Contrast-Enhanced US of Spleen, Liver and Kidney

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2005 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190281
First received: September 13, 2005
Last updated: December 12, 2005
Last verified: March 2005
  Purpose

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 Phase
Malaria
Pyelonephritis
Bacterial Infections
Phase 3

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Contrast-Enhanced US of Spleen, Liver and Kidney in Patients With Acute Infection (Malaria and Other Infectious Diseases: a Functional Study

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Estimated Enrollment: 53
Study Start Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00190281     History of Changes
Other Study ID Numbers: 04 025
Study First Received: September 13, 2005
Last Updated: December 12, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on April 17, 2014