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Clinical Study of New Intensive Treatment Regimen for Severe Nontuberculous Mycobacterial Pulmonary Disease

NCT05494957 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-08-10

No results posted yet for this study

Summary

Investigators have selected a number of new drugs, including bedaquiline, to form a regimen to conduct clinical studies for the treatment of severe NTM lung disease.

Conditions

  • Nontuberculous Mycobacterial Lung Disease

Interventions

DRUG

New regimen(BdqCfzLzd+XY)

The basic regimen consists of bedaquiline, clofazimine, linezolid, and 2-3 drugs such as amikacin and tigecycline are selected according to the drug use history and in vitro culture drug sensitivity results to form the regimen, and the treatment period is usually more than 12 months, and the doses of various drugs are used for the regular drug use.

Sponsors & Collaborators

  • Shanghai Public Health Clinical Center

    collaborator OTHER_GOV

  • No.85 Hospital, Changning, Shanghai, China

    collaborator OTHER

  • Anhui Chest Hospital

    collaborator OTHER

  • Shanghai Pudong New Area Pulmonary Hospital, China

    collaborator UNKNOWN

  • Huashan Hospital

    collaborator OTHER

  • Zhengzhou Sixth People's Hospital, China

    collaborator UNKNOWN

  • Shanghai Pulmonary Hospital, Shanghai, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-05
Primary Completion
2024-08-05
Completion
2025-08-05

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05494957 on ClinicalTrials.gov