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. 2013 Jun 4;2013(6):CD004874. doi: 10.1002/14651858.CD004874.pub4

Bradley 2007.

Methods This was a randomised (3:1, levofloxacin:comparator), open‐label, active‐comparator, non‐inferiority, multicentre study
Participants Children between 0.5 to 16 years old with a diagnosis of community‐acquired pneumonia (CAP). A diagnosis of CAP was defined as radiographic evidence of pulmonary infiltrate consistent with acute infection requiring antibiotic therapy, and the presence of 2 or more of the indications of pneumonia: fever (rectal or oral temperature 38 °C for children 2 years, or 38.3 °C for children 0.5 to 2 years), shortness of breath, cough, chest pain, abnormal white blood cell count (15,000/L or 5000/L), or physical signs of pneumonia on examination (e.g. rales on auscultation, dullness to percussion, egophony)
Interventions Levofloxacin or a comparator antibiotic for 10 days. Levofloxacin and comparators were given either orally or by intravenous (IV) administration. The patients were randomised in a 3:1 levofloxacin:comparator ratio within 14 strata in the study (1 for the 2 age groups within each country). For Group I (6 months to 5 years), levofloxacin was administered (a) 10 mg/kg/dose as oral suspension bd (up to 500 mg/d) or (b) 10 mg/kg/dose IV q12 hours (up to 500 mg/d). The comparator administration was (a) amoxycillin and clavulanic acid (7:1) oral suspension bd, with dose determined by calculating amoxycillin 22.5 mg/kg/dose (up to 875 mg/d), or (b) ceftriaxone 25 mg/kg/dose IV q12 hours (up to 4 G/d)
 For Group II (5 to 16 years), levofloxacin was administered (a) as 10 mg/kg/dose as oral suspension qd (up to 500 mg/d), (b) as 1 250 mg tablet qd (for children weighing 22.5 to 27.5 kg) or 2 250 mg tablets qd (for children weighing 45.5 kg), or (c) 10 mg/kg/dose IV q24 hours (up to 500 mg/d). The comparator administration was (a) clarithromycin 7.5 mg/kg/dose as oral suspension (or as a 250 mg tablet) bd (up to 250 mg bd), clarithromycin 250 mg oral tablet bd, or (b) ceftriaxone 25 mg/kg/dose IV q12 hours (up to 4 G/d), with either erythromycin lactobionate 10 mg/kg/dose IV q6 hours (up to 4 G/24 hours) or clarithromycin 7.5 mg/kg/dose as oral suspension (or as a 250 mg tablet) bd (up to 250 mg bd)
Outcomes Clinical response was categorised as cured, improved, clinical failure, relapse at test of cure visit (TOCV) 10 to 17 days after the last dose of study drug: (1) cured: resolution of signs and symptoms associated with active infection along with an improvement or lack of progression of abnormal findings of chest roentgenogram; (2) improved: continued incomplete resolution of signs and symptoms with no deterioration or relapse after post‐therapy visit (PTV) and no requirement for additional antimicrobial therapy; (3) clinical relapse: resolution or improvement of signs and symptoms at PTV evaluation with reappearance or deterioration of signs and symptoms of infection at test of cure visit (TOCV); (4) failure: patient was considered a clinical failure at PTV, response was carried forward to TOCV; and (5) unable to evaluate: unable to determine response because patient was not evaluated after PTV
Notes Exclusion criteria: received systemic antibiotics for more than 24 hours immediately before enrolment, required a systemic antibiotic other than the study drugs, or had a suspected infection with micro‐organisms known to be resistant to the study drugs. Other exclusion criteria included hospitalisation or residence in a long‐term care facility for 14 or more days before the onset of symptoms; infection acquired in a hospital (48 hours after hospital admission and 7 days after hospital discharge); signs and symptoms of a bacterial infection of the central nervous system; history or presence of arthropathy or periarticular disease or any other musculoskeletal signs or symptoms that in the opinion of the investigator may have confounded a future safety evaluation of musculoskeletal complaints
qd: once a day
bd: twice a day
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Sequence generation not mentioned
Allocation concealment (selection bias) Unclear risk Not mentioned clearly in the paper
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label randomised controlled trial
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Open‐label randomised controlled trial
Selective reporting (reporting bias) Unclear risk Information not clear
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Information not provided clearly
Other bias Unclear risk Funded by Johnson & Johnson Pharmaceutical Research and Development; details of role of funding agency not mentioned