Clinical Trials Logo

Clinical Trial Summary

Febrile urinary tract infections and urosepsis are common and potentially serious infections that require effective antimicrobial treatment. The duration of parenteral treatment depends on oral alternatives. These alternatives are few and due to antimicrobial resistance, quinolones are "standard of care". The increased use of quinolones is concerning because of its negative ecological aspects and it is confirmed an increasing incidence of resistant E.coli to quinolones in Norwegian isolates.

Pivmecillinam is an antibiotic with high susceptibility to E.coli but the evidence for treating febrile urinary tract infections is insufficient. This trial will investigate the efficacy and safety of pivmecillinam in treating pyelonephritis and urosepsis caused by E.coli.

The hypothesis is that urosepsis can safely be treated with pivmecillinam when it is given after 2-3 days with empirical i.v. antibiotics.


Clinical Trial Description

This trial will be conducted at Vestfold Hospital, Norway, and is a prospective observational study with intention to treat. Participants will be consecutively included among hospitalized patients suffering from urosepsis - see eligibility criteria. After 3 days with parenteral antibiotics, when clinical improvement and absence of fever/leukocytosis is confirmed, the participants will start on pivmecillinam 400mg four times daily and be discharged. Pivmecillinam is to be taken for one week. The participants will be contacted by phone on day 4, 10 and 33 (days after admission). On day 17 (test of cure, TOC) they will meet for physical examination. They will report symptom score (standardized schema) on day 0, and 17. Urine samples will be collected on day 10 and 17. Blood samples on day 17. All data will be stored anonymously. The trial will be monitored by extern resources. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03282006
Study type Interventional
Source Sykehuset i Vestfold HF
Contact
Status Completed
Phase Phase 4
Start date September 29, 2017
Completion date April 21, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT04495699 - Asymptomatic Renal Calculi in Recurrent Urinary Tract Infections
Terminated NCT05254808 - EXtended Use of FOsfomycin for the Treatment of CYstitis in Primary Care Phase 3
Completed NCT03680612 - Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI Phase 2
Completed NCT03526484 - The Utility of Urinalysis Prior to In-Office Procedures N/A
Completed NCT05397782 - Effects of Flourish on Recurrent Urinary Tract Infection N/A
Completed NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03687255 - Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections Phase 3
Recruiting NCT05227937 - Single Dose Amikacin for Uncomplicated Cystitis in the ED: A Feasibility Study
Completed NCT02864420 - Hospitalization at Home: The Acute Care Home Hospital Program for Adults N/A
Completed NCT03131609 - Avoiding Bacterial Contamination of Clean Catch Urine Cultures in Ambulatory Patients in the Emergency Department
Completed NCT01911143 - A Retrospective, Blinded Validation of a Host-response Based Diagnostics N/A
Completed NCT01333254 - A Trial of Different Methods for Bladder Drainage in Hip Surgery Patients N/A
Terminated NCT00594594 - Adjuntive Probiotic Therapy in Treating Urinary Tract Infections in Spinal Cord Injury Phase 1
Completed NCT00216853 - A Study of Vaginal MicroFlora and Immune Profiles of Patients With Recurrent Urinary Tract Infection N/A
Completed NCT00787085 - The Significance of Funguria in Hospitalized Patients N/A
Completed NCT05719753 - The Effectiveness of a Bacteriophobic Coating on Urinary Catheters N/A
Recruiting NCT05415865 - The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder Phase 3
Not yet recruiting NCT05880329 - DIagnoSing Care hOme UTI Study
Recruiting NCT04615065 - Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
Completed NCT03970356 - Improving Antibiotic Prescribing for Urinary Tract Infections in Frail Elderly N/A