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Clinical Trials/NCT07607288
NCT07607288Enrolling By InvitationNot Applicable

Clinical Study on the Correlation Between Plasma Concentrations of Antituberculosis Drugs and Treatment Efficacy/Safety.

Beijing Chest Hospital1 site in 1 country2,215 target enrollmentStarted: January 1, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
2,215
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this clinical trial is to investigate the correlation between anti-tuberculosis drug concentration monitoring and treatment efficacy and safety through analytical studies.The main questions it aims to answer include:

Guidance for individualized dosage adjustment of anti-tuberculosis drugs; Guidance on medication challenges for special populations and patients with comorbidities;Address the dose optimization issue for refractory tuberculosis.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
5 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with tuberculosis confirmed by bacteriological or pathological diagnosis;
  • •Those who have received standardized anti-tuberculosis treatment regimens;
  • •Patients with complete clinical records and completed follow-up for at least one treatment course.

Exclusion Criteria

  • •Baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels>2 times the upper limit of normal;
  • •Concurrent chronic liver diseases such as chronic hepatitis B, hepatitis C, or alcoholic liver disease;
  • •Concurrent severe underlying cardiac conditions (e.g.,congenital heart disease, cardiomyopathy, severe arrhythmias);
  • •Concurrent use of multiple medications that may affect cardiac function;
  • •Human immunodeficiency virus (HIV) co-infection;
  • •Women who are pregnant or breastfeeding.

Investigators

Sponsor
Beijing Chest Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nie WenJuan

chief physician

Beijing Chest Hospital

Study Sites (1)

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