A multicenter, randomized controlled clinical study on biapenem and imipenem/cilastatin injection in the treatment of respiratory and urinary tract infections.
BACKGROUND
Biapenem is an injectable carbapenem antibiotic. A clinical study was designed to evaluate its efficacy and safety in the treatment of respiratory and urinary infections compared to imipenem/cilastatin.


METHODS
A total of 216 patients with respiratory or urinary tract infections were enrolled into this multicenter, open-label, randomized controlled clinical study. Each patient was randomly assigned to either the treatment or control group; 106 patients in each group were included in the ITT analyses. The patients were given biapenem 300 mg or imipenem/cilastatin 500 mg/500 mg two or three times daily, i.v. g.t.t. for 7-14 days according to their conditions.


RESULTS
The cure and effective rates were 67.92 and 88.68% in the biapenem group and 76.02 and 93.40% in the imipenem/cilastatin group, the bacterial eradication rates were 93.83 and 98.82%, and the adverse-event rates were 6.54 and 7.41%, respectively. There were no significant differences between the two groups (p > 0.05).


CONCLUSIONS
Biapenem is as effective and well-tolerated as imipenem/cilastatin for the treatment of intermediate and severe bacterial infections.
Jia
Bei
B
Infectious Disease Department, First Affiliated Hospital of Chongqing University of Medical Sciences, Chongqing, China. beijia123@sina.com
Lu
Ping
P
Huang
Wenxiang
W
Li
Chongzhi
C
Huang
Ailong
A
Zhou
Xiangdong
X
Zhang
Weili
W
Wu
Guoming
G
Zhang
Genfu
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy / Q000382:microbiology; D015377:Cilastatin / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D000077728:Cilastatin, Imipenem Drug Combination; D004338:Drug Combinations; D005260:Female; D006784:Hospitals, Teaching; D006801:Humans; D015378:Imipenem / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012141:Respiratory Tract Infections / Q000188:drug therapy* / Q000382:microbiology; D013845:Thienamycins / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D014552:Urinary Tract Infections / Q000188:drug therapy* / Q000382:microbiology; D055815:Young Adult
D000890:Anti-Infective Agents; D004338:Drug Combinations; D013845:Thienamycins; D015377:Cilastatin; D015378:Imipenem; D000077728:Cilastatin, Imipenem Drug Combination; C065257:biapenem