An Early Phase 1 interventional study of levofloxacin and Nitrofurantoin in Complication of Surgical Procedure, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-10-01.
Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Early Phase 1, Interventional, and Prevention
Minimally invasive upper tract lithotomy is currently a common operation method on treatment of urinary tract stones, but the postoperative complication urinary tract infection or urinary sepsis has turned into a serious threat to the patient's life, when severe, can result in a higher death rate.Although more the more importance were attached to, an effective prevention measures still have not been found.
Among Urinary calculi, the higher rates of infection stone resulted in a higher incidence of postoperative urinary tract infection. The conventional postoperative prophylaxis medicine was the use of antimicrobial drugs half an hour before surgery.Foreign studies had shown that continuous preoperative one week use of nitrofurantoin can significantly reduce the incidence of urinary sepsis. So the investigators assume that preoperative extended use time of prophylaxis antibiotic may reduce the incidence of urinary tract infection or urinary sepsis.
This study uses a computerized random method. According to preoperative use of different antimicrobial drug or treatment, all patients are randomly divided into five groups, namely levofloxacin 3days group,levofloxacin 7days group, nitrofurantoin 3days group,nitrofurantoin 7days group and cefuroxime group.The levofloxacin group receives levofloxacin 0.5g, qd, po, the nitrofurantoin group was given oral nitrofurantoin 100mg, tid, po.to explore the better antibiotics types, medication timing and duration of treatment to prevent postoperative infection after minimally invasive upper tract lithotomy, so as to reduce the incidence of postoperative urinary tract infection or sepsis.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 150 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 222 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
There are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives levofloxacin 0.5g,qd,po 3 days before Minimally invasive upper tract lithotomy.
Drug: levofloxacin · Drug: cefuroxime
There are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives nitrofurantoin 0.1g, tid, po 3 days before Minimally invasive upper tract lithotomy.
Drug: Nitrofurantoin · Drug: cefuroxime
There are 150 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and does not receive oral antibiotics 7 days before Minimally invasive upper tract lithotomy.All patients in all groups, 30 minutes before surgery, are given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours.
Drug: cefuroxime
There are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives levofloxacin 0.5g,qd,po 7 days before Minimally invasive upper tract lithotomy.
Drug: levofloxacin · Drug: cefuroxime
There are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives nitrofurantoin 0.1g, tid, po 7 days before Minimally invasive upper tract lithotomy.
Drug: Nitrofurantoin · Drug: cefuroxime
There are 50 patients in the group,each patient receives levofloxacin 0.5g, qd, po 7 days before Minimally invasive upper tract lithotomy.All patients in all groups, 30 minutes before surgery, are given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours.
Also known as: Cravit
There are 50 patients in the group,each patient receives nitrofurantoin 0.1g, qd, po 7 days before Minimally invasive upper tract lithotomy.All patients in all groups, 30 minutes before surgery, are given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours.
Also known as: Furadantin
There are 150 patients in the group, 30 minutes before surgery, each patient is given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours.
Also known as: zinacef
Evidence of clinically urinary tract infection confirmed by laboratory examination or urine bacterial culture.
Compared with control group, the positive rate of operative blood routine, CRP, urine routine, urine culture, procalcitonin , bacterial endotoxin test of experimental group are declining.
Time frame: 3 or 7 days after operation
Evidence of clinically urosepsis confirmed by laboratory examination, urine bacterial culture, and vital signs
Compared with control group, the positive rate of operative blood culture, procalcitonin are declining.
Time frame: 3 or 7 days after operation
Plan to share: Undecided
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine