events were reported in these patients.

Participant flow

Participant flow — Overall Study
MilestoneMoxifloxacinPIP/TAZ-AMC
Started432381
Achieving end of treatment (eot)408355
Achieving test of cure (toc)390347
Completed390347
Not completed4234
Withdrew: Adverse event106
Withdrew: Death10
Withdrew: Lack of efficacy13
Withdrew: Lost to follow-up2411
Withdrew: Physician decision11
Withdrew: Protocol violation04
Withdrew: Withdrawal by subject37
Withdrew: Supply problems21
Withdrew: Non-compliance01

Outcome measures

PrimaryPercentage 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.

Time frame:
14 - 28 days after last dose of study medication
Reported as:
Number · percentage of participants
Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population
percentage of participantsMoxifloxacinPIP/TAZ-AMC
Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population88.689.6
Statistical analysis
  • Moxifloxacin vs PIP/TAZ-AMC · Difference of cure rates (in percent): -1.0 · 95% CI -5.3 to 3.9A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.
SecondaryPercentage 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.

Time frame:
14 - 28 days after last dose of study medication
Reported as:
Number · percentage of participants
Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Intent to Treat (ITT) Population
percentage of participantsMoxifloxacinPIP/TAZ-AMC
Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Intent to Treat (ITT) Population82.280.9
Statistical analysis
  • Moxifloxacin vs PIP/TAZ-AMC · Difference of cure rates (in percent): 1.3 · 95% CI -3.8 to 6.3A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
SecondaryPercentage 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.

Time frame:
3 - 5 days after start of treatment
Reported as:
Number · percentage of participants
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
percentage of participantsMoxifloxacinPIP/TAZ-AMC
Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Per Protocol (PP) Population98.399.0
Statistical analysis
  • Moxifloxacin vs PIP/TAZ-AMC · Difference of improvement rates (in %): -0.7 · 95% CI -1.6 to 0.6A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
SecondaryPercentage 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

Time frame:
3 - 5 days after start of treatment
Reported as:
Number · percentage of participants
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
percentage of participantsMoxifloxacinPIP/TAZ-AMC
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) Population97.295.8
Statistical analysis
  • Moxifloxacin vs PIP/TAZ-AMC · Difference of improvement rates (in %): 1.4 · 95% CI -1.3 to 3.9A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
SecondaryPercentage 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.

Time frame:
after 7 - 21 days of treatment
Reported as:
Number · percentage of participants
Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Per Protocol (PP) Population
percentage of participantsMoxifloxacinPIP/TAZ-AMC
Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Per Protocol (PP) Population95.395.1
Statistical analysis
  • Moxifloxacin vs PIP/TAZ-AMC · Difference of resolution rates (in %): 0.2 · 95% CI -3.1 to 2.4A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
SecondaryPercentage 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.

Time frame:
after 7 - 21 days of treatment
Reported as:
Number · percentage of participants
Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Intent to Treat (ITT) Population
percentage of participantsMoxifloxacinPIP/TAZ-AMC
Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Intent to Treat (ITT) Population92.390.7
Statistical analysis
  • Moxifloxacin vs PIP/TAZ-AMC · Difference of resolution rates (in %): 1.6 · 95% CI -2.4 to 5.3A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
SecondaryPercentage 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.

Time frame:
3 - 5 days after start of treatment
Reported as:
Number · percentage of participants
Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the ITT Population With Causative Organisms
percentage of participantsMoxifloxacinPIP/TAZ-AMC
Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the ITT Population With Causative Organisms54.663.1
Statistical analysis
  • Moxifloxacin vs PIP/TAZ-AMC · Difference of eradication rates (in %): -8.5 · 95% CI -17.0 to -1.4A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
SecondaryPercentage 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.

Time frame:
3 - 5 days after start of treatment
Reported as:
Number · percentage of participants
Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the Microbiological Valid (MBV) Population
percentage of participantsMoxifloxacinPIP/TAZ-AMC
Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the Microbiological Valid (MBV) Population55.263.8
Statistical analysis
  • Moxifloxacin vs PIP/TAZ-AMC · Difference of eradication rates (in %): -8.6 · 95% CI -17.6 to -0.4A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
SecondaryPercentage 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.

Time frame:
after 7 - 21 days of treatment
Reported as:
Number · percentage of participants
Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the ITT Population With Causative Organisms
percentage of participantsMoxifloxacinPIP/TAZ-AMC
Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the ITT Population With Causative Organisms84.087.9
Statistical analysis
  • Moxifloxacin vs PIP/TAZ-AMC · Difference of eradication rates (in %): -3.9 · 95% CI -9.5 to 1.4A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
SecondaryPercentage 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.

