Contrast-Enhanced US of Spleen, Liver and Kidney

NCT ID: NCT00190281

Last Updated: 2005-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malaria Pyelonephritis Bacterial Infections

Keywords

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FUNCTIONAL STUDY CONTRAST-ENHANCED US PERFUSION

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Principal Investigators

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Jean-Michel Correas, MD PhD

Role: PRINCIPAL_INVESTIGATOR

NECKER UNIVERSITY HOSPITAL

Pierre Buffet, MD PhD

Role: STUDY_DIRECTOR

Centre Médical - Institut Pasteur

Olivier Lortholary, MD PhD

Role: STUDY_DIRECTOR

NECKER UNIVERSITY HOSPITAL

Locations

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Department of Adult Radiology, Necker University Hospital

Paris, Île-de-France Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Olivier Lortholary, MD PhD

Role: CONTACT

Phone: 33-1-44-49-41-42

Email: [email protected]

Facility Contacts

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Jean-Michel Correas, MD PhD

Role: primary

Other Identifiers

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04 025

Identifier Type: -

Identifier Source: org_study_id