Study Name
duration, location
funding

Study Design,

Sample size
completed study/group total

Follow up

Intervention
dose, route, frequency, duration

Participant Characteristics

Age: mean (SD), [range]

Sex: number (%)

Race: number (%)

Prior liver conditions, alcohol abuse, diabetes

ALF

number, (%)

Type

Authors’ reported conclusion

Leophonte 2004 [48]

September 1998 - July 1999,

102 centers in France, Poland and South Africa

Funding not reported

Multicenter, double-blind, randomized, active controlled, parallel-group trial

Gemifloxacin:134/167

Amoxicillin/Clavulanic Acid: 120/153

Follow up:
24-30 days after end of treatment

Gemifloxacin
320 mg, oral,
once/day (qd),
7 days

Persons 18 years or older, diagnosed with bacterial community acquired pneumonia (CAP), and showing fever and at least 2 of the following:

• New or increased cough,

• Purulent sputum or a change in sputum characteristics,

• Rales and/or evidence of pulmonary consolidation, or

• Dyspnea

Gemifloxacin:
53.3 (20.4)
[18-97] years

Men: 107 (64.1%)

Caucasian: 138 (82.6%)

Not reported

Gemifloxacin: 1 (1%) Hepatocellular damage:

Gemifloxacin is well tolerated and is an effective alternative to amoxicillin/clavulanic acid and offers a more convenient dosing regimen

Amoxicillin/Clavulanic Acid
1 g/125 mg,
oral,
3 times/day (tid),
10 days

Amoxicillin/Clavulanic Acid:
55.3 (19.8)
Range: 18-87

Men: 96 (62.7%)

Caucasian: 120 (78.4%)

Amoxicillin/Clavulanic Acid: 2 (1%) Hepatocellular damage:

NCT00492726 2007 [49]

July 2006 - February 2009

52 centers in Argentina, Belgium, Bulgaria, Estonia, France, Germany, Greece, Israel, Latvia, Lithuania, Romania, Russia, South Africa, and Spain

Bayer HealthCare AG

Prospective, randomised, double-dummy, double-blind, multicenter, non-inferiority study

Moxifloxacin: 408/430

Ertapenem: 380/394

Follow up:

21-28 days after end of treatment

Moxifloxacin: 400 mg IV once daily (qd) placebo for 30 min immediately followed by moxifloxacin 400 mg in 250 mL over 60 min every 24 h 5-14 days

Patients who are ≥ 18 years with a confirmed or suspected complicated intraabdominal infection (cIAI requiring surgery and parenteral antibiotic therapy

Moxifloxacin:

46.7 (17.8)

Men: 218 (61.9 %)

Race: Not reported

Prior liver conditions:

No history of severe hepatic insufficiency (Child-Pugh C)

Alcohol & diabetes: Not reported

Moxifloxacin:

1 (0.25%) Acute liver failure

Hepatotoxicity and cardiac toxicity were not observed witheither moxifloxacin or ertapenem therapy.