Kinetics of Biomarkers in Acute Pyelonephritis

Pyelonephritis Clinical Trial

Official title:

Kinetics of Procalcitonin, C-reactive Protein and Pyuria in Uncomplicated Pyelonephritis in Women: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805181
• Other study ID #: CER08-170
• Secondary ID: PRD-08-I-4
• Status: Completed
• Phase: N/A
• First received: December 8, 2008
• Last updated: October 6, 2010
• Start date: December 2008
• Est. completion date: April 2010

Study information

• Verified date: June 2010
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

The objective of this study is to explore the kinetics of biomarkers in 30 adult female patients with uncomplicated acute pyelonephritis.

Description:

We will measure c-reactive protein, procalcitonin, pyuria and a new blood biomarker (Signature TM) everyday till normalization of these markers in 30 adult female patients with uncomplicated acute pyelonephritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > 18 years

• Flank/loin pain or tenderness, or both and fever > 38°C during the last 48 hours and pyuria

Exclusion Criteria:

• Pregnancy

• Presence of indwelling catheters

• Known polycystic kidney disease or any malformation of the urinary tract, or single kidney; renal transplant recipients; acute or chronic renal failure requiring dialysis

• Recent discharge from hospital (during the last 10 days); ongoing antibiotic treatment

• Known severe immunosuppression: Receiver of solid-organ or hematopoietic stem cells transplants; neutropenia ( < 1 G neutrophils / L); chronic (more than 14 days) use of systemic glucocorticoids (>10 mg/d of prednisone); active use of immunosuppressive therapy for the treatment of auto-immune or inflammatory disease; HIV infection with < 350 CD4+ cells / ml or unknown CD4+ status

• Pyelonephritis initially identified as complicated: obstruction of urinary tract, urinary stone; history of renal infection in the last 15 days

• Patient with severe sepsis or septic shock

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pyelonephritis

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood and urine biomarkers (procalcitonin, C-reactive protein, SIGNATURE(TM) test, pyuria		Daily till day 15.	No