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. 2022 Dec 22;4(6):dlac125. doi: 10.1093/jacamr/dlac125

Table 1.

Details for the 10 clinical trials and single retrospective chart review

Author, year, country Trial design, sample size Indication Population Intervention and dosing regimen Efficacy endpoints Efficacy resultsa Safety resultsa
Dunne et al.,52 2020,
not reported		 Prospective randomized comparative trial
N = 1671		 uUTI Adults (age not stated), 100% female

  • Sulopenem: twice daily, 5 days

  • Ciprofloxacin: twice daily, 3 days

  • Overall therapeutic efficacy (defined as a combined clinical and microbiological response of success per subject)

 Overall therapeutic response, test-of-cure visit (mITT)

  • Combined population: n = 339/517 (65.6%) sulopenem versus n = 376/554 (67.9%) ciprofloxacin; difference −2.3% (95% CI: −7.9 to 3.3)

  • Quinolone-non-susceptible population: n = 92/147 (62.6%) sulopenem versus n = 50/139 (36.0%) ciprofloxacin; difference 26.6% (95% CI: 15.1–37.4; P < 0.001)

  • Quinolone-susceptible population: n = 247/370 (66.8%) sulopenem versus n = 326/415 (78.6%) ciprofloxacin; difference −11.8% (95% CI: −18.0 to −5.6)

Overall therapeutic response, end-of-treatment visit (mITT)

  • Combined population: n = 335/517 (64.8%) sulopenem versus n = 313/554 (56.5%) ciprofloxacin; difference 8.3% (95% CI: 2.4–14.1; P = 0.006)

  • Quinolone-non-susceptible population: n = 95/147 (64.6%) sulopenem versus n = 42/139 (30.2%) ciprofloxacin; difference 34.4% (95% CI: 23.1–44.8; P < 0.001)

  • Quinolone-susceptible population: n = 240/370 (64.9%) sulopenem versus n = 271/415 (65.3%) ciprofloxacin; difference −0.4% (95% CI: −7.1 to 6.2)

 AEs

  • Sulopenem: 24.8%

    ciprofloxacin: 13.9%

  • Diarrhoea: 12.4% sulopenem versus 2.5% ciprofloxacin

Drug-related AEs

  • Sulopenem: 17.0%

    ciprofloxacin: 6.2%

SAEs

  • Similar between treatments
Suzuki et al.,49 2016,
Japanb 		Prospective trial
N = 15		 Chronic otitis media Adults (≥20 years), 40% female

  • Faropenem: 300 mg, once daily

  • Not reported

 Not reported AEs

  • 6/15 (40.0%)

  • Diarrhoea: n = 0/15 (0%)

AEs possibly drug related

  • n = 0/15 (0%)

SAEs

  • None
Hamasuna et al.,44 2014,
Japan		 Prospective randomized comparative trial
N = 200		 uUTI Adults (≥20 years), 100% female

  • Faropenem: 200 mg three times a day, 3 days

  • Faropenem: 200 mg three times a day, 7 days

  • Microbiological efficacy (patients with bacterial eradication, persistence and replacedc)

  • Clinical efficacy (success defined as the absence of symptoms)

 Microbiological response, 5–9 days after treatment (ITT)

  • Faropenem 3 days: n = 43/73 (58.9%) eradication, n = 15/73 (20.5%) persistence, n = 6/73 (8.2%) replaced

  • Faropenem 7 days: n = 54/81 (66.7%) eradication, n = 5/81 (6.2%) persistence, n = 6/81 (7.4%) replaced

  • 3 day versus 7 day: P = 0.048

Microbiological response, 4–6 weeks after treatment (ITT)

  • Faropenem 3 days: n = 21/52 (40.4%) eradication, n = 3/52 (5.8%) relapsed, n = 2/52 (3.8%) reinfection

  • Faropenem 7 days: n = 27/70 (38.6%) eradication, n = 4/70 (5.7%) relapsed, n = 3/70 (4.3%) reinfection

  • 3 day versus 7 day: P = 0.839

Clinical response, 5–9 days after treatment (ITT)

  • n = 56/73 (76.7%) faropenem 3 days versus n = 65/81 (80.2%) faropenem 7 days; P = 0.695

Clinical response, 4–6 weeks after treatment (ITT)

