Urinary Tract Infections Clinical Trial
— CAPITISOfficial title:
Piperacillin/Tazobactam Versus Carbapenems in Non-bacteremic Urinary Tract Infections Due to Extended-spectrum β-lactamase (ESBL)-Producing Escherichia Coli or Klebsiella Pneumoniae - (CAPITIS Study)
This study evaluates the efficacy in achieving clinical cure in non-bacteremic urinary tract
infections (UTI) caused by Escherichia coli or Klebsiella pneumoniae producers of
extended-spectrum β-lactamases (ESBL) in adult patients. Half of participants will receive
Piperacillin/Tazobactam as treatment, while the other half will receive Carbapenems.
The investigators will verify that Piperacillin/Tazobactam is not inferior in achieving
clinical cure, and that is not associated with a higher risk of adverse events in the
directed treatment of non-bacteremic UTI compared to Carbapenems.
The researchers hope to improve the use of antibiotics in the non-bacteremic UTI, reducing
the "collateral damage" related to a deterioration in the prognosis of patients and the
generation of resistant germs caused by the use of broad-spectrum antibiotics as carbapenems.
Status | Recruiting |
Enrollment | 198 |
Est. completion date | April 1, 2021 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adults (=18 years) with hospital admission for non-bacteremic UTI caused by E. coli or K. pneumoniae ESBL susceptible to piperacillin/tazobactam and carbapenems. - Presence of any risk factor associated with UTI due to ESBL germs: older age 64 years, diabetes mellitus, bladder catheter, previous antibiotics in the last 6 months, hospitalization in the last 6 months, urological surgery in the last 30 days, infections recurrent urinary. - Diagnosis of UTI confirmed by: 1) fever, 2) urine culture> 100000 CFU with isolation E. coli or K. pneumoniae ESBL susceptible to piperacillin / tazobactam and carbapenems, and 3) lumbar and / or abdominal pain with or without low urinary symptoms (dysuria, tenesmus, urgency), and 4) no other cause that explains the patient's symptoms - Signed informed consent. - Negative pregnancy test in fertile women. Exclusion Criteria: - Non-acceptance of participation in the study. - Pregnancy. - Hypersensitivity and/or previous intolerance to penicillins, piperacillin/tazobactam or carbapenems. - Bacteremia, hematogenous infection or other concomitant infection. - Immunosuppression. - In case of obstructive uropathy, lack of early surgical resolution. - Evidence of acute or chronic prostatitis. - Renal abscess - Polycystic disease in the kidneys. - Palliative care or life expectancy <90 days. - Heart failure (NYHA) functional class III or IV. - Liver cirrhosis. - Renal insufficiency in dialysis treatment. - Empirical active treatment against bacteria isolated by urine cultures other than E. coli or K. pneumoniae BLEE. - Participation in another clinical trial for infections. - Hypersensitivity to amide-type local anesthetics. |
Country | Name | City | State |
---|---|---|---|
Colombia | Universidad del Norte´s Hospital | Soledad | Atlantico |
Lead Sponsor | Collaborator |
---|---|
Universidad del Norte |
Colombia,
Harris PNA, Tambyah PA, Lye DC, Mo Y, Lee TH, Yilmaz M, Alenazi TH, Arabi Y, Falcone M, Bassetti M, Righi E, Rogers BA, Kanj S, Bhally H, Iredell J, Mendelson M, Boyles TH, Looke D, Miyakis S, Walls G, Al Khamis M, Zikri A, Crowe A, Ingram P, Daneman N, Griffin P, Athan E, Lorenc P, Baker P, Roberts L, Beatson SA, Peleg AY, Harris-Brown T, Paterson DL; MERINO Trial Investigators and the Australasian Society for Infectious Disease Clinical Research Network (ASID-CRN). Effect of Piperacillin-Tazobactam vs Meropenem on 30-Day Mortality for Patients With E coli or Klebsiella pneumoniae Bloodstream Infection and Ceftriaxone Resistance: A Randomized Clinical Trial. JAMA. 2018 Sep 11;320(10):984-994. doi: 10.1001/jama.2018.12163. — View Citation
Paterson DL, Bonomo RA. Extended-spectrum beta-lactamases: a clinical update. Clin Microbiol Rev. 2005 Oct;18(4):657-86. Review. — View Citation
Pitout JD, Laupland KB. Extended-spectrum beta-lactamase-producing Enterobacteriaceae: an emerging public-health concern. Lancet Infect Dis. 2008 Mar;8(3):159-66. doi: 10.1016/S1473-3099(08)70041-0. Review. — View Citation
Rodríguez-Baño J, Navarro MD, Retamar P, Picón E, Pascual Á; Extended-Spectrum Beta-Lactamases–Red Española de Investigación en Patología Infecciosa/Grupo de Estudio de Infección Hospitalaria Group. ß-Lactam/ß-lactam inhibitor combinations for the treatment of bacteremia due to extended-spectrum ß-lactamase-producing Escherichia coli: a post hoc analysis of prospective cohorts. Clin Infect Dis. 2012 Jan 15;54(2):167-74. doi: 10.1093/cid/cir790. Epub 2011 Nov 4. — View Citation
Rosso-Fernández C, Sojo-Dorado J, Barriga A, Lavín-Alconero L, Palacios Z, López-Hernández I, Merino V, Camean M, Pascual A, Rodríguez-Baño J; FOREST Study Group. Fosfomycin versus meropenem in bacteraemic urinary tract infections caused by extended-spectrum ß-lactamase-producing Escherichia coli (FOREST): study protocol for an investigator-driven randomised controlled trial. BMJ Open. 2015 Mar 31;5(3):e007363. doi: 10.1136/bmjopen-2014-007363. — View Citation
Tamma PD, Rodriguez-Bano J. The Use of Noncarbapenem ß-Lactams for the Treatment of Extended-Spectrum ß-Lactamase Infections. Clin Infect Dis. 2017 Apr 1;64(7):972-980. doi: 10.1093/cid/cix034. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical cure. | Complete resolution of non-bacteremic urinary tract infection signs or symptoms (dysuria, urinary frequency, urinary urgency, suprapubic pain or temperature greater than 38 degrees Celsius) present at trial entry (and no new signs or symptoms) until the duration of investigational antibacterial drug therapy. Investigators will compare the rate of clinical cure between the two treatment lines. |
At 5-7 day after the end of treatment (cure test), or for early response after 5 days from the start of treatment. | |
Secondary | Microbiologic cure. | Clinical cure (primary outcome) and demonstration that the bacterial pathogen found at trial entry is reduced to fewer than 100.000 CFU/mL on control urine culture. Investigators will compare the rate of microbiologic cure between the two treatment lines. |
At the 5-7 day after the end of treatment (cure test). | |
Secondary | Mortality in patient follow-up. | All-cause Mortality Rate in the CAPITIS Study Population (Piperacillin/Tazobactam Versus Carbapenems in Non-bacteremic Urinary Tract Infections Due to Extended-spectrum ß-lactamase (ESBL)-Producing Escherichia Coli or Klebsiella Pneumoniae. | Until day 30 after the first day of administration of the study drugs. | |
Secondary | Length of hospital stay in patient follow-up. | Time since the assignment of the randomization until the patient leaves the hospital. | Until day 30 after the first day of administration of the study drugs. | |
Secondary | Relapse. | Proportion of Subjects in the CAPITIS Study Population with a Relapse (All Indications). Development of non-bacteremic urinary tract infection signs or symptoms (dysuria, urinary frequency, urinary urgency, suprapubic pain or temperature greater than 38 degrees Celsius) in patients with previous clinical and microbiological cure, plus positive urine culture with the same microorganism isolated in initial culture. Investigators will compare the risk of relapse with each regimen. |
Daily until day 30 after the first day of administration of the study drugs. | |
Secondary | Reinfection. | Proportion of Subjects in the CAPITIS Study Population With a Reinfection (All Indications). Development of non-bacteremic urinary tract infection signs or symptoms (dysuria, urinary frequency, urinary urgency, suprapubic pain or temperature greater than 38 degrees Celsius) in patients with previous clinical and microbiological cure, plus positive urine culture with different strains isolated in initial culture. Investigators will compare the risk of reinfection with each regimen. |
Daily until day 30 after the first day of administration of the study drugs. | |
Secondary | Resistant clinical isolates in patient follow-up. | Proportion of Subjects in the CAPITIS Study Population With Resistant clinical isolates. Appearance of clinical isolates of Escherichia coli or Klebsiella pneumoniae resistant piperacillin/tazobactam or carbapenems demonstrated in urine cultures will be evaluated. |
Daily until day 30 after the first day of administration of the study drugs. | |
Secondary | Adverse events in patient follow-up. | Proportion of Subjects in the CAPITIS Study Population With Adverse events (All Indications). Any related adverse event occurring from the signing the informed consent form to end of follow. Investigators have created a data collection notebook, a daily follow-up will be made in the participants and adverse events in patient will be recorded. |
Daily until day 30 after the first day of administration of the study drugs. | |
Secondary | ICU admission in patient follow-up. | Proportion of Subjects in the CAPITIS Study Population With ICU admission (All Indications). Any admission to intensive care unit occurs from signing the informed consent form to end of patient follow. Investigators have created a data collection notebook, a daily follow-up will be made in the participants and all admission in ICU will be recorded. |
Daily until day 30 after the first day of administration of the study drugs. | |
Secondary | Clinical or microbiological failure of antibiotic therapy in patient follow-up. | Proportion of Subjects in the CAPITIS Study Population With Clinical or microbiological failure of antibiotic therapy (All Indications). Failure to achieve clinical or microbiologic cure until day 30, or die at any time since signing the informed consent form to end of follow-up. Authors defined the clinical therapeutic failure as the persistence of at least one urinary symptom in the patient at the time of follow-up despite antibiotic therapy. Microbiological failure has been defined as the persistence of bacteria isolation major to 10.000 UFC/ml in second urine culture carried out in the study participant despite antibiotic therapy. Investigators have created a questionnaire which will be checked daily with a urinary symptoms list. All findings will be recorded in a data collection notebook. |
Daily until day 30 after the first day of administration of the study drugs. |
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