NocardiosisCENOCIMNCT07013006
Retrospective Study to Assess the Evolution of MRI or CT Lesions in Treated CNS Nocardiosis
An observational study of Nocardiosis, run by Assistance Publique - Hôpitaux de Paris at 13 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nocardiosis
- What is being tested?
- Collection of data from the patient's medical file
- How many people
- 64 participants
- Where
- 13 sitesFrance
- Study dates
- 25 Sep 2026to 1 Oct 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with cerebral nocardiosis and cared at an Assistance Publique -Hôpitaux de Paris hospital between 01/01/2004 and 01/12/2024.
Who may be able to join
- 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.
Who cannot join
- Refusal or impossibility of information.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Hôpital Avicenne
Bobigny, 93000
Hôpital Ambroise-Paré
Boulogne-Billancourt, 92100
Hôpital Beaujon
Clichy, 92110
Hôpital Mondor
Créteil, 94000
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Hôpital Saint-Louis- Hôpital Lariboisière
Paris, 75010
Hôpital Armand-Trousseau
Paris, 75012
Hôpital Saint-Antoine
Paris, 75012
Hôpital Pitié-Salpêtrière
Paris, 75013
Hôpital Cochin
Paris, 75014
Hôpital Européen Georges-Pompidou, HEGP
Paris, 75015
Hôpital Necker-Enfants Malades
Paris, 75015
Hôpital Bichat - Claude-Bernard
Paris, 75018
About this study
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.
Read the 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.
- Conditions
- Nocardiosis
- Being tested
- Collection of data from the patient's medical file
- Keywords
- Nocardiosis, Nocardia spp., Radiological monitoring, Cerebral involvement
- Medical subject headings
- Nocardia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of data from the patient's medical fileOther
Collection of data from the patient's medical file.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Collection of data from the patient's medical file |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
Percentage of CT brain scans suggestive of cerebral nocardiosis
Percentage of CT brain scans finding abnormalities suggestive of cerebral nocardiosis, considering MRI as the gold standard for diagnosing cerebral nocardiosis.
Measured: 12 months
Description of the variation in radiological presentation of cerebral nocardiosis lesions
Description of the variation in radiological presentation (number of abscesses, abscesses size, contrast uptake, vasculitic lesions, associated ventriculitis) according to the patient's background (transplantation, anti-GM-CSF antibodies, allogeneic CSH graft, others).
Measured: 12 months
Percentage of cerebral vasculitis lesions
Percentage of cerebral vasculitis lesions on brain MRI.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start25 Sep 2026
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NocardiosisStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Margaux MD Garzaro, Principal investigator, Assistance Publique - Hôpitaux de ParisOlivier MD, PhD Lortholary, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013006
- Sponsor's protocol ID
- APHP250649
- Acronym
- CENOCIM
- Status last verified
- Oct 2026
- First submitted
- 30 May 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34596213Lebeaux 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.
PubMed 28329348
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study to Assess the Evolution of MRI or CT Lesions in Treated CNS Nocardiosis
- ClinicalTrials.gov ID
- NCT07013006
- Acronym / sponsor ID
- CENOCIM / APHP250649
- Conditions
- Nocardiosis
- Keywords
- Nocardiosis, Nocardia spp., Radiological monitoring, Cerebral involvement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 25 Sep 2026 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 10 Jun 2025 (actual)
- 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Collection of data from the patient's medical filePatient 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with cerebral nocardiosis and cared at an Assistance Publique -Hôpitaux de Paris hospital between 01/01/2004 and 01/12/2024.
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (1 listed)
- Refusal or impossibility of information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of data from the patient's medical fileCollection of data from the patient's medical file. | Other | Patients |
Primary outcome
Percentage reduction in cerebral nocardiosis lesions
Time frame: 12 months
Percentage reduction in cerebral nocardiosis lesions in patients with a favorable evolution and those with an unfavorable evolution at 12 months from diagnosis.
3 secondary outcomes
Percentage of CT brain scans suggestive of cerebral nocardiosis
Time frame: 12 months
Description of the variation in radiological presentation of cerebral nocardiosis lesions
Time frame: 12 months
Percentage of cerebral vasculitis lesions
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 34596213Averbuch 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.
- Background: PubMed 28329348Lebeaux 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.
- Individual participant dataSharing planned: No
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.
Margaux MD Garzaro principal investigator
Assistance Publique - Hôpitaux de Paris
Olivier MD, PhD Lortholary study director
Assistance Publique - Hôpitaux de Paris
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nocardiosis, run by Assistance Publique - Hôpitaux de Paris at 13 sites 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 1 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: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage reduction in cerebral nocardiosis lesions (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07013006, which also lists 2 linked publications.
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 27 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.