  • n = 24/52 (46.2%) faropenem 3 days versus n = 35/70 (50.0%) faropenem 7 days; P = 0.717

 AEs

  • Total: n = 19/200 (9.5%)

  • Faropenem 3 days: n = 10/97 (10.3%)

    faropenem 10 days: n = 9/103 (8.7%)

  • Diarrhoea: n = 10/97 (10.3%) faropenem 3 days versus n = 5/103 (4.9%) faropenem 10 days
Hamasuna et al.,45 2012,
Japan		 Prospective randomized comparative trial
N = 200		 uUTI Adults (≥20 years), 100% female

  • Faropenem: 200 mg three times a day, 3 days

  • Faropenem: 200 mg three times a day, 7 days

  • Microbiological efficacy outcome (patients with bacterial eradication, persistence and replacedc)

  • Clinical efficacy (success not defined)

 Microbiological response, 5–9 days after treatment

  • Faropenem 3 days: n = 39/62 (62.9%) eradication, n = 15/62 (24.2%) persistence, n = 8/62 (12.9%) replaced

  • Faropenem 7 days: n = 54/64 (84.4%) eradication, n = 5/64 (7.8%) persistence, n = 5/64 (7.8%) replaced

  • 3 day versus 7 day: P = 0.018

Clinical response, 5–9 days after treatment

  • n = 57/69 (82.6%) faropenem 3 days versus n = 66/71 (93.0%) faropenem 7 days; P = 0.061

 Not reported
Yokota et al.,51 2008,
Japanb 		Prospective trial
N = 112		 RTI, otitis media or uUTI Paediatric (<16 years), 49% female

  • Faropenem: 15–30 mg/kg/day, 3–8 days

  • Clinical efficacy [defined as ratings of ‘Markedly effective’ and ‘Effective’ based on changes in subjective symptoms and objective findings (not defined)]

  • Microbiological efficacy (success was defined as patients with bacterial eradication)

 Clinical response, by disease (PP)

  • Total: n = 91/100 (91.0%)

  • Upper RTI: n = 63/70 (90.0%)

  • Bronchitis: n = 6/7 (85.7%)

  • Otitis media: n = 16/17 (94.1%)

  • UTI: n = 6/6 (100%)

Clinical response, by pathogen (PP)

  • Total: n = 134/152 (88.2%)

  • Streptococcus pyogenes: n = 42/47 (89.4%)

  • Streptococcus pneumoniae: n = 25/27 (92.6%)

  • Haemophilus influenzae: n = 43/50 (86.0%)

  • Moraxella catarrhalis: n = 18/22 (81.8%)

  • E. coli: n = 6/6 (100%)

Microbiological response (PP)

  • Total: n = 74/108 (68.5%)

  • S. pyogenes: n = 36/40 (90.0%)

  • S. pneumoniae: n = 13/16 (81.3%)

  • H. influenzae: n = 13/33 (39.4%)

  • M. catarrhalis: n = 6/13 (46.2%)

  • E. coli: n = 6/6 (100%)

 AEs

  • n = 14/112 (12.5%)

  • Diarrhoea: n = 14/112 (12.5%)
Upchurch et al.,50 2006,
USA, Canada		 Prospective randomized comparative trial
N = 1099		 Acute bacterial sinusitis Adults (≥18 years), 56% female

  • Faropenem: 300 mg twice daily, 7 days

  • Faropenem: 300 mg twice daily, 10 days

  • Cefuroxime: 250 mg twice daily, 7 days

  • Clinical efficacy (success defined as resolution or improvement of signs and symptoms and no requirement for further antimicrobial therapy)

 Clinical response, 7–21 days after treatment (ITT)

  • n = 262/366 (71.6%) faropenem 7 days versus n = 255/363 (70.2%) faropenem 10 days versus n = 250/370 (67.6%) cefuroxime

  • 95% CI for difference from cefuroxime: faropenem 7 days: −2.7 to 10.5; faropenem 10 days: −3.9 to 9.5

Clinical response, 28–38 days after treatment (ITT)

  • n = 237/366 (64.8%) faropenem 7 days versus n = 230/363 (63.4%) faropenem 10 days versus n = 222/370 (60.0%) cefuroxime