Time frame:
after 7 - 21 days of treatment
Reported as:
Number · percentage of participants
Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the Microbiological Valid (MBV) Population
percentage of participantsMoxifloxacinPIP/TAZ-AMC
Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the Microbiological Valid (MBV) Population85.891.4
Statistical analysis
  • Moxifloxacin vs PIP/TAZ-AMC · Difference of eradication rates (in %): -5.6 · 95% CI -11.4 to -0.8A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
SecondaryPercentage 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.

Time frame:
14 - 28 days after last dose of study medication
Reported as:
Number · percentage of participants
Percentage of Participants With Bacteriological Success (BS) After 14 - 28 Days After Last Dose of Study Medication in the ITT Population With Causative Organisms
percentage of participantsMoxifloxacinPIP/TAZ-AMC
Percentage of Participants With Bacteriological Success (BS) After 14 - 28 Days After Last Dose of Study Medication in the ITT Population With Causative Organisms78.979.0
Statistical analysis
  • Moxifloxacin vs PIP/TAZ-AMC · Difference of eradication rates (in %): -0.1 · 95% CI -6.9 to 5.4A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
SecondaryPercentage 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.

Time frame:
14 - 28 days after last dose of study medication
Reported as:
Number · percentage of participants
Percentage of Participants With Bacteriological Success (BS) After 14 - 28 Days After Last Dose of Study Medication in the Microbiological Valid (MBV) Population
percentage of participantsMoxifloxacinPIP/TAZ-AMC
Percentage of Participants With Bacteriological Success (BS) After 14 - 28 Days After Last Dose of Study Medication in the Microbiological Valid (MBV) Population84.387.2
Statistical analysis
  • Moxifloxacin vs PIP/TAZ-AMC · Difference of eradication rates (in %): -2.9 · 95% CI -9.3 to 2.2A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Moxifloxacin—21/426 (4.9%)35/426 (8.2%)
PIP/TAZ-AMC—14/377 (3.7%)20/377 (5.3%)
Most frequent serious events
Showing 10 of 35
Most frequent serious events
EventMoxifloxacinPIP/TAZ-AMC
GangreneInfections and infestations1/4263/377
Wound infectionInfections and infestations2/4261/377
Rectal abscessInfections and infestations2/4260/377
Electrocardiogram QT prolongedInvestigations2/4260/377
Cardiac failureCardiac disorders0/4261/377
Impaired healingGeneral disorders0/4261/377
Cirrhosis alcoholicHepatobiliary disorders0/4261/377
Localised infectionInfections and infestations1/4261/377
PneumoniaInfections and infestations0/4261/377
Muscle abscessInfections and infestations0/4261/377
Most frequent other events
Most frequent other events
EventMoxifloxacinPIP/TAZ-AMC
HypertensionVascular disorders11/4262/377
DiarrhoeaGastrointestinal disorders10/4268/377
PyrexiaGeneral disorders7/4263/377
Electrocardiogram QT prolongedInvestigations1/4265/377
NauseaGastrointestinal disorders5/4263/377
HeadacheNervous system disorders5/4263/377

Baseline characteristics

Age, Continuous
Age, Continuous(years)MoxifloxacinPIP/TAZ-AMCTotal
Mean53 ± 1654 ± 1653 ± 16
Sex: Female, Male
Sex: Female, Male(Participants)MoxifloxacinPIP/TAZ-AMCTotal
Female161123284
Male271258529
Primary diagnosis
Primary diagnosis(Participants)MoxifloxacinPIP/TAZ-AMCTotal
Major abscess184170354
Diabetic foot infection123110233
Wound infection7255127
Infected ischemic ulcer241842
No cSSSI292857
08

