Clinical trial NCT07013006: Retrospective Study to Assess the Evolution of MRI or CT Lesions in Treated CNS Nocardiosis
Official title: Retrospective Study to Assess the Evolution of MRI or CT Lesions in Treated CNS Nocardiosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Nocardiosis
Keywords: Nocardiosis
Nocardia spp.
Radiological monitoring
Cerebral involvement
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with cerebral nocardiosis and cared at an Assistance Publique -Hôpitaux de Paris hospital between 01/01/2004 and 01/12/2024.

Brief summary: Nocardiosis is a rare infection caused by bacteria of the genus Nocardia spp. It primarily affects immunocompromised individuals, such as solid organ or hematopoietic stem cell transplant recipients, as well as individuals with anti-GM-CSF antibodies. The infection typically begins by inhalation, affecting the lungs, with frequent hematogenous spread to the brain and soft tissues. Cerebral involvement is present in 20 to 40% of cases, although 40% of patients remain neurologically asymptomatic.

Treatment consists of prolonged antibiotic therapy and, sometimes, surgical drainage for large or refractory abscesses. Mortality associated with cerebral involvement varies between 20 and 40%. Although radiological improvements are observed under treatment, the link between image changes and clinical prognosis remains uncertain. Regular radiological monitoring is recommended during and after treatment, although the expected evolution has not been described in the literature.

Detailed description: Nocardiosis is a rare infection caused by bacteria of the genus Nocardia spp. It primarily affects immunocompromised individuals, such as solid organ or hematopoietic stem cell transplant recipients, as well as individuals with anti-GM-CSF antibodies. The infection typically begins by inhalation, affecting the lungs, with frequent hematogenous spread to the brain and soft tissues. Cerebral involvement is present in 20 to 40% of cases, although 40% of patients remain neurologically asymptomatic. Brain imaging is essential for diagnosis, with MRI often being preferred due to its sensitivity. Images often show multiple abscesses, but without sufficient specificity to differentiate nocardiosis from other pathogens. New MRI techniques could improve lesion characterization.

Treatment consists of prolonged antibiotic therapy and, sometimes, surgical drainage for large or refractory abscesses. Mortality associated with cerebral involvement varies between 20 and 40%. Although radiological improvements are observed under treatment, the link between image changes and clinical prognosis remains uncertain. Regular radiological monitoring is recommended during and after treatment, although the expected evolution has not been described in the literature.

Eligibility criteria: Inclusion Criteria:

* Minor or adult patient with cerebral nocardiosis, defined by the presence of compatible clinical and radiological signs associated with the detection of Nocardia spp. in a biological sample (cerebral or extracerebral).
* With available imaging tests:

  * All patients with 3 brain imaging tests at the 3 stages of treatment: within 2 weeks of diagnosis, upon transition to maintenance treatment (3-6 weeks after the start of treatment), and at the end of treatment (between 1 month before and 1 month after the end of antibiotic treatment). MRI scans are preferred; in the absence of MRI images, contrast-enhanced CT scans will be included.
  * OR: any patient who has undergone an MRI and a contrast-enhanced CT scan within two weeks of diagnosis, with the two tests performed within 72 hours of each other.
  * OR: any patient with a multimodal brain MRI at any time during infection, preferably within one month of diagnosis.

Exclusion Criteria:

* Refusal or impossibility of information.

Primary outcomes:
measure: Percentage reduction in cerebral nocardiosis lesions
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of CT brain scans suggestive of cerebral nocardiosis
timeFrame: 12 months
measure: Description of the variation in radiological presentation of cerebral nocardiosis lesions
timeFrame: 12 months
measure: Percentage of cerebral vasculitis lesions
timeFrame: 12 months
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise-Paré
city: Clichy
country: France
facility: Hôpital Beaujon
city: Créteil
country: France
facility: Hôpital Mondor
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
city: Paris
country: France
facility: Hôpital Saint-Louis- Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Armand-Trousseau
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Européen Georges-Pompidou, HEGP
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
city: Paris
country: France
facility: Hôpital Bichat - Claude-Bernard
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Margaux MD Garzaro
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Olivier MD, PhD Lortholary
role: STUDY_DIRECTOR
References:
citation: Averbuch D, De Greef J, Dureault A, Wendel L, Tridello G, Lebeaux D, Mikulska M, Gil L, Knelange N, Zuckerman T, Roussel X, Robin C, Xhaard A, Aljurf M, Beguin Y, Le Bourgeois A, Botella-Garcia C, Khanna N, Van Praet J, Kroger N, Blijlevens N, Ducastelle Lepretre S, Ho A, Roos-Weil D, Yeshurun M, Lortholary O, Fontanet A, de la Camara R, Coussement J, Maertens J, Styczynski J; European Study Group for Nocardia in Hematopoietic Cell Transplantation. Nocardia Infections in Hematopoietic Cell Transplant Recipients: A Multicenter International Retrospective Study of the Infectious Diseases Working Party of the European Society for Blood and Marrow Transplantation. Clin Infect Dis. 2022 Aug 24;75(1):88-97. doi: 10.1093/cid/ciab866.
citation: Lebeaux D, Freund R, van Delden C, Guillot H, Marbus SD, Matignon M, Van Wijngaerden E, Douvry B, De Greef J, Vuotto F, Tricot L, Fernandez-Ruiz M, Dantal J, Hirzel C, Jais JP, Rodriguez-Nava V, Jacobs F, Lortholary O, Coussement J; European Study Group for Nocardia in Solid Organ Transplantation; European Study Group for Nocardia in Solid Organ Transplantation. Outcome and Treatment of Nocardiosis After Solid Organ Transplantation: New Insights From a European Study. Clin Infect Dis. 2017 May 15;64(10):1396-1405. doi: 10.1093/cid/cix124.