NCT00805181

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

October 7, 2010

Status Verified

June 1, 2010

Enrollment Period

1.3 years

First QC Date

December 8, 2008

Last Update Submit

October 6, 2010

Conditions

Pyelonephritis

Outcome Measures

Primary Outcomes (1)

  • Blood and urine biomarkers (procalcitonin, C-reactive protein, SIGNATURE(TM) test, pyuria

    Daily till day 15.

Study Arms (1)

Acute uncomplicated pyelonephritis

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30 adult females with acute uncomplicated pyelonephritis

You may qualify if:

  • \> 18 years
  • Flank/loin pain or tenderness, or both and fever \> 38°C during the last 48 hours and pyuria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospitals

Geneva, Canton of Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Pyelonephritis

Condition Hierarchy (Ancestors)

Nephritis, InterstitialNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPyelitisMale Urogenital Diseases

Study Officials

  • Olivier T Rutschmann, MD, MPH

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 8, 2008

First Posted

December 9, 2008

Study Start

December 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

October 7, 2010

Record last verified: 2010-06

Locations

CH(1)