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
  Purpose

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


Condition
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. ] [ Designated as safety issue: No ]

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)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

30 adult females with acute uncomplicated pyelonephritis

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805181

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

No publications provided

Responsible Party: Medical Director, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00805181     History of Changes
Other Study ID Numbers: CER08-170, PRD-08-I-4
Study First Received: December 8, 2008
Last Updated: October 6, 2010
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Pyelonephritis
Nephritis, Interstitial
Nephritis
Kidney Diseases
Urologic Diseases
Pyelitis

ClinicalTrials.gov processed this record on April 15, 2014