Contrast-Enhanced US of Spleen, Liver and Kidney

Malaria Clinical Trial

Official title:

Contrast-Enhanced US of Spleen, Liver and Kidney in Patients With Acute Infection (Malaria and Other Infectious Diseases: a Functional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00190281
• Other study ID #: 04 025
• Status: Recruiting
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: December 12, 2005
• Start date: August 2005

Study information

• Verified date: March 2005
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Olivier Lortholary, MD PhD
• Phone: 33-1-44-49-41-42
• Email: olivier.lortholary[@]nck.ap-hop-paris.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Bacterial Infections
• Malaria
• Pyelonephritis

Locations

Country	Name	City	State
France	Department of Adult Radiology, Necker University Hospital	Paris	Ile de france

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France,