Improving the Outcomes of Children With Tuberculosis Through Innovative Diagnostics and Treatment Monitoring

NCT06815588 | Recruiting

• 1 other identifier: EESS - RoGer Pedi
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at identifying and evaluating novel diagnostic methods for children evaluated for respiratory tuberculosis. The investigators will use alternative samples like stool, urine, and masks to diagnose children with respiratory tuberculosis. Once diagnosed, the investigators will use target next generation sequencing to determine if the bacillus is resistant to any of the drugs used for treatment. Additionally, children initiated under TB treatment will be followed-up during treatment to measure blood biomarkers for outcome prediction. Finally, spirometry will be performed longitudinally until 3 months after the end of treatment to assess the lung capacity of children treated for respiratory TB. All children initiated on TB treatment will fill in a quality of life questionnaire.

Conditions

Tuberculosis

Keywords

pediatric TB; non-sputum diagnosis; post TB lung disease

Outcome Measures

Primary Outcomes (1)

• Stool diagnostic accuracy

  Evaluate the diagnostic accuracy of stool and perform targeted next generation sequencing from stool for drug sensitivity testing.

  at baseline

Secondary Outcomes (5)

• Biomarkers for treatment monitoring

  from baseline to 9 months pos-enrollment (6 months of treatment + 3 months follow-up post-treatment)

• Masks diagnostic accuracy

  baseline

• Urinary LAM diagnostic accuracy

  baseline

• Post-TB lung disease assessment

  from baseline to 9 months post-enrollment (6 months of treatment + 3 months follow-up post-treatment)

• Quality of life assessment

  from baseline to 9 months post-enrollment (6 months of treatment + 3 months follow-up post-treatment)

Eligibility Criteria

• Age: 0 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All potential participants presenting with the inclusion criteria, will be asked to participate in the study upon their parent/guardian consent and their assent, if applicable. Information will be provided about the study and the risks and benefits of participating. Both the child and the parent/guardian are then asked to consent (or assent) to the participation in the study and any questions they might have are answered. The enrollment is complete after the signature of the informed consent form (ICF). If the child or their parent/guardian does not wish to participate in the study, they will receive the standard of care.

You may qualify if:

• Children under 15 years evaluated for respiratory TB.
• Signature of the informed consent form by the parent/guardian and assent form by the child if applicable.

You may not qualify if:

• \- Refusal to sign informed consent

Sponsors & Collaborators

• Research Center Borstel: lead
• LMU Klinikum: collaborator

Study Sites (1)

Marius Nasta Institute of Pneumology

Bucharest, BUC, 050159, Romania

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples, mask samples (exhaled air), blood (for biomarkers only)

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Christoph Lange, Professor

  Research Center Borstel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anca Vasiliu, MD, PhD

CONTACT

+33652727749; avasiliu@fz-borstel.de

Dragos Baiceanu, MD

CONTACT

dragos_baiceanu@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: February 7, 2025
• Study Start: September 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 30, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: from 2024 to 2034
• Access Criteria: anyone contacting the study sponsor, upon written signature of a data sharing agreement

Locations

RO (1)