 AEs

  • Faropenem 7 days: n = 141/366 (38.5%)

    faropenem 10 days: n = 124/363 (34.2%) cefuroxime: 150/370 (40.5%)

  • Gastrointestinal: 17% faropenem 7 days versus 14% faropenem 10 days versus 18% cefuroxime

Drug-related AEs

  • Faropenem 7 days: n = 81/366 (22.1%)

    faropenem 10 days: n = 73/363 (20.1%) cefuroxime: n = 69/370 (18.6%)

  • Diarrhoea: 8% faropenem 7 days versus 4% faropenem 10 days versus 4% cefuroxime

SAEs

  • Faropenem 7 days: n = 1/366 (0.3%)

    faropenem 10 days: n = 2/363 (0.6%) cefuroxime: n = 6/370 (1.6%) (all drug unrelated)
Siegert et al.,48 2003,
France, Germany, Greece, Israel, Lithuania, Spain, Sweden		 Prospective randomized comparative trial
N = 561		 Acute bacterial sinusitis Adults (≥18 years), 57% female

  • Faropenem: 300 mg twice daily, 7 days

  • Cefuroxime: 250 mg twice daily, 7 days

  • Clinical efficacy (success defined as disappearance of signs and symptoms, or significant improvement and not further therapy)

  • Microbiological efficacy (success defined as patients with bacterial eradication or presumed eradication)

 Clinical response, 7–16 days after treatment (PP)

  • n = 203/228 (89.0%) faropenem versus n = 198/224 (88.4%) cefuroxime; 95% CI: −5.2 to 6.4

Clinical response, 28–35 days after treatmentd (PP)

  • n = 188/203 (92.6%) faropenem versus n = 188/198 (95.0%) cefuroxime; 95% CI: −5.8 to 1.0

Microbiological response, 7–16 days after treatment (PP)

  • n = 65/71 (91.5%) faropenem versus n = 59/65 (90.8%) cefuroxime; 95% CI: −9.2 to 9.5

Microbiological response, 7–16 days after treatment, by pathogen (PP)

  • M. catarrhalis: n = 6/6 (100%) faropenem versus n = 5/6 (83.3%) cefuroxime

  • S. pneumoniae: n = 36/37 (97.3%) faropenem versus n = 26/27 (96.3%) cefuroxime

  • Staphylococcus aureus: n = 33/38 (86.8%) faropenem versus n = 38/42 (90.5%) cefuroxime

  • H. influenzae: n = 17/20 (85%) faropenem versus n = 19/21 (90.5%) cefuroxime

 AEs

  • Total: n = 95/547 (17.4%)

    faropenem: n = 46/274 (16.8%)

    cefuroxime: n = 49/273 (17.9%)

  • Digestive: n = 15/274 (5.5%) faropenem versus n = 18/273 (6.6%) cefuroxime

Drug-related AEs

  • Faropenem: n = 26/274 (9.5%)

    cefuroxime: n = 28/273 (10.3%)

  • Diarrhoea: n = 6/274 (2.2%) faropenem versus n = 8/273 (2.9%) cefuroxime
Muratani et al.,46 2002,
Japanb 		Prospective comparative trial
N = 90		 cUTI Adults (≥16 years), 20% female

  • Faropenem: 300 mg three times a day, 7 days

  • Levofloxacin: 100 mg three times a day, 7 days

  • Clinical efficacy (overall response, defined as a complete or partial response based on change in bacteriuria and pyuria)

  • Microbiological efficacy (success defined as patients with bacterial eradication)

 Clinical response, 7 days after treatment (PP)

  • All UTI: n = 29/32 (90.6%) faropenem versus n = 23/28 (82.1%) levofloxacin; P = NS

  • Polymicrobial infection: n = 9/11 (81.8%) faropenem versus n = 8/10 (80.0%) levofloxacin; P = NS

Microbiological response, 7 days after treatment (PP)

  • Bacterial eradication: n = 40/46 (87.0%) faropenem versus n = 33/40 (82.5%) levofloxacin; P = NS

  • Bacterial persistence: n = 5/32 (15.6%) faropenem versus n = 6/28 (21.4%) levofloxacin

  • Bacterial strains newly appearing: n = 5/32 (15.6%) faropenem versus n = 5/28 (17.9%) levofloxacin

Microbiological response, by pathogen (PP)

