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 |