Retrospective Study to Assess the Evolution of MRI or CT Lesions in Treated CNS Nocardiosis

NCT07013006 | Not Yet Recruiting

• 1 other identifier: APHP250649
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 14

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.

Conditions

Nocardiosis

Keywords

Nocardiosis; Nocardia spp.; Radiological monitoring; Cerebral involvement

Outcome Measures

Primary Outcomes (1)

• Percentage reduction in cerebral nocardiosis lesions

  Percentage reduction in cerebral nocardiosis lesions in patients with a favorable evolution and those with an unfavorable evolution at 12 months from diagnosis.

  12 months

Secondary Outcomes (3)

• Percentage of CT brain scans suggestive of cerebral nocardiosis

  12 months

• Description of the variation in radiological presentation of cerebral nocardiosis lesions

  12 months

• Percentage of cerebral vasculitis lesions

  12 months

Study Arms (1)

Patients

Patient suffering from 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 extra-cerebral) between 01/01/2004 and 01/12/2024 with data collection that may continue 12 months after the end of treatment.

Other: Collection of data from the patient's medical file

Interventions

Collection of data from the patient's medical file OTHER

Collection of data from the patient's medical file.

Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Refusal or impossibility of information.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (14)

Hôpital Avicenne

Bobigny, 93000, France

Location

Hôpital Ambroise-Paré

Boulogne-Billancourt, 92100, France

Location

Hôpital Beaujon

Clichy, 92110, France

Location

Hôpital Mondor

Créteil, 94000, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Hôpital Saint-Louis- Hôpital Lariboisière

Paris, 75010, France

Location

Hôpital Armand-Trousseau

Paris, 75012, France

Location

Hôpital Saint-Antoine

Paris, 75012, France

Location

Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital Européen Georges-Pompidou, HEGP

Paris, 75015, France

Location

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Hôpital Bichat - Claude-Bernard

Paris, 75018, France

Location

Related Publications (2)

• 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.

  PMID: 34596213 BACKGROUND

• 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.

  PMID: 28329348 BACKGROUND

MeSH Terms

Conditions

Nocardia Infections

Condition Hierarchy (Ancestors)

Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Margaux MD Garzaro

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Olivier MD, PhD Lortholary

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Margaux MD Garzaro

CONTACT

0144494017; margaux.garzaro@aphp.fr

Hélène Morel

CONTACT

0171196346; helene.morel@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 10, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (14)