Kinetics of Biomarkers in Acute Pyelonephritis
This study has been completed.
Sponsor:
University Hospital, Geneva
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00805181
First received: December 8, 2008
Last updated: October 6, 2010
Last verified: June 2010
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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 May 16, 2013