MalariaNCT00190281
Contrast-Enhanced US of Spleen, Liver and Kidney
An observational study of Malaria and Pyelonephritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malaria, Pyelonephritis, Bacterial Infections
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2005to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Social security number
- Age over 18
- acute malaria infection or other infectious diseases
- Inpatients
- Signed informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Department of Adult Radiology, Necker University Hospital
Paris, Île-de-France Region, 75015
Jean-Michel Correas, MD PhD, 33-1 44 49 41 40, jean-michel;correas@nck.aphp.fr
Jean-Michel Correas, MD PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Malaria, Pyelonephritis, Bacterial Infections
- Keywords
- FUNCTIONAL STUDY, CONTRAST-ENHANCED US, PERFUSION
- Medical subject headings
- Malaria, Pyelonephritis, Bacterial Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 53 participants
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Michel Correas, MD PhD, Principal investigator, Hôpital Necker-Enfants MaladesPierre Buffet, MD PhD, Study director, Centre Médical - Institut PasteurOlivier Lortholary, MD PhD, Study director, Hôpital Necker-Enfants Malades
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190281
- Sponsor's protocol ID
- 04 025
- Status last verified
- Mar 2005
- First submitted
- 13 Sep 2005
- Last updated
- 13 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-Enhanced US of Spleen, Liver and Kidney in Patients With Acute Infection (Malaria and Other Infectious Diseases: a Functional Study
- ClinicalTrials.gov ID
- NCT00190281
- Acronym / sponsor ID
- 04 025
- Conditions
- Malaria, Pyelonephritis, Bacterial Infections
- Keywords
- FUNCTIONAL STUDY, CONTRAST-ENHANCED US, PERFUSION
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 53 participants
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Aug 2005
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Social security number
- Age over 18
- acute malaria infection or other infectious diseases
- Inpatients
- Signed informed consent form
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel Correas, MD PhD principal investigator
Hôpital Necker-Enfants Malades
Pierre Buffet, MD PhD study director
Centre Médical - Institut Pasteur
Olivier Lortholary, MD PhD study director
Hôpital Necker-Enfants Malades
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria and Pyelonephritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier Lortholary, MD PhD (33-1-44-49-41-42, olivier.lortholary@nck.ap-hop-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2005.