NCT06666972

Brief Summary

  • Detection of sensitivity and specificity of microscopic examination and Molecular studies using polymerase chain reaction (PCR) Mycobacterium tuberculosis (MTB)/ non tuberculous mycobacterium (NTM) MDR-TB compared to culture which is the gold standard technique in the diagnosis of TB to reach the most reliable one for better health care service.
  • Assess the prevalence of tuberculosis cases among clinically suspected cases admitted to the hospital throughout the selected study period.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Jan 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jan 2025Sep 2026

First Submitted

Initial submission to the registry

October 29, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

12 months

First QC Date

October 29, 2024

Last Update Submit

November 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • *Compare between different available tests to reach the most reliable one for better health care service.

    \*Detection of sensitivity and specificity of microscopic examination and Molecular studies using PCR MTB/NTM MDR-TB compared to culture which is the gold standard technique in the diagnosis of TB to reach the most reliable one for better health care service.

    two years

Secondary Outcomes (1)

  • *Assess the prevalence of tuberculosis cases among clinically suspected cases admitted to the hospital throughout the selected study period.

    two years

Interventions

PCR MTB/NTMDIAGNOSTIC_TEST

• The Polymerase chain reaction (PCR) MTB/NTM MDR-TB test is an innovative technology that offers a cutting-edge approach to the precise diagnosis of tuberculosis and nontuberculous mycobacterial infections (NTM).

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with signs and symptoms of tuberculosis (suspected cases) and Patients diagnosed with tuberculosis of both sexes admitted to Assiut university hospitals

You may qualify if:

  • Patients with signs and symptoms of tuberculosis (suspected cases)
  • Patients diagnosed with tuberculosis.

You may not qualify if:

  • Patients with pulmonary infections other than TB

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Rakotosamimanana N, Rabodoarivelo MS, Palomino JC, Martin A, Razanamparany VR. Exploring tuberculosis by molecular tests on DNA isolated from smear microscopy slides. Int J Infect Dis. 2017 Mar;56:248-252. doi: 10.1016/j.ijid.2016.12.005. Epub 2016 Dec 12.

    PMID: 27979786BACKGROUND

Central Study Contacts

Mahmoud Abdou Abdelmoula

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical pathology specialist

Study Record Dates

First Submitted

October 29, 2024

First Posted

October 31, 2024

Study Start

January 1, 2025

Primary Completion

December 30, 2025

Study Completion (Estimated)

September 30, 2026

Last Updated

November 5, 2024

Record last verified: 2024-11