Study locations

123 sites
  • Graz, Steiermark 8036, Austria
  • Graz, 8036, Austria
  • Wien, 1090, Austria
  • Bornem, 2880, Belgium
  • Bruxelles - Brussel, 1070, Belgium
  • Bruxelles - Brussel, 1090, Belgium
  • Edegem, 2650, Belgium
  • Dobrich, 9300, Bulgaria
  • Pleven, 5800, Bulgaria
  • Ruse, 7002, Bulgaria
  • Sofia, 1309, Bulgaria
  • Sofia, 1431, Bulgaria
  • Sofia, 1606, Bulgaria
  • Annecy, 74000, France
  • Avignon, 84025, France
  • Boulogne Sur Mer, 62321, France
  • Denain, 59220, France
  • Grenoble, 38043, France
  • Le Grau Du Roi, 30240, France
  • Nevers, 58000, France
  • Quimper, 29000, France
  • Tourcoing, 59280, France
  • Mannheim, Baden-Württemberg 68135, Germany
  • München, Bayern 81377, Germany
  • Darmstadt, Hessen 64297, Germany
  • Wiesbaden, Hessen 65191, Germany
  • Hannover, Niedersachsen 30625, Germany
  • Bochum, Nordrhein-Westfalen 44791, Germany
  • Münster, Nordrhein-Westfalen 48149, Germany
  • Mainz, Rheinland-Pfalz 55101, Germany
  • Magdeburg, Sachsen-Anhalt 39120, Germany
  • Lübeck, Schleswig-Holstein 23538, Germany
  • Hamburg, 20246, Germany
  • Athens, Attica 106 76, Greece
  • Athens, Attica 11527, Greece
  • Athens, 115 27, Greece
  • Athens, 124 62, Greece
  • Rio Patras, 265 00, Greece
  • Thessaloniki, 546 36, Greece
  • Budapest, 1027, Hungary
  • Debrecen, 4032, Hungary
  • Györ, 9024, Hungary
  • Kaposvar, 7400, Hungary
  • Szekesfehervar, 8000, Hungary
  • Veszprem, 8200, Hungary
  • Wilton, Cork, Ireland
  • Dublin, 7, Ireland
  • Dublin, 9, Ireland
  • Dublin, DUBLIN 4, Ireland
  • Galway, Ireland
  • Sligo, Ireland
  • Haifa, 31096, Israel
  • Tel Hashomer, 52621, Israel
  • Chieti, 66013, Italy
  • Milano, 20122, Italy
  • Pavia, 27100, Italy
  • Roma, 00167, Italy
  • Siena, 53100, Italy
  • Daugavpils, LV-5417, Latvia
  • Liepaja, LV 3400, Latvia
  • Riga, 1002, Latvia
  • Riga, 1005, Latvia
  • Riga, LV-1038, Latvia
  • Valmiera, LV-4201, Latvia
  • Kaunas, LT-3007, Lithuania
  • Siauliai, LT-76231, Lithuania
  • Ukmerge, LT-20184, Lithuania
  • Vilnius, 10207, Lithuania
  • Alkmaar, 1800 AM, Netherlands
  • Eindhoven, 5600 PD, Netherlands
  • Kraków, 30-501, Poland
  • Lublin, 20-081, Poland
  • Lublin, 20-718, Poland
  • Lublin, 20-954, Poland
  • Poznan, 60-479, Poland
  • Pulawy, 24-100, Poland
  • Warszawa, 02-097, Poland
  • Bucharest, 022328, Romania
  • Bucharest, 040215, Romania
  • Bucharest, 050099, Romania
  • Cluj-Napoca, 400006, Romania
  • Iasi, 700106, Romania
  • Moscow, 123567, Russian Federation
  • Moscow, 125206, Russian Federation
  • Moscow, 127486, Russian Federation
  • Moscow, 129110, Russian Federation
  • Moscow, 129327, Russian Federation
  • Moscow, 197046, Russian Federation
  • Smolensk, 214019, Russian Federation
  • St. Petersburg, 198099, Russian Federation
  • St. Petersburg, Russian Federation
  • Yaroslavl, 150003, Russian Federation
  • Johannesburg, Gauteng 2157, South Africa
  • Pretoria, Gauteng 0084, South Africa
  • Cape Town, Western Cape 7505, South Africa
  • Cape Town, Western Cape 7531, South Africa
  • Cape Town, Western Cape 7925, South Africa
  • Worcester, Western Cape 6850, South Africa
  • Oviedo, Asturias 33006, Spain
  • Terrassa (Barcelona), Catalunya 08221, Spain

Showing the first 100 of 123 sites across 20 countries.

09

References and documents

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 21896561 ↗
  • Schaper 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 23180507 ↗
  • D'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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00402727
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Nov 22, 2006
Start date
Sep 2006
Primary completion
Jun 2008
Completion
Jun 2008
Results posted
Jan 11, 2010
Last update
Nov 7, 2014

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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