Treating Pyelonephritis an Urosepsis With Pivmecillinam (MePUr)
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|ClinicalTrials.gov Identifier: NCT03282006|
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : October 26, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Pyelonephritis Urinary Tract Infections||Drug: pivmecillinam||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy and Safety of Pivmecillinam in Treating Bacteriemic Urosepsis Caused by E.Coli|
|Actual Study Start Date :||September 29, 2017|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||March 2019|
Patients treated with pivmecillinam
Oral treatment of bacteremic pyelonephritis following standard initial parenteral treatment
Other Name: Selexid, Penomax
- Clinical efficacy [ Time Frame: Day 17 ]Defined as abscence of fever, no need for other antibiotics than prescribed and improvement of symptoms (EQ 5D).
- C-reactive protein-level (CRP) [ Time Frame: Day 17 ]Compare CRP-level on day 0 with day 17.
- Readmission due to urinary tract infection (UTI) [ Time Frame: Day 33 ]Check if participants are readmitted due to UTI.
- Readmission - any cause [ Time Frame: Day 33 ]Check if participants have been readmitted to hospital
- Adverse effects [ Time Frame: Day 33 ]Registrate frequency of rash/skin problems, abdominal pain, clostridium difficile associated diarrhea
- Microbial efficacy [ Time Frame: Day 17 ]Defined as <1.000 CFU E.coli in urine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282006
|Contact: Tore Stenstad, MD, PhDfirstname.lastname@example.org|
|Contact: Bjørn Å Hansen, MDemail@example.com|
|Vestfold Hospital Trust||Recruiting|
|Tønsberg, Vestfold, Norway, 3103|
|Contact: Tore Stenstad, PhD +004733342000 firstname.lastname@example.org|
|Contact: Bjørn Åsheim Hansen, MD +004733342000 email@example.com|
|Principal Investigator:||Tore Stenstad, MD, PhD||The Hospital of Vestfold|