Kinetics of Biomarkers in Acute Pyelonephritis

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00805181
First received: December 8, 2008
Last updated: October 6, 2010
Last verified: June 2010

December 8, 2008
October 6, 2010
December 2008
April 2010   (final data collection date for primary outcome measure)
Blood and urine biomarkers (procalcitonin, C-reactive protein, SIGNATURE(TM) test, pyuria [ Time Frame: Daily till day 15. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00805181 on ClinicalTrials.gov Archive Site
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Kinetics of Biomarkers in Acute Pyelonephritis
Kinetics of Procalcitonin, C-reactive Protein and Pyuria in Uncomplicated Pyelonephritis in Women: A Pilot Study

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

30 adult females with acute uncomplicated pyelonephritis

Pyelonephritis
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Acute uncomplicated pyelonephritis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00805181
CER08-170, PRD-08-I-4
No
Medical Director, University Hospital, Geneva
University Hospital, Geneva
Not Provided
Principal Investigator: Olivier T Rutschmann, MD, MPH University Hospital, Geneva
University Hospital, Geneva
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP