A Blind (treatment to be received is not known), Controlled (a chance to receive any of the treatments to be given) Study to Assess How Safe and Acceptable Ceftaroline and Ceftriaxone are and Whether both can be Used to Treat Young Children Who have Pneumonia and Need to be Hospitalized.

Conditions: Community-acquired Bacterial Pneumonia
MedDRA version: 14.1Level: PTClassification code 10035664Term: PneumoniaSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: LLTClassification code 10004051Term: Bacterial pneumonia, unspecifiedSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: PTClassification code 10060946Term: Pneumonia bacterialSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2012-002203-18-Outside-EU/EEA

Lead Sponsor: Cerexa, Inc. (subsidary of Forest Laboratories)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 160

Inclusion Criteria

1. Informed consent in writing from parent(s) or other 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 of age.
3. Presence of CABP requiring hospitalization and IV antibacterial therapy
4. Presence of CABP meeting each of the following criteria:
I. Fever (temperature > 38.0°C) or hypothermia (temperature <35.0°C). Note that temperature should not be measured by the axillary method.
II. New infiltrate(s) compatible with bacterial pneumonia, including a new alveolar/lobar infiltrate or consolidation (based on imaging results or diagnostic testing)
III. Acute onset or worsening within the previous 5 days before randomization of at least 2 of the following clinical signs or symptoms:
- Cough
- Tachypnea, defined as (World Health Organization, 2011):
- 2 months to < 12 months: = 50 breaths/min
- 12 months to < 5 years: = 40 breaths/min
- = 5 years: = 20 breaths/min
- Dyspnea
- Grunting
- Sputum production
- Chest pain
- Cyanosis
- Evidence of pneumonia with parenchymal consolidation (eg, dullness on percussion, diminished breath sounds, egophony, bronchial breath sounds, rales or crackles)
- Increased work of breathing (eg, nasal flaring, chest wall retractions)
IV. Presence of at least 1 of the following:
- Organism consistent with a typical respiratory pathogen identified or isolated from a respiratory or blood culture
- Leukocytosis (> 15,000 white blood cells [WBC]/mm3)
- >15% immature neutrophils (bands) regardless of total peripheral WBC
- Leukopenia (< 4500 WBC/mm3) likely due to the bacterial infection
- Hypoxemia (oxygen saturation < 92% on room air)
5. Female subjects who have reached menarche must have a negative urine pregnancy test.
6. 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).
7. Sufficient IV access to receive medication.

Are the trial subjects under 18? yes
Number of subjects for this age range: 160
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 any ß-lactam antimicrobial.
2. Confirmed or suspected infection with a pathogen known to be resistant to ceftriaxone (eg, Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus [MRSA]) or known infection at baseline with a sole atypical organism (eg, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Chlamydia trachomatis, Legionella pneumophila). Epidemiological clues to potential MRSA infection include necrotizing pneumonia, existence of an ongoing local MRSA infection outbreak, known skin colonization with MRSA, recent invasive MRSA infection, and recent influenza. Subjects with risk factors for MRSA infection who have predominance of gram-positive cocci in clusters on sputum Gram stain should also be excluded.
3. Confirmed or suspected respiratory tract infection attributable to sources other than community-acquired bacterial pathogens (eg, ventilator-associated pneumonia; hospital-acquired pneumonia [occurring 48 hours or more after admission, which was not incubating at the time of admission (Niederman, 1996; Tablan et al, 2004)]; visible/gross aspiration pneumonia; suspected sole viral [eg, respiratory syncytial virus], fungal, Mycobacterium tuberculosis infection of the lung); chronic lung disease or neurologic disease preventing normal clearance of secretions.
4. Non-infectious causes of pulmonary infiltrates (eg, cystic fibrosis, chemical pneumonitis from aspiration, hypersensitivity pneumonia) on chest radiography.
5. More than 24 hours of any potentially effective systemic antibacterial therapy for CABP within 96 hours before randomization.
EXCEPTIONS:
a) Microbiological or clinical treatment failure with an antibiotic other than IV study drugs that was administered for at least 48 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. Requirement for more than 10 days of systemic corticosteroid therapy (any dose)
8. History of seizures, excluding febrile seizure of childhood.
9. Creatinine clearance < 50 mL/min/1.73 m2 as calculated using the updated Schwartz bedside” formula (Schwartz et al, 2009):
CrCl (mL/min/1.73 m2) = 0.413 × height (length) (cm)/serum creatinine (mg/dL).
10. Clinical signs or suspicion of bacterial meningitis.
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 human immunodeficiency virus (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)
12. Evidence of immediately life-threatening disease, progressively fatal disease, or life expectancy of 3 months or less.
13. Females who are currently pregnant or breastfeedi

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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