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Kinetics of Biomarkers in Acute Pyelonephritis

This study has been completed.
Information provided by:
University Hospital, Geneva Identifier:
First received: December 8, 2008
Last updated: October 6, 2010
Last verified: June 2010
The objective of this study is to explore the kinetics of biomarkers in 30 adult female patients with uncomplicated acute pyelonephritis.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Kinetics of Procalcitonin, C-reactive Protein and Pyuria in Uncomplicated Pyelonephritis in Women: A Pilot Study

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Blood and urine biomarkers (procalcitonin, C-reactive protein, SIGNATURE(TM) test, pyuria [ Time Frame: Daily till day 15. ]

Estimated Enrollment: 30
Study Start Date: December 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Acute uncomplicated pyelonephritis

Detailed 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
30 adult females with acute uncomplicated pyelonephritis

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00805181

Geneva University Hospitals
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Principal Investigator: Olivier T Rutschmann, MD, MPH University Hospital, Geneva
  More Information

Responsible Party: Medical Director, University Hospital, Geneva Identifier: NCT00805181     History of Changes
Other Study ID Numbers: CER08-170
Study First Received: December 8, 2008
Last Updated: October 6, 2010

Additional relevant MeSH terms:
Nephritis, Interstitial
Kidney Diseases
Urologic Diseases
Pyelitis processed this record on August 23, 2017