check_circleStudy Completed

Infectious Diseases

A study to assess efficacy and safety of IV/PO moxifloxacin in the treatment of cSSSIs

Trial purpose

The purpose of this study is to assess if a therapy with intravenous and oral moxifloxacin is as effective as a therapy with intravenous and oral amoxicilline/clavulanate in the treatment of complicated skin and skin structure infection.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Written informed consent
    - Men or women of age >/= 18 years with a diagnosis of bacterial skin and skin structure infection that requires
     -- Hospitalization
     -- Initial parenteral therapy for at least 48 hours
    - Complicated by at least one of the following criteria:
     -- Involvement of deep soft tissues (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.
     -- Presence of SIRS (Systemic Inflammatory Response Syndrome) defined as two or more of the following signs or symptoms: - temperature > 38.3°C or < 36°C - white blood cell count > 12.000/mmc or < 4.000 or > 10% bands - pulse rate > 90 beats/min - respiratory rate > 20178 - systolic blood pressure 2 seconds - lactate > 2 mmol/L - altered mental status - hyperglycemia > 120 mg/dl or 7.7 mmol/L in the absence of diabetes - protein C (CPR) > 20 mg/L (VR 0-5)3. Duration of infection < 21 days
    - Diagnosis of one of the following skin and skin structure infections:
     -- major abscess(es) associates with extensive cellulitis
     -- erysipelas and cellulitis
     -- infected pressure ulcers(s)
     -- wound infections including: post surgical (surgical incision), post traumatic, human bite/clenched fist and animal bite wound and wound associated with injection drug abuse
     -- Infected ischemic ulcers with at least one of the following conditions: - Diabetes mellitus - Peripheral vascular disease - Conditions pre-disposing to pressure scores such as paraplegia or peripheral neuropathy
    - Presence of at least 3 of the following local signs and symptoms
     -- purulent drainage or discharge
     -- erythema extended >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 (blends) regardless of total peripheral WBC count
     -- C-reactive protein (CRP) >20 mg/L
  • - 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 Fournier's gangrene, ecthyma gangrenosum, streptococcal necrotizing fasciitis and clostridial necrotizing fasciitis.
     -- Burn wound infections.
     -- Secondary infections of a chronic skin disease (eg, atopic dermatitis).
     -- Infection of prosthetic materials. 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

Trial summary

Enrollment Goal
16
Trial Dates
November 2008 - October 2009
Phase
Phase 3
Could I Receive a placebo
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
ASL TO/2 - PiemonteTorino, 10149, Italy
Terminated
A.O. Osp Circolo e Fond.MacchiVarese, 21100, Italy
Terminated
A.O. Carlo PomaMantova, 46100, Italy
Terminated
A.O. Ospedali Riuniti BergamoBergamo, 24128, Italy
Terminated
A.O.U. Policlinico ConsorzialeBari, 70124, Italy
Completed
A.O.U. CareggiFirenze, 50139, Italy
Terminated
A.O.U. Ospedali Riuniti FoggiaFoggia, 71100, Italy
Terminated
A.O.U. di Bologna - Policlinico S.Orsola-MalpighiBologna, 40138, Italy
Completed
IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca CancroGenova, 16132, Italy
Terminated
A.O. Spedali CiviliBrescia, 25123, Italy
Terminated
A.O. di Reggio EmiliaReggio Emilia, 42100, Italy
Terminated
A.O.U. Santa Maria Misericordia UDUdine, 33100, Italy
Terminated
A.O.U. Integrata VeronaVerona, 37126, Italy
Terminated
A.O. di PadovaPadova, 35128, Italy
Terminated
A.O.U. di FerraraFerrara, 44100, Italy
Completed
A.O. Domenico CotugnoNapoli, 80131, Italy
Completed
IRCCS Ist SpallanzaniRoma, 00149, Italy
Terminated
AUSL 10 Firenze - ToscanaBagno di Ripoli, 50100, Italy
Terminated
Università Cattolica del Sacro CuoreRoma, 00168, Italy
Terminated
A.O. di PerugiaPerugia, 06122, Italy
Terminated
A.O. Papardo di MessinaMessina, 98158, Italy
Completed
AUSL Rimini - Emilia RomagnaRimini, 47900, Italy

Primary Outcome

  • Clinical response up to 14-21 days after the completion of study drug therapy (Test-of-Cure visit [TOC]).
    date_rangeTime Frame:
    Test-of-Cure visit [TOC].
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Clinical response assessed by the investigator on treatment Day 3-5
    date_rangeTime Frame:
    Day 3-5
    enhanced_encryption
    Safety Issue:
    no
  • Clinical response assessed by the investigator at the end-of-therapy (EOT).
    date_rangeTime Frame:
    At the end-of-therapy (EOT)
    enhanced_encryption
    Safety Issue:
    no
  • Time to switch from oral to IV therapy
    date_rangeTime Frame:
    Day of switch from oral to IV therapy
    enhanced_encryption
    Safety Issue:
    no
  • Bacteriological response (for microbiologically valid population) at the EOT and TOC
    date_rangeTime Frame:
    At the end-of-therapy (EOT), Test-of-Cure visit [TOC].
    enhanced_encryption
    Safety Issue:
    no

Trial design

A prospective, randomized, open label, active comparator, multicenter, national trial to compare the efficacy and safety of sequential IV/PO moxifloxacin 400 mg once daily versus IV amoxicillin/clavulanate 2,0/0,2 g every 8 hours followed by oral amoxicillin/clavulanate 875/125 mg every 8 hours in the treatment of adult subjects with complicated skin and skin structure infections
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2