Clinical trial NCT00828971: A Study to Assess Efficacy and Safety of IV/PO Moxifloxacin in the Treatment of cSSSIs
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infectious Diseases
Keywords: Complicated skin and skin structure infections
cSSSI
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-01-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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 \</= 90 mmgHg - decreased capillary refill/mottling \> 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

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 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

Primary outcomes:
measure: Clinical response up to 14-21 days after the completion of study drug therapy (Test-of-Cure visit [TOC]).
timeFrame: Test-of-Cure visit [TOC].
Secondary outcomes:
measure: Clinical response assessed by the investigator on treatment Day 3-5
timeFrame: Day 3-5
measure: Clinical response assessed by the investigator at the end-of-therapy (EOT).
timeFrame: At the end-of-therapy (EOT)
measure: Time to switch from oral to IV therapy
timeFrame: Day of switch from oral to IV therapy
measure: Bacteriological response (for microbiologically valid population) at the EOT and TOC
timeFrame: At the end-of-therapy (EOT), Test-of-Cure visit [TOC].
Other outcomes:
Locations:
city: Bagno di Ripoli
country: Italy
state: Firenze
city: Bari
country: Italy
city: Bergamo
country: Italy
city: Bologna
country: Italy
city: Brescia
country: Italy
city: Ferrara
country: Italy
city: Firenze
country: Italy
city: Foggia
country: Italy
city: Genova
country: Italy
city: Mantova
country: Italy
city: Messina
country: Italy
city: Napoli
country: Italy
city: Padova
country: Italy
city: Perugia
country: Italy
city: Reggio Emilia
country: Italy
city: Rimini
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Torino
country: Italy
city: Udine
country: Italy
city: Varese
country: Italy
city: Verona
country: Italy
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: