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Effect of Mycobacterial Infection on Immune Status (EMIIS)

4. juni 2026 opdateret af: Chao Cao, Ph.D., First Affiliated Hospital of Ningbo University
This study, titled "Effect of Mycobacterial Infection on Immune Status" (EMIIS), investigates the immune-driven mechanisms of mycobacterial infections, focusing on the dynamic immune characteristics of multidrug-resistant tuberculosis (MDR-TB), nontuberculous mycobacterial (NTM) infections, and tuberculous pleurisy. Mycobacterial infections (including the Mycobacterium tuberculosis complex and nontuberculous mycobacteria) remain a major global public health threat. EMIIS is a single-center, randomized, single-blind,prospective study. The study recruited 120 participants, divided into groups of healthy individuals/community-acquired pneumonia patients, active pulmonary tuberculosis patients, latent tuberculosis infection patients, tuberculous pleurisy patients, and nontuberculous mycobacteria patients. Blood samples were collected from all groups within 3 days before treatment and 2-3 months after treatment. Pleural effusion samples were additionally collected from the tuberculous pleurisy group within 3 days before treatment and 2 months after treatment. Exhaled breath condensate (EBC) was collected from the nontuberculous mycobacteria group. Utilizing mass cytometry (CyTOF) and multi-dimensional indicators, the study aims to elucidate the immune-driven mechanisms of mycobacterial infections and provide new strategies for individualized treatment.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Observationel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
120

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
      • Ningbo, Kina
        • Rekruttering
        • The First Affiliated Hospital of Ningbo University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients with clinical diagnosis including (active tuberculosis, latent tuberculosis, multidrug-resistant tuberculosis, tuberculous pleurisy, nontuberculous mycobacteria), older than 18 years, meeting the inclusion criteria and no exclusion criteria.

Beskrivelse

Inclusion Criteria and Exclusion Criteria:

Inclusion Criteria：

  1. Age ≥ 18 years, all genders and races accepted.
  2. Patients with active pulmonary tuberculosis diagnosed clinically or by bronchoscopy within less than 1 week.
  3. Patients with latent tuberculosis infection (positive T-SPOT test but no evidence of active tuberculosis infection).
  4. Patients with tuberculous pleurisy with onset within less than 1 week.
  5. Voluntarily join this study and sign the informed consent form.
  6. Patients whose drug susceptibility test or NGS results indicate resistance to at least isoniazid and rifampicin (MDR-TB).
  7. Patients whose drug susceptibility test or NGS results indicate sensitivity to first-line anti-tuberculosis drugs.
  8. Patients whose drug susceptibility test or NGS results indicate resistance to only one anti-tuberculosis drug.
  9. Patients with newly identified nontuberculous mycobacterial infection (within less than 1 week) by sputum culture or NGS.

Exclusion Criteria：

  1. Immunosuppressive conditions including HIV infection, long-term use (>1 month) of immunosuppressive agents or corticosteroids, severe malnutrition, etc.
  2. Concurrent other lung diseases, severe liver or kidney dysfunction, severe endocrine diseases, hematological diseases, or malignant tumors that may affect the study outcomes.
  3. Patients with diabetes mellitus.
  4. Pregnant or lactating women.
  5. Patients unable or unwilling to provide informed consent, or with poor compliance.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte

Gruppe / kohorte

En gruppe eller undergruppe af deltagere i et observationsstudie, der vurderes for biomedicinske eller sundhedsmæssige resultater.
Immunometabolic differences between DS-TB and MDR-TB
Using a prospective, single-center, observational study design, it is planned to enroll 30 patients divided into drug-susceptible tuberculosis and multidrug-resistant tuberculosis. CyTOF technology was used to analyze the differences in immune subsets and metabolic functions.
To assess the effect of immune status on NTM
A total of 15 patients over the age of 18 diagnosed with non-tuberculous mycobacteria were included, and peripheral blood samples were collected after 2 months of treatment to analyze the changes in immune status and metabolic status of non-tuberculous mycobacterial patients in healthy people.
Significance of studying the immunometabolic status of tuberculous pleurisy
A total of 20 patients over the age of 18 diagnosed with tuberculous pleurisy were included in the plan, divided into high-symptom and low-symptomatic groups, and pleural fluid and peripheral blood samples were collected before and after treatment to analyze the changes in their immune status and metabolic status before and after treatment.
Study of immunometabolic status in different states of tuberculosis
A total of 15 patients over the age of 18 diagnosed with active pulmonary tuberculosis and 10 patients with latent pulmonary tuberculosis were enrolled, and peripheral blood samples were collected before and after treatment to analyze the changes in their immune status and metabolic status before and after treatment.
A study of exhaled air condensate in NTM patients versus CAP patients
A total of 30 patients over the age of 18 diagnosed with nontuberculous mycobacteria and 30 healthy or community pneumonia patients were enrolled, and their exhaled air condensate was collected before or within 2 weeks after treatment to analyze its composition.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To establish a multi-immune pathway interaction network and composite biomarkers in mycobacterial infection thing
Tidsramme: 3 days before treatment and 2 months after treatment
This study utilized mass cytometry (CyTOF) and a pre-designed panel containing 41 metal-tagged antibodies for detection. After data normalization and doublet exclusion, multiple machine learning algorithms were applied for clustering analysis to quantitatively compare the proportions of various immune subsets (such as Th1 cells, Th17 cells, classical monocytes, CD4TEM cells, CD8TEM cells,etc.) among CD45+ leukocytes in the peripheral blood of healthy individuals and patients with active tuberculosis.
3 days before treatment and 2 months after treatment

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Immune cell subsets and mechanisms of possible effects of anti-tuberculosis drugs
Tidsramme: 3 days before treatment and 2 months after treatment
This study utilized mass cytometry (CyTOF) and a pre-designed panel containing 41 metal-tagged antibodies for detection. After data normalization and doublet exclusion, multiple machine learning algorithms were applied for clustering analysis to quantitatively compare the proportions of various immune subsets (such as Th1 cells, Th17 cells, classical monocytes, CD4TEM cells, CD8TEM cells,etc.) among CD45+ leukocytes in the peripheral blood of healthy individuals and patients with active tuberculosis.
3 days before treatment and 2 months after treatment
Differences in immune subsets between normal persons and patients with active pulmonary tuberculosis
Tidsramme: 3 days before treatment and 2 months after treatment
This study utilized mass cytometry (CyTOF) and a pre-designed panel containing 41 metal-tagged antibodies for detection. After data normalization and doublet exclusion, multiple machine learning algorithms were applied for clustering analysis to quantitatively compare the proportions of various immune subsets (such as Th1 cells, Th17 cells, classical monocytes, CD4TEM cells, CD8TEM cells,etc.) among CD45+ leukocytes in the peripheral blood of healthy individuals and patients with active tuberculosis.
3 days before treatment and 2 months after treatment
To explore whether the peripheral blood before treatment contains a certain marker can predict the short-term efficacy
Tidsramme: 3 days before treatment and 2 months after treatment
This study utilized mass cytometry (CyTOF) and a pre-designed panel containing 41 metal-tagged antibodies for detection. After data normalization and doublet exclusion, multiple machine learning algorithms were applied for clustering analysis to quantitatively compare the proportions of various immune subsets (such as Th1 cells, Th17 cells, classical monocytes, CD4TEM cells, CD8TEM cells,etc.) among CD45+ leukocytes in the peripheral blood of healthy individuals and patients with active tuberculosis.
3 days before treatment and 2 months after treatment
Comparison of the dynamic changes of immune subsets in peripheral blood and pleural effusion of TP patients before and after treatment
Tidsramme: 3 days before treatment and 2 months after treatment
Using CyTOF with a 41-metal-labeled antibody panel, peripheral blood samples from healthy controls and untreated patients with tuberculous pleurisy were analyzed. After data normalization and debarcoding, clustering was applied to determine the percentages of CD45+ leukocyte subsets (Th1, Th17, classical monocytes, CD4+/CD8+ effector memory T cells, and NK cells). Patients were divided into high- and low-symptom groups based on symptom severity. Immune subset proportions were compared between each patient group and healthy controls, as well as between the two patient groups.
3 days before treatment and 2 months after treatment
To explore the differences of peripheral blood immune subsets between TP patients and healthy people before treatment
Tidsramme: 3 days before treatment and 2 months after treatment
Using CyTOF with a 41-metal-labeled antibody panel, peripheral blood samples from healthy controls and untreated patients with tuberculous pleurisy were analyzed. After data normalization and debarcoding, clustering was applied to determine the percentages of CD45+ leukocyte subsets (Th1, Th17, classical monocytes, CD4+/CD8+ effector memory T cells, and NK cells). Patients were divided into high- and low-symptom groups based on symptom severity. Immune subset proportions were compared between each patient group and healthy controls, as well as between the two patient groups.
3 days before treatment and 2 months after treatment
To explore the metabolic differences of three major nutrients between TP patients and healthy people before treatment
Tidsramme: 3 days before treatment and 2 months after treatment
Using CyTOF with an antibody panel including metabolic markers such as GLUT1 and CPT1A, the expression levels of these markers were measured in peripheral blood immune subsets (CD4+ T cells, CD8+ T cells, monocytes, etc.) from healthy controls and untreated patients with tuberculous pleurisy. The median fluorescence intensity (MdFI) of GLUT1 and CPT1A on each subset was used as the primary metric to quantify differences in glucose metabolism and fatty acid oxidation capacity.
3 days before treatment and 2 months after treatment
Differences in metabolic function between multidrug-resistant tuberculosis group and drug-sensitive tuberculosis group
Tidsramme: 3 days before treatment and 2 months after treatment
In this study, CyTOF and a preconfigured panel consisting of 41 metal-conjugated antibodies were used for specimen detection. After data normalization and doublet removal, multiple machine learning algorithms were utilized for cell clustering analysis. We quantitatively compared the proportional differences of various immune subsets in peripheral blood CD45⁺ leukocytes among drug-resistant tuberculosis (DR-TB), drug-susceptible tuberculosis (DS-TB) and healthy control groups, including Th1 cells, Th17 cells, classical monocytes, CD4⁺ effector memory T cells and CD8⁺ effector memory T cells. This study aims to characterize treatment-induced quantitative changes in immune subsets and provide evidence for screening novel biomarkers.
3 days before treatment and 2 months after treatment
Influence of immune status on the efficacy of NTM
Tidsramme: 3 days before treatment and 2 months after treatment
This study utilized mass cytometry (CyTOF) and a pre-designed panel containing 41 metal-tagged antibodies for detection. After data normalization and doublet exclusion, multiple machine learning algorithms were applied for clustering analysis to quantitatively compare the proportions of various immune subsets (such as Th1 cells, Th17 cells, classical monocytes, CD4TEM cells, CD8TEM cells,etc.) among CD45+ leukocytes in the peripheral blood of healthy individuals and patients with active tuberculosis.
3 days before treatment and 2 months after treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
First Affiliated Hospital of Ningbo University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
9. juli 2025

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
20. juli 2026

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
20. juli 2026

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
19. maj 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
4. juni 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
4. juni 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • 2025-157A-01

Plan for individuelle deltagerdata (IPD)

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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