  • Gram-positive bacteria: n = 21/24 (87.5%) faropenem versus n = 12/16 (75.0%) levofloxacin

    • MRSA: n = 0/1 (0%) faropenem versus n = 1/1 (100%) levofloxacin

    • Staphylococcus epidermis: n = 3/3 (100%) faropenem versus n = 1/1 (100%) levofloxacin

    • Staphylococcus saprophyticus: n = 1/1 (100%) faropenem

    • Staphylococcus sp.: n = 4/6 (66.7%) faropenem versus n = 4/6 (66.7%) levofloxacin

    • Streptococcus agalactiae: n = 2/2 (100%) faropenem versus n = 1/1 (100%) levofloxacin

    • Streptococcus bovis: n = 1/1 (100%) faropenem versus n = 1/1 (100%) levofloxacin

    • Streptococcus sp.: n = 3/3 (100%) faropenem versus n = 2/2 (100%) levofloxacin

    • Aerococcus sp.: n = 0/1 (0%) levofloxacin

    • Enterococcus faecalis: n = 7/7 (100%) faropenem versus n = 1/2 (50%) levofloxacin

    • Enterococcus gallinarum: n = 1/1 (100%) levofloxacin

  • Enterobacteriaceae: n = 15/18 (83.3%) faropenem versus n = 19/21 (90.5%) levofloxacin

    • Citrobacter braakii: n = 1/1 (100%) faropenem

    • Citrobacter koseri: n = 3/3 (100%) levofloxacin

    • Enterobacter aerogenes: n = 1/1 (100%) levofloxacin

    • Enterobacter cloacae: n = 2/2 (100%) faropenem

    • E. coli: n = 9/11 (81.8%) faropenem versus n = 11/13 (84.6%) levofloxacin

    • Escherichia hermannii: n = 1/1 (100%) levofloxacin

    • K. pneumoniae: n = 2/2 (100%) faropenem versus n = 2/2 (100%) levofloxacin

    • Proteus mirabilis: n = 1/1 (100%) levofloxacin

    • M. morganii: n = 0/1 (0%) faropenem

    • Other Gram-negative rods: n = 1/1 (100%) faropenem

  • Glucose non-fermentable Gram-negative rods: n = 4/4 (100%) faropenem versus n = 2/3 (66.7%) levofloxacin

    • P. aeruginosa: n = 0/1 (0%) levofloxacin

    • Pseudomonas fluorescens: n = 1/1 (100%) levofloxacin

    • Alcaligenes faecalis: n = 1/1 (100%) faropenem

    • Acinetobacter baumannii: n = 1/1 (100%) faropenem

    • Acinetobacter lwoffii: n = 1/1 (100%) faropenem

    • Stenotrophomonas maltophilia: n = 1/1 (100%) faropenem versus n = 1/1 (100%) levofloxacin

 AEs

  • Total: n = 2/84 (2.4%)

    faropenem: n = 2/52 (3.8%)

    levofloxacin: n = 0/32 (0%)

  • Diarrhoea: n = 2/52 (3.8%) faropenem versus n = 0/32 (0%) levofloxacin

AEs possibly drug related

  • Faropenem: n = 2/52 (3.8%)
Shiba et al.,47 2002,
Japanb 		Prospective trial
N = 17		 RTI or uUTI Adults (≥65 years), 41% female

  • Faropenem: 150 mg three times a day, 4–8 days

  • Not reported

 Not reported AEs

  • n = 5/17 (29.4%)

  • Diarrhoea: n = 2/17 (5.9%)

AEs possibly drug related

  • n = 3/17 (17.6%)
Fujii et al.,43 1997,
Japanb 		Prospective trial
N = 628		 RTI, uUTI, otitis media Paediatric (<16 years), 45% female

  • Faropenem: 3–5–10 mg/kg three times a day, 3–14 days

  • Clinical efficacy [ratings of ‘Excellent’ and ‘Good’ based on improvement of subjective and objective findings (not defined)]

  • Microbiological efficacy (success defined as number of bacterial strains eradicated)

 Clinical response, by diagnosis (PP)

  • Total: n = 456/494 (92.3%)

Patients with an isolate

  • All respiratory infections: 90.5%–100%

  • uUTI: n = 41/41 (100%)

