Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects with Complicated Skin Infections

• Conditions: MedDRA version: 14.1Level: PTClassification code 10040872Term: Skin infectionSystem Organ Class: 10021881 - Infections and infestations; Acute Bacterial Skin and Skin Structure Infections; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-003812-22-LT
• Lead Sponsor: Cerexa, Inc. (subsidary of Forest Laboratories)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-25
• Last Update Posted: 19 August 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

1.Informed consent in writing from parent(s) or legally acceptable representative(s) and informed assent from subject (if age appropriate according to local requirements)
2. Male or female, 2 months to < 18 years old
3. Presence of ABSSSI warranting 3 days of initial hospitalization and a minimum of 3 days of IV antibacterial therapy, but no more than 14 days of total therapy (IV and PO combined)
4. Presence of ABSSSI with measurable margins of erythema (cellulitis), that includes deeper and/or extensive soft tissue involvement* (eg, deep and extensive cellulitis, erysipelas, or major abscess), or requires significant therapeutic surgical intervention** (eg, major abscess or an infected wound
[postoperative surgical or traumatic]), defined as:
• Abscess: presence of a loculated fluid collection with erythema (ie, cellulitis) extending from the abscess margin and onset within 7 days before randomization. A major abscess” either extends to deeper soft tissue or requires significant surgical intervention. Incision and drainage should be conducted within 24 hours after first dose of IV study drug. A minimum area of surrounding erythema (cellulitis) around the abscess is required for a subject to be enrolled in the study; refer to Appendix I for calculation and minimum size requirement.
• Wound infection: presence of either purulent/seropurulent discharge from the surgical/traumatic wound with erythema (ie, cellulitis) surrounding the wound margin. Onset must have occurred within 7 days before randomization and within 30 days following the trauma or surgical procedure. A minimum size of wound infection is required for a subject to be enrolled in the
study;
• Cellulitis/erysipelas: presence of advancing erythema, induration/edema, and heat with onset within 7 days before randomization. A minimum size of cellulitis/erysipelas is required for a subject to be enrolled in the study;
* Deeper soft tissue: subdermal tissue, including subcutaneous fat
** Significant surgical intervention: a major invasive therapeutic procedure (not including commonly performed minor procedures such as suture removal, superficial debridement of devitalized tissue, or routine wound care)
5. In addition to erythema (cellulitis), presence of at least 1 of the following local signs and symptoms of acute infection (present for < 10 days):
• Purulent or seropurulent drainage or discharge
• Induration/edema
• Fluctuance
• Heat or localized warmth
AND the presence of at least 1 of the following systemic signs:
• Fever (> 38°C [100.4°F]) or hypothermia (< 35°C [95.0°F]). Temperature should not be measured by the axillary method.
• WBC count > 12,000/mm3
• > 10% immature neutrophils (bands) regardless of total peripheral WBC
6. Female subjects who have reached menarche must have a negative urine pregnancy test
7. Female subjects who have reached menarche and are sexually active must be willing to practice sexual abstinence or dual methods of birth control (eg, condom or diaphragm with spermicidal foam or gel)
during treatment and for at least 28 days after the last dose of any study drug (IV or PO)
8. Sufficient IV access to receive medication
Are the trial subjects under 18? yes
Number of subjects for this age range: 270
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Documented history of any hypersensitivity or allergic reaction to vancomycin, aztreonam, or any ß-lactam antimicrobial
2. Uncomplicated skin and soft tissue infections such as simple abscess, impetiginous lesions, superficial or small size cellulitis, furunculosis, carbunculosis, or folliculitis.
3. Skin and skin structure infections with a high cure rate after surgical incision alone or after aggressive local skin care.
4. Skin and soft tissue infections with any of the following characteristics:
? Known or suspected anaerobic pathogens, Pseudomonas, Proteus, or ESBL-producing organisms
? Known or suspected fungal, parasitic, or viral pathogens as the cause for the ABSSSI
? Decubitus ulcer or diabetic foot infection
? Complicated by osteomyelitis, septic arthritis, or endocarditis
? Burn wound
? Underlying inflammatory skin disease that may obscure determination of response, such as atopic dermatitis
? Human or animal bite
? Rapidly necrotizing process such as necrotizing fasciitis
? Gangrene
? Presence of prosthetic materials
? Need for amputation
5. More than 24 hours of any systemic antibacterial therapy within 96 hours before randomization.
EXCEPTIONS:
a. Microbiological or clinical treatment failure with a nonstudy
antibacterial therapy that was administered for at least 72 hours.
Failure must be confirmed by either a microbiological laboratory
report or documented worsening clinical signs or symptoms.
b. Low-dose tetracycline derivative for acne (eg, doxycycline 50 mg
q12h)
6. Requirement for any potentially effective concomitant systemic antibacterial therapy.
7. History of seizures, excluding well-documented febrile seizure of childhood.
8. Creatinine clearance < 50 mL/min/1.73 m2 as calculated using the updated Schwartz bedside” formula (Schwartz et al, 2009):
0.413 × Height (length) (cm) CrCl (mL/min/1.73 m2) =
Serum creatinine (mg/dL)
9. Clinical signs or suspicion of meningitis
10. Current septic shock or acute hemodynamic instability including a requirement for pressor support.
11. Evidence of significant hepatic, hematologic, or immunocompromising condition (any of the following):
? Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal (× ULN) or total bilirubin level > 2 × ULN
? Known acute viral hepatitis
? Neutropenia (< 500 neutrophils/mm3)
? Thrombocytopenia (< 60,000 platelets/mm3)
? If HIV positive, has CD4 count < 250 cells/mm3 at the last measurement or history of AIDS-defining illness
? Bone marrow ablative therapy, including bone marrow transplantation, within the last 12 months
? Bone marrow or solid organ recipients who have had an episode of graft versus host disease or acute rejection episode, respectively, within the last 6 months
? Severe combined immunodeficiency disorder (SCID)
? Requirement for high-dose (eg, > 20 mg/day of prednisone or equivalent) or prolonged systemic corticosteroid therapy. Short courses of corticosteroids, such as those for currently worsening asthma, are permitted.
12. Evidence of immediately life-threatening disease, progressively fatal disease, or life expectancy of = 3 months
13. Females who are currently pregnant or breastfeeding
14. Participation in any study involving administration of an investigational agent or device within 30 days before the start of first dose of IV study drug or previously participated in the current study or in another study of ceftaroline fosamil (in whi

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified