- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01138566
Clinical Significance and Optimal Treatment of Community-onset Urinary Tract Infections Caused by Extended-spectrum β-lactamase and/or AmpC β-lactamase Producing Enterobacteriaceae
The purposes of this study are:
- To estimate the prevalence of extended spectrum β-lactamase (ESBL) and/or AmpC among Enterobacteriaceae which cause community-onset urinary tract infections (UTIs)
- To collect the background, risk factors and clinical outcome of patients with community-acquired uropathogenic condition related to Enterobacteriaceae (both ESBL, AmpC- and non ESBL and/or AmpC producing) after receive different antibiotic regimens.
- To develop a scoring system to early identify patients at risk of being infected with ESBL- and/or AmpC-producing Enterobacteriaceae by comparing the risk factors for community-onset UTIs caused by ESBL- and/or AmpC-positive against non ESBL -and/or AmpC Enterobacteriaceae
- To demonstrate the efficacy and safety of ertapenem for the empiric treatment of community-onset UTIs in patients at risk for ESBL- and/or AmpC-producing organism.
The study hypothesis (i) Patients infected with community-acquired uropathogenic ESBL- and/or AmpC-producing Enterobacteriaceae who receive regimens other than carbapenems have a worse outcome.
(ii) There are certain risk factors predicting the acquisition of community-onset UTIs caused by ESBL- and/or AmpC-producing Enterobacteriaceae.
(iii) The use of ertapenem is an effective and safe empirical therapy compared with other agents for community-onset UTIs caused by ESBL- and/or AmpC-producing Enterobacteriaceae.
Studieoversikt
Status
Forhold
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Chang-Phone Fung, M.D.
- Telefonnummer: +886-2-2875-7494
- E-post: cpfung@vghtpe.gov.tw
Studiesteder
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Taipei, Taiwan, 11217
- Taipei Vterans General Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Adult patients who admitted to the Taipei Veterans General Hospital with the diagnosis of community-onset UTI caused by Enterobacteriaceae will be eligible for inclusion in this study if hospitalization for parental antimicrobial therapy is required
Exclusion Criteria:
- pregnancy or lactation in women,
- history of serious allergy or intolerance to study drug therapy (patients with a history of mild rash to β-lactams could be enrolled),
- complete obstruction of the urinary tract,
- peri-nephritic or intrarenal abscess, prostatitis, any rapidly progressive disease or terminal illness,
- immuno-compromising illness or immuno suppression therapy, the need for concomitant antimicrobials in addition to study therapy,
- a baseline pathogen resistant to study drug,
- treatment with a systemic antimicrobial agent for >24 h within 72 h prior to enrolment, or absolute neutrophil count <1000/mm3.
- Men with a history or physical findings suggestive of acute or chronic prostatitis will also excluded.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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ESBL- and/or AmpC-(+) or (-)
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IISP37925
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