2023-510191-31-00撤回3 期
PROSTABACT : Relevance of the treatment with antibiotics before endoscopic surgery of lower urinary symptoms related to prostate hypertrophy with polymicrobial bacterial culture performed before the surgery: a non-inferiority randomized trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 380
- 试验地点
- 13
- 主要终点
- Incidence over a one-month post-operative period of a symptomatic urinary infection defined by the presence of symptoms validated by a blinded independent adjudication committee (urine burning, fever, urgencies… associated to a significant bacteriuria).
研究概览
简要总结
To demonstrate that not treating a patient with a polymicrobial UBC performed before BPH surgery is not inferior to treating him with antibiotic in terms of urinary tract infection incidence over a one-month post-surgery period.
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow-up 2
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult men ≥ 18 years of age
- •Person affiliated to a French social security system or equivalent
- •Written informed consent obtained from the participant
- •Scheduled to have a surgery of lower urinary Tract Symptoms (LUTS) due to BPH, (Urolift, rezum, aquabeam, monopolar or bipolar Trans-uretral resection of the prostate, enucleation of the prostate (Holep, Greenlep, bipolep), simple prostatectomy)
- •With polymicrobial pre-operative urine culture (three or more pathogens identified).
- •Able to comply with the requirements of the study
- •Patients able to understand this clinical research
排除标准
- •Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: persons deprived of their liberty by judicial or administrative decision and persons subject to a legal protection measure: guardianship or trusteeship)
- •Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, known HIV and CD4<200/mm3)
- •Patients already treated by antibiotic for non-urological situations
- •Concomitant participation in other pharmacological study
- •Patients in medical emergency
- •Mental state making the patient unable to understand this research
- •Patient being the investigator as well as any member of the team or close relative of the investigator directly involved in the trial, in particular assistant doctors, pharmacists, nurses, trial coordinator
- •Contraindications to antibiotic drugs administered in this study
- •Infection within 6 months before surgery
- •Hospitalisation within 6 months before surgery
结局指标
主要结局
Incidence over a one-month post-operative period of a symptomatic urinary infection defined by the presence of symptoms validated by a blinded independent adjudication committee (urine burning, fever, urgencies… associated to a significant bacteriuria).
Incidence over a one-month post-operative period of a symptomatic urinary infection defined by the presence of symptoms validated by a blinded independent adjudication committee (urine burning, fever, urgencies… associated to a significant bacteriuria).
次要结局
- Number of patients whose procedure is cancelled in each group
- Probability that the experimental strategy is clinically and economically non-inferior to the control strategy for different values of economic non-inferiority margin and for a constant clinical non-inferiority margin (10%).
- Infection characteristics (type of bacteria, clinical data, hospitalization…)
- Cost of antibiotics used to treat with antibiotics a polymicrobial UBC performed before endoscopic treatments of BPH and in the one-month post-operative surgical treatment
- Economic impact per year and per cumulative years of a change in prescribing practices for polymicrobial UBC before endoscopic surgery of BPH, from the French Health Insurance perspective, over a 5-year period.
- Description of baseline urine microbiota in both groups (patients who developed an infection and patients who did not)
研究者
Pr Franck BRUYERE
Scientific
Centre Hospitalier Regional Universitaire De Tours
研究点 (13)
Loading locations...
相似试验
招募中
2 期
Phase II study on the safety and efficacy of cysteamine in association with standard tuberculosis therapy for the treatment of patients with pulmonary tuberculosis: a new therapy for tuberculosis directed at the host.Pulmonary Tuberculosis2024-516088-10-00National Institute For Infectious Diseases Lazzaro Spallanzani30
招募中
3 期
Research study to look at how well the drug concizumab works in your body if you have haemophilia with inhibitors2023-506832-33-00Novo Nordisk A/S43
招募中
4 期
Efficacy of seven and fourteen days of antibiotic treatment in uncomplicated Staphylococcus aureus bacteremia:
A randomized, non-blinded, non-inferiority interventional study (SAB 7)2024-519186-21-01Hvidovre Hospital264
招募中
4 期
Efficacy and safety of 7 versus 14 days of antibiotic treatment for bacteremia produced by Pseudomonas aeruginosa: a multicenter, randomized (SHORTEN-2) clinical trial with a DOOR/RADAR analysis.2023-508441-41-00Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla306
招募中
4 期
Ursodeoxycolic acid for the prevention of relapsing complications after gallstone acute pancreatitis, a double-blind multicenter randomized-controlled trial.2024-518237-28-00Hospital General Universitario Dr. Balmis332