- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00805181
Kinetics of Biomarkers in Acute Pyelonephritis
October 6, 2010 updated by: University Hospital, Geneva
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Geneva, Switzerland, 1211
- Geneva University Hospitals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
30 adult females with acute uncomplicated pyelonephritis
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Acute uncomplicated pyelonephritis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood and urine biomarkers (procalcitonin, C-reactive protein, SIGNATURE(TM) test, pyuria
Time Frame: Daily till day 15.
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Daily till day 15.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
December 8, 2008
First Submitted That Met QC Criteria
December 8, 2008
First Posted (Estimate)
December 9, 2008
Study Record Updates
Last Update Posted (Estimate)
October 7, 2010
Last Update Submitted That Met QC Criteria
October 6, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CER08-170
- PRD-08-I-4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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