  • Otitis media: n = 15/21 (71.4%)

Patients without an isolate

  • All respiratory infections: 87.5%–100%

  • uUTI: n = 10/10 (100%)

  • Otitis media: n = 10/14 (71.4%)

Clinical response, by midpoint dose (PP)

  • 3 mg/kg three times a day: n = 14/16 (87.5%)

    5 mg/kg three times a day: n = 213/228 (93.4%)

    7.5 mg/kg three times a day: n = 128/139 (92.1%)

    10 mg/kg three times a day: n = 92/102 (90.2%)

Clinical response, by pathogen (PP)

  • S. aureus: n = 55/65 (84.6%)

  • S. epidermidis: n = 2/2 (100%)

  • CoNS: n = 4/4 (100%)

  • S. pyogenes: n = 64/67 (96.6%)

  • S. pneumoniae: n = 23/25 (92.0%)

  • Group A β-Streptococcus: n = 6/7 (85.7%)

  • E. faecalis: n = 3/3 (100%)

  • M. catarrhalis: n = 5/6 (83.3%)

  • E. coli: n = 32/32 (100%)

  • Salmonella enteritidis: n = 2/2 (100%)

  • S. typhimurium: n = 1/1 (100%)

  • Salmonella spp.: n = 2/2 (100%)

  • K. pneumoniae: n = 1/1 (100%)

  • S. marcescens: n = 1/1 (100%)

  • H. influenzae: n = 32/34 (94.1%)

  • Haemophilus parainfluenzae: n = 5/6 (83.3%)

  • Bordetella pertussis: n = 3/3 (100%)

  • Campylobacter jejuni: n = 2/2 (100%)

  • Glucose non-fermenting Gram-negative rods: n = 1/1 (100%)

Microbiological response (PP)

  • Total: n = 250/303 (82.5%)

  • Gram-positive: n = 162/188 (86.2%)

  • Gram-negative: n = 88/115 (76.5%)

Microbiological response, by pathogen (PP)

  • S. aureus: n = 57/54 (77.0%)

  • S. epidermidis: n = 2/2 (100%)

  • CoNS: n = 4/4 (100%)

  • S. pyogenes: n = 64/68 (94.1%)

  • S. pneumoniae: n = 23/28 (82.1%)

  • Streptococcus sanguis: n = 1/1 (100%)

  • Group A β-Streptococcus: n = 4/4 (100%)

  • Group G Streptococcus: n = 1/1 (100%)

  • E. faecalis: n = 6/6 (100%)

  • M. catarrhalis: n = 6/10 (60.0%)

  • E. coli: n = 29/31 (93.5%)

  • Citrobacter freundii: n = 1/1 (100%)

  • S. typhimurium: n = 1/1 (100%)

  • S. enteritidis: n = 0/2 (0%)

  • Salmonella spp.: n = 2/2 (100%)

  • K. pneumoniae: n = 1/1 (100%)

  • S. marcescens: n = 1/1 (100%)

  • P. mirabilis: n = 1/1 (100%)

  • H. influenzae: n = 37/51 (72.5%)

  • H. parainfluenzae: n = 5/9 (55.6%)

  • B. pertussis: n = 2/2 (100%)

  • C. jejuni: n = 1/2 (50.0%)

  • Glucose non-fermenting Gram-negative rods: n = 1/1 (100%)

 AEs

  • n = 36/548 (6.6%)

  • Diarrhoea: n = 32/548 (5.8%)

SAEs

  • None
Fujino et al.,54 2017,
Japan		 Retrospective chart review
N = 10		 uUTI or cUTI Adults (24–86 years), 80% female

  • Faropenem: 200 mg three times a day, 7 days

  • Clinical efficacy (success defined as the resolution of all symptoms with no pyuria)

 Clinical response

  • n = 9/10 (90.0%)

Recurrenced

  • n = 3/9 (33.3%)

 Not reported

AE, adverse event; mITT, modified ITT; NS, not significant; RTI, respiratory tract infection; SAE, serious adverse event.

a

Unless otherwise indicated, data are the number (%) of patients.

b

Japanese-language article, for which full-text translation to English was obtained.

c

The meaning of the term ‘replaced’ is not defined in the source article.

d

Based on the number of patients who showed an initial clinical response as the denominator.