- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01137929
Bacterial and Host Genetic Risk Factors in Acute Pyelonephritis
Bacterial and Host Genetic Risk Factors That Predispose Children to Acute Pyelonephritis and Renal Scarring
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Infants admitted to the inpatient ward at Children's National Medical Center for the treatment of a febrile urinary tract infection (see definitions) will be screened for inclusion into the research protocol.
UTIF: A UTIF will require the presence of
- (1) fever and/or symptoms consistent with UTI,
- (2) pyuria based on urinalysis, and
- (3) culture-proven infection with a single organism. Specifically, the study definition of UTIF will require:
- Fever: A documented temperature of at least 100.4 °F or 38°C, measured anywhere on the body either at home or at doctor's office.
Positive dipstick analysis: Pyuria on urinalysis (>10 WBC/mm3 (uncentrifuged specimen) OR >5 WBC/hpf (centrifuged specimen), OR >1+ leukocyte esterase on dipstick).
- Culture documentation of UTI: Evidence of bacteria (>5 x 104 CFU/mL (catheterized or suprapubic aspiration urine specimen). Bag collected specimens will not be acceptable
Exclusion Criteria:
- Infants who do not conform to the above inclusion criteria and who have co-morbidities such as duplication abnormalities, diabetes mellitus, over weight status, anatomical defects of the urinary tract and neuropathic bladder dysfunction.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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With APN, With VUR, With Renal Scar
This group of children who present with a febrile UTI will be found to have APN on DMSA renal scan and will also have VUR by VCUG and a renal scar on follow-up DMSA renal scan.
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With APN, With VUR, Without Renal Scar
This group of children who present with a febrile UTI will be found to have APN on DMSA renal scan and will also have VUR by VCUG and NO renal scar on follow-up DMSA renal scan.
|
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With APN, without VUR, with Renal Scar
This group of children who present with a febrile UTI will be found to have APN on DMSA renal scan but who will NOT have VUR by VCUG; however they will have a renal scar on follow-up DMSA renal scan.
|
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With APN, Without VUR, Without Renal Scar
This group of children who present with a febrile UTI will be found to have APN on DMSA renal scan and will NOT have VUR by VCUG, NOR will they have a renal scar on follow-up DMSA renal scan.
|
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Without APN, With VUR
This group of children who present with a febrile UTI will be found NOT to have APN on DMSA renal scan and will also have VUR by VCUG.
They will not undergo a second DMSA scan since the first one is normal.
|
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Without APN, Without VUR
This group of children who present with a febrile UTI will be found NOT to have APN on DMSA renal scan and will also NOT have VUR by VCUG, NOR a renal scar on follow-up DMSA renal scan.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of acute pyelonephritis lesions
Tidsramme: < 72 hours after presentation with fever and positive urine culture
|
Children under two years of age will undergo a 99m-Tc-DMSA renal scan for the detection of acute pyelonephritis lesions within 72 hours of presentation to the ED for evaluation of a fever and positive urine culture. Based on finding the characteristic lesions (such as preservation of the renal contour but with diminished photopenia. This outcome measure will be aggregated with other bacterial and host related risk factors in order to identify the salient ones that result in morbidity from bladder infection. |
< 72 hours after presentation with fever and positive urine culture
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of renal cortical scarring
Tidsramme: At least 6 months
|
Since the lesions associated with acute pyelonephritis can resolve up to 6 months following infection, we will stress the importance of obtaining these delayed scans for the purpose of ascertaining whether the inflammation has resulted in a fixed lesion, termed a renal scar.
|
At least 6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Genes-APN
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