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
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, see Learn About Clinical Studies.

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 July 29, 2014