We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Contrast-Enhanced US of Spleen, Liver and Kidney

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00190281
Recruitment Status : Unknown
Verified March 2005 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : September 19, 2005
Last Update Posted : December 13, 2005
Sponsor:
Information provided by:

Study Description
Brief Summary:

To evaluate the changes in the microcirculation of the liver, kidney and spleen during acute infection in patients with malaria (cohorts 1 and 3) and other infectious diseases such as acute pyelonephritis at day 0 (within 8 hours of the treatment start), day 2 to 4 and day 28-32, using functional US with continuous infusion of a contrast agent (SonoVue, Bracco, Italy).

Study hypothesis: malaria patients should exhibit a different pattern of enhancement, particularly when quantitative measurements of the SU signals is performed with destruction reperfusion kinetics.


Condition or disease Phase
Malaria Pyelonephritis Bacterial Infections Phase 3

Detailed Description:

To evaluate the changes in the microcirculation of the liver, kidney and spleen during acute infection in patients with malaria (cohorts 1 and 3) and other infectious diseases such as acute pyelonephritis at day 0 (within 8 hours of the treatment start), day 2 to 4 and day 28-32, using functional US with continuous infusion of a contrast agent (SonoVue, Bracco, Italy).

Three cohortes will be studied: cohorte 1 infection at Plasmodium falciparum (24 patients), cohorte 3 infection at Plasmodium vivax, ovale or malariae (5 patients) and cohorte 2 other infectious diseases such as acute pyelonephritis (24 patients).

Study hypothesis: malaria patients should exhibit a different pattern of enhancement, particularly when quantitative measurements of the SU signals is performed with destruction reperfusion kinetics.


Study Design

Study Type : Observational
Estimated Enrollment : 53 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Contrast-Enhanced US of Spleen, Liver and Kidney in Patients With Acute Infection (Malaria and Other Infectious Diseases: a Functional Study
Study Start Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Social security number
  • Age over 18
  • acute malaria infection or other infectious diseases
  • Inpatients
  • Signed informed consent form

Exclusion Criteria:

  • Pregnancy
  • Criteria of bad tolerance of infection
  • Treatment started for more than 8 hours
  • Lack of cooperation
  • History of splenectomy, hematological disease, cirrhosis with portal hypertension, splenomegaly
  • Medical treatment with beta blocker, diuretic, immunodepression drugs
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190281


Contacts
Contact: Olivier Lortholary, MD PhD 33-1-44-49-41-42 olivier.lortholary@nck.ap-hop-paris.fr

Locations
France
Department of Adult Radiology, Necker University Hospital Recruiting
Paris, Ile de france, France, 75015
Contact: Jean-Michel Correas, MD PhD    33-1 44 49 41 40    jean-michel;correas@nck.aphp.fr   
Principal Investigator: Jean-Michel Correas, MD PhD         
Sub-Investigator: Dominique Joly, MD PhD         
Sub-Investigator: Olivier Lortholary, MD PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean-Michel Correas, MD PhD Necker University Hospital
Study Director: Pierre Buffet, MD PhD Centre Médical – Institut Pasteur
Study Director: Olivier Lortholary, MD PhD Necker University Hospital
More Information

ClinicalTrials.gov Identifier: NCT00190281     History of Changes
Other Study ID Numbers: 04 025
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: December 13, 2005
Last Verified: March 2005

Keywords provided by Assistance Publique - Hôpitaux de Paris:
FUNCTIONAL STUDY
CONTRAST-ENHANCED US
PERFUSION

Additional relevant MeSH terms:
Infection
Malaria
Bacterial Infections
Pyelonephritis
Protozoan Infections
Parasitic Diseases
Nephritis, Interstitial
Nephritis
Kidney Diseases
Urologic Diseases
Pyelitis