A Phase 4 interventional study of pivmecillinam in Pyelonephritis and Urinary Tract Infections, sponsored by Sykehuset i Vestfold HF. Completed at 1 site in Norway. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2020-04-22.
Sponsored by Sykehuset i Vestfold HF · Phase 4, Interventional, and Treatment
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.
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.
79 studies on the registry are indexed under Pyelonephritis; 12 are open to participants now.
This study's enrollment of 53 is below the median of 175 across 62 interventional studies indexed under Pyelonephritis.
Browse Pyelonephritis studies →Sykehuset i Vestfold HF is the lead sponsor of 23 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients treated with pivmecillinam
Drug: pivmecillinam
Oral treatment of bacteremic pyelonephritis following standard initial parenteral treatment
Also known as: Selexid, Penomax
Clinical efficacy
Defined as abscence of fever, no need for other antibiotics than prescribed and improvement of symptoms (self-reported improvement and EQ 5D VAS-scale).
Time frame: Day 17
C-reactive protein-level (CRP)
Compare CRP-level on day 0 with day 17.
Time frame: Day 17
Readmission due to urinary tract infection (UTI)
Check if participants are readmitted due to UTI.
Time frame: Day 33
Readmission - any cause
Check if participants have been readmitted to hospital
Time frame: Day 33
Adverse effects
Registrate frequency of rash/skin problems, abdominal pain, clostridium difficile associated diarrhea
Time frame: Day 33
Microbial efficacy
Defined as \<1.000 CFU E.coli in urine
Time frame: Day 17
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Sykehuset i Vestfold HF