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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
History of Changes

September 13, 2005
December 12, 2005
August 2005
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Complete list of historical versions of study NCT00190281 on ClinicalTrials.gov Archive Site
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Contrast-Enhanced US of Spleen, Liver and Kidney
Contrast-Enhanced US of Spleen, Liver and Kidney in Patients With Acute Infection (Malaria and Other Infectious Diseases: a Functional Study

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.

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.
Observational
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
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  • Malaria
  • Pyelonephritis
  • Bacterial Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
53
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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
Both
18 Years and older
No
Contact: Olivier Lortholary, MD PhD 33-1-44-49-41-42 olivier.lortholary@nck.ap-hop-paris.fr
France
 
NCT00190281
04 025
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Assistance Publique - Hôpitaux de Paris
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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
Assistance Publique - Hôpitaux de Paris
March 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP