Antibiotic Prophylaxis Clinical Trial
Official title:
Antibiotic Prophylaxis to Prevent Post-procedure Urinary Tract Infection After Voiding Cystourethrogram
The current practice of pre-VCUG antibiotic prophylaxis is highly variable. A recent unpublished survey of Society of Fetal Urologists (SFU) completed by this study team found that 87% of respondents reported having patients who develop fUTI following VCUG, with 30% of respondents prophylaxing for fUTI in patients undergoing VCUG. The current lack of best practice guidelines regarding antibiotic prophylaxis prior to VCUG due to low quality of current literature, and a growing concern around risks of unnecessary antibiotic exposure suggests the need for an RCT. The results of this pilot trial will inform the ability to conduct a definitive RCT on this important subject. The results of the definitive trial would have important clinical and economic implications.
What are the Study Objectives? The primary objective of this pilot trial is to determine the feasibility of conducting a definitive trial investigating whether pre-VCUG antibiotic prophylaxis, when compared to placebo, decreases the risk of fUTI in infants undergoing VCUG for genitourinary abnormalities. The pilot trial will address specific feasibility outcomes including process, resources, management and scientific domains. The pilot will lay the groundwork for the eventual full trial. Funding for the full trial will be sought after preliminary data is collected from the pilot study. The primary objective for the definitive trial is to determine whether single-dose, preprocedural antibiotic prophylaxis compared to placebo lowers the risk of fUTI in children < 3 years of age who are undergoing VCUG for the following indications: high-grade (SFU Classification III, IV/UTD 2,3) HN, ureteral dilatation, or bladder abnormalities found during renal ultrasound. The secondary outcomes of the definitive trial will include assessment of adverse event outcomes related to antibiotic prophylaxis administration, including antibiotic resistant UTI pathogens, episodes of antibiotic associated diarrhea, and C. difficile. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03028129 -
Prevention of Tuberculosis in Prisons
|
Phase 4 | |
| Completed |
NCT05612542 -
Pediatric Cardiac Surgery Comparing Short 24-hour Antibiotic Prophylaxis to Extended Antibiotic Prophylaxis
|
||
| Completed |
NCT03765645 -
Comparison of 9 Doses vs 3 Doses of Post Operative Antibiotics in Live Liver Donors
|
N/A | |
| Completed |
NCT03306290 -
Serum Concentration of CEFOxitin Used for Antibiotic Prophylaxis in Obese Patients Undergoing BARiatric Surgery
|
N/A | |
| Recruiting |
NCT03283878 -
Antibiotic Prophylaxis in Patients Undergoing Elective TKA- Multi-center Trial
|
Phase 4 | |
| Recruiting |
NCT05654896 -
Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma
|
Phase 3 | |
| Recruiting |
NCT05609240 -
Colo-Pro_2: Bolus-continuous Infusion Cefuroxime Prophylaxis for the Prevention of Infections After Colorectal Surgery
|
Phase 2 | |
| Withdrawn |
NCT04280237 -
Pharmacological Study of Cefazolin Antibioprophylaxis in Liver Transplantation
|
||
| Completed |
NCT02479503 -
Antibiotic Prophylaxis in Adult Heart Transplantation: a French National Survey
|
||
| Completed |
NCT00818766 -
Efficacy of Post-operative Antibiotic Prophylaxis for Thoracic Surgery Requiring Tube Thoracostomy.
|
N/A | |
| Recruiting |
NCT05755789 -
Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery
|
Phase 3 | |
| Withdrawn |
NCT01880112 -
Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery.
|
Phase 4 | |
| Withdrawn |
NCT03982810 -
The Role of Guideline-adherent Perioperative Antibiotic Administration and the Risk of Surgical Site Infections After Non-cardiac Surgery.
|
||
| Recruiting |
NCT03269604 -
Effectiveness of Three Times of Starting Antibiotic Prophylaxis in Patients With Asymptomatic Bacteriuria.
|
N/A | |
| Terminated |
NCT03386227 -
Prophylactic Antibiotics Prior to Embryo Transfer (PAPET): RCT
|
N/A | |
| Completed |
NCT02809729 -
Antibiotic Prophylaxis in Oncological Surgery of Breast
|
N/A | |
| Completed |
NCT03412305 -
The Effect of Antibiotic Prophylaxis Associated With Dental Implant Surgery
|
Phase 4 | |
| Completed |
NCT03790254 -
D Mannose for Prevention and Treatment of RUTIs
|
||
| Recruiting |
NCT05519072 -
Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA
|
Phase 4 | |
| Not yet recruiting |
NCT05813184 -
Prenatal Antibiotics and Breast Milk / Neonatal IgA
|