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The Preventive Urinary Tract Infection Role of One Week Solutions of Antimicrobial Application Before Minimally Invasive Upper Tract Lithotomy

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Ce qui est testé

levofloxacin

+ cefuroxime

+ Nitrofurantoin

Médicament
Qui peut participer

Maladies génito-urinaires+4

+ Maladies urogénitales féminines et complications de la grossesse

+ Infections

De 16 à 75 ans
+12 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude de prévention

Phase 1 précoce
Interventionnel
Date de début : septembre 2016
Voir le détail du protocole

Résumé

Sponsor principalXinhua Hospital, Shanghai Jiao Tong University School of Medicine
Contacts de l'étudeLi lixia, MasterVoir plus de contacts
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 septembre 2016

Date à laquelle le premier participant a commencé l'étude.

1. Sample Calculation: Based on the literature, the occurrence rate of fever after Percutaneous Nephrolithotripsy (PCNL) was 21% -39.8%, urinary tract infection rate 38%, SIRS rate 11.2%, the incidence rate of urinary sepsis 0.3% - 4.7%,and the mortality rate with sepsis was 60% -80%. Expected incidence rate of urinary tract infection decreased to 23%, and the difference is statistically significant. Provided that the case of the two groups is equal, the expected strength of evidence is 0.9, α = 0.05, the lost up to 20%, the investigators calculated that the minimum sample size required is 150 cases. Urology department has 70 ward beds with PCNL surgery or Flexible Ureteroscopy Lithotripsy (FURL) about 400 cases per year, and the sample size can meet the study requirements. All cases are from outpatient or emergency department. 2. Grouping and medication: 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.and each group of levofloxacin group or nitrofurantoin group has been given prophylactic for 3 or 7 days. The levofloxacin group receives levofloxacin 0.5g, qd, po, the nitrofurantoin group was given oral nitrofurantoin 100mg, tid, po. All patients in cefuroxime group, 30 minutes before surgery, are given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours. 3. Sterilization or bacterial culture: Surgical areas is disinfected with 10% povidone-iodine, all surgical instruments are sterilized by high-temperature steam. after renal pelvises are punctured, some urine is extracted for bacterial culture. Stones removed by surgery are fragmented into small fragments, and stored at 36.5 ℃ tubes within a day in order to facilitate the proliferation of bacteria, then grown in culture medium for bacterial culture. 4. Preoperative items observed: urinalysis, urine culture, renal function, blood, CRP, procalcitonin, bacterial endotoxin test, kidney function, body temperature changes prophylactic or preoperative. Imaging tests include urinary tract calculi line pyelography and CT. 5. Postoperative follow-up: urine, urine culture, renal function, blood routine, CRP, procalcitonin, bacterial endotoxin test, renal function and urinary tract stones line urography and CT examination were made in all patients. Vital signs such as body temperature, heart rate and blood pressure once every two hours were monitored in 48 hours, and were monitored every 4 hours after 48 hours. Blood routine was checked daily until 3 days postoperative or 48 hours after abatement of fever. When white blood cell count> 12 × 109 / L and / or body temperature> 38 ℃ °, it is considered to be systemic inflammatory response (SIRS, modified Sepsis Diagnostic Criteria). Renal fistula was retained for 48 hours Postoperative, and pleural effusion fistula was removed if there was no fever after it was pinched 24 hours. 6. Statistical analysis: Statistical Product and Service Solutions (SPSS)19.0 statistical software was used for analysis. Count data were analyzed by analysis of variance or t Test. Measurement data were analyzed by Chi-square Test. The results were evaluated within the safe range of 95%,when P <0.05,it was statistically significant.

Titre officielThe Preventive Urinary Tract Infection Role of One Week Solutions of Antimicrobial Application Before Minimally Invasive Upper Tract Lithotomy
NCT02789579
Sponsor principalXinhua Hospital, Shanghai Jiao Tong University School of Medicine
Contacts de l'étudeLi lixia, MasterVoir plus de contacts
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

150 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Prévention

Cette étude cherche à prévenir l'apparition d'une maladie ou d'un trouble chez des personnes qui ne l'ont pas encore développé. Elles concernent souvent des personnes à risque et testent des vaccins, des changements de mode de vie ou des traitements préventifs.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 16 à 75 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies génito-urinairesMaladies urogénitales féminines et complications de la grossesseInfectionsInfections des voies urinairesMaladies urologiquesMaladies urogénitales masculinesMaladies urogénitales féminines

Critères

Un critère d'inclusion nécessaire pour participer
Clinical diagnosis of urinary tract lithiasis (stones ≥ 2cm) or urolithiasis with hydronephrosis

11 critères d'exclusion empêchent la participation
antimicrobial drugs been administered in the latest month

immunosuppressor been administered in the latest month

urinary tract infection or positive urine culture results

history of urinary calculi surgery

Voir plus de critères

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

5 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
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.

Groupe II

Expérimental
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.

Groupe III

Expérimental
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.

Groupe IV

Expérimental
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.

Groupe 5

Expérimental
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.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Recrutement en cours

Department of Pharmacy, Xinhua Hospital, Shanghai Jiaotong University School of Medicine.Kongjiang Road 1665,

Shanghai, ChinaOuvrir Department of Pharmacy, Xinhua Hospital, Shanghai Jiaotong University School of Medicine.Kongjiang Road 1665, dans Google Maps
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