Study | Study Period; Publication Year | Design | Location | Funding Source | Enrolled Patientsa; ITT | Age (years) | PNA Characteristics | Antibiotic Regimena | Duration of Therapy (days) | Outcomes Definitions |
---|---|---|---|---|---|---|---|---|---|---|
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 |