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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01916057
Other study ID # P120115
Secondary ID AOM12047
Status Completed
Phase N/A
First received
Last updated
Start date November 19, 2013
Est. completion date February 28, 2018

Study information

Verified date April 2018
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether F18 fluorodeoxyglucose (18F-FDG) positron-emission tomography scan (PET scan) is useful for the therapy strategy of hepatosplenic candidiasis.


Description:

Chronic disseminated candidiasis, often referred to as hepatosplenic candidiasis (HSC), is an infection due to Candida spp. that mainly involves the liver and spleen. HSC occurs mostly in patients with profound and prolonged neutropenia, which is more often seen in patients with hematologic malignancies. Despite an appropriate antifungal prophylaxis, the incidence of HSC in France might be closed to 5% in patients suffering from acute leukemia. Early and adequate diagnosis and treatment of HSC are crucial, as treatment delays can negatively affect the prognosis of the underlying condition. Current guidelines recommend a 6-month duration treatment. Prolonged treatments up to 6 months are frequent, leading to antifungal toxicity and cost increase. Preliminary study by our team has already assessed F18 fluorodeoxyglucose (18F-FDG) positron-emission tomography scan (PET scan) as a diagnostic tool for HSC. 18F-FDG PET scan could be helpful in the diagnosis, follow-up and therapy strategy of HSC, helping to stop antifungal treatment. Other molecular, immunological and serological tools have to be developed in order to avoid hepatic biopsies. Actually, mycological evidence of infection is found in only 20% of the cases. The pathogenesis of HSC is also not well understood, but it is believed that it may be due to an unbalanced adaptive immune response that leads to an exacerbated inflammatory reaction, resulting in an Immune Reconstitution Inflammatory Syndrome (IRIS). In that context, a better understanding of the disease pathophysiology and of the potential genetic susceptibility could have an impact on therapy strategy. For example, new approaches such as the use of adjuvant high-dose corticosteroids have been shown beneficial. This study is the first step to improve HSC diagnosis and therapy strategy.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date February 28, 2018
Est. primary completion date June 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Patients' inclusion criteria:

- Adults aged =18 years-old

- Hospitalized for hematological malignancy or hematopoietic stem cell transplantation

- Recent (>2months), prolonged (>10 days), profound (>100 PMN/mm3), feverish neutropenia

- Suspected hepatosplenic candidiasis (typical small nodular lesions on abdominal RMI or CT)

Patients' exclusion criteria:

- hepatosplenic lesions of other proven origin

Patients' non-inclusion criteria:

- Life expectancy >3 months

- Pregnancy

- HIV infection

- Hepatic biopsy within 3 weeks before 18F-FDG PET scan

Study Design


Intervention

Device:
18F-FDG PET Scan
to determine whether F18 fluorodeoxyglucose (18F-FDG) positron-emission tomography scan (PET scan) is useful for the therapy strategy of hepatosplenic candidiasis.

Locations

Country Name City State
France Service des Maladies Infectieuses et Tropicales - Centre d'Infectiologie Necker-Pasteur, IHU Imagine - Hôpital Necker-Enfants Malades, Paris

Sponsors (5)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Institut National de la Santé Et de la Recherche Médicale, France, Institut Pasteur, University Hospital, Lille, University of Lausanne Hospitals

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Global response to therapy Clinical assessment (no fever) and PET scan assessment (intensity of liver and/or spleen lesions) at month 3
Secondary 18F-FDG PET scan and RMI usefulness in initial diagnosis Comparison between Day 0 and Month 3 exams at month 3
Secondary Serological and molecular mycological tools assessment Measurement of beta-1,3-D-glucans, mannan/anti-mannan, anti-Saccharomyces cerevisiae antibodies in comparison with controls.
Assessment of a new real-time PCR on serum and hepatic tissue
at day 0
Secondary Serological and molecular mycological tools assessment Measurement of beta-1,3-D-glucans, mannan/anti-mannan, anti-Saccharomyces cerevisiae antibodies in comparison with controls.
Assessment of a new real-time PCR on serum and hepatic tissue
at Month 3
Secondary Serological and molecular mycological tools assessment Measurement of beta-1,3-D-glucans, mannan/anti-mannan, anti-Saccharomyces cerevisiae antibodies in comparison with controls.
Assessment of a new real-time PCR on serum and hepatic tissue
at Month 6
Secondary Inflammatory cells and mediators Measurement of cytokines and lymphocytes populations on serum and hepatic tissue in comparison with controls at day 0
Secondary Inflammatory cells and mediators Measurement of cytokines and lymphocytes populations on serum and hepatic tissue in comparison with controls at month 3
Secondary Inflammatory cells and mediators Measurement of cytokines and lymphocytes populations on serum and hepatic tissue in comparison with controls at month 6
Secondary Genetic susceptibility Search for susceptibility genes to candidiasis in comparison with controls at day 0
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