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

History of Changes

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

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 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 Kidney Diseases Nephritis	Nephritis, Interstitial Pyelitis Urologic Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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