Grain et al.
|
2009–2013; 2014
|
Non-inferiority open-label, RCT
|
6 sites in 1 country (Switzerland)
|
Non-industry
|
602; 580 (289 vs. 291)
|
76 (median)
|
Moderately severe PNA
|
BL (IV cefuroxime 1.5 G X 3/d or IV amoxicillin/ clavulanate 1.2 G X 4/d) vs BL + ML (IV/PO clarithromycin 500 mg X 2/d)
|
10
|
Mortality = 30-day. Failure = no clinical stability at day 7
|
Petitpretz et al.
|
1997–1998; 2001
|
Superiority, double-blind, RCT
|
82 sites in 20 countries (Europe, South America, Australia, Africa)
|
Non-industry
|
411; 408 (200 vs. 208)
|
51 (mean)
|
Mild-moderate PNA; suspected pneumococcal PNA; 79% hospitalized/21% outpatients
|
BL (PO amoxicillin 1 G X 3/d) vs FQ (PO moxifloxacin 400 mg X 1/d)
|
10
|
Mortality = during the study (38-day). Failure = no clinical/bacteriological response 3–5 days after end of therapy
|
Norrby et al.
|
Not reported; 1998
|
Superiority, open-label, RCT
|
64 sites in 13 countries (Europe, North and South America, Africa, Asia)
|
Industry
|
625; 619 (314 vs. 305)
|
65 (median)
|
Moderately severe PNA; excluded strongly suspected mycoplasma, chlamydia or legionella PNA; 94% CAP and 6% nosocomial PNA
|
BL (IV ceftriaxone 4 G X 1/d) vs FQ (IV levofloxacin 500 mg X 2/d, followed by PO levofloxacin 500 mg X 2/d)
|
8
|
Mortality = during the study (29-day). Failure = no clinical/bacteriological response 2–5 days after end of therapy
|
Leophonte et al.
|
1998–1999; 2004
|
Superiority, double-blind, RCT
|
102 sites in 3 countries (Europe, Africa)
|
Non-industry
|
324; 320 (167 vs. 153)
|
54 (mean)
|
Mild-moderate PNA; suspected pneumococcal PNA; 94% hospitalized
|
BL (PO amoxicillin/ clavulanate 1.2 G X 3/d) vs FQ (PO gemifloxacin 320 mg X 1/d)
|
7 for FQ; 10 for B-lactam
|
Mortality = during the study (30-day). Failure = no clinical/ bacteriological response at end of therapy
|
Kalbermatter et al.
|
1998; 2000
|
Superiority, open-label, RCT
|
1 site in 1 country (Argentina)
|
Non-industry
|
84; 84 (28 vs. 56)
|
60 (mean)
|
Mild-moderate PNA
|
BL (IV ceftriaxone 1 G X 2/d or IV amoxicillin/ clavulanate 1.2 G X 3/d) vs FQ (PO levofloxacin 500 mg X 2/d)
|
7–10 if favorable response
|
Failure = no clinical response at 72 h
|