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Not yet recruitingNCT06700577Updated Nov 22, 2024

Multidrug Resistance in Newly Diagnosed TB Patient

An observational study in Tuberculosis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-22.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years and older
Sex
All
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Study summary

Tuberculosis (TB) is one of the major public health threats, competing with the human immunodeficiency virus (HIV) as the cause of death due to infectious diseases worldwide.

Multi drug-resistant Mycobacterium tuberculosis (MDR-TB) is one of the leading causes of death in the world.

The resource constraints make it difficult to diagnose and monitor the cases of MDR-TB.

GeneXpert is a recognized tool used to diagnose the patients of pulmonary tuberculosis in clinical settings across the globe MDR Multidrug-resistant tuberculosis (MDR-TB), caused by Mycobacterium tuberculosis that is resistant to both isoniazid and rifampicin with or without resistance to other drugs According to current World Health Organization and the International Union Against Tuberculosis and Lung Disease estimates, the median prevalence of MDR-TB has been 1.1% in newly diagnosed patients. The proportion, however, is considerably higher (median prevalence, 7%) in patients who have previously received anti-TB treatment.

XDR tuberculosis is caused by a strain of Mycobacterium tuberculosis resistant to isoniazid and rifampin (which defines MDR tuberculosis) in addition to any fluoroquinolone and at least one of the three following injectable drugs: capreomycin, kanamycin, and amikacin The main causes of the spread of resistant TB are weak medical Systems, amplification of resistance patterns through incorrect treatment, and transmission in communities and facilities. Although patients harboring MDR and XDR strains present a formidable challenge for treatment, cure is often possible with early identification of resistance and use of a properly designed regimen.

Read the detailed description

To detect the prevalence of MDR T.B. using xpert MTB/RIF ultra and XDR assay in newly diagnosed cases

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Conditions studied

  • Tuberculosis

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In context

Tuberculosis

1,435 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's planned enrollment of 100 is below the median of 240 across 427 observational studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All newly diagnosed TB patient above 18 years who not recieved antituberculus drug before

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • newly diagnosed tuberculosis patient
  • Diagnosed by direct smear for sputum or body fluid

Exclusion criteria

Exclusion Criteria:

* previously treated patient

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Study design

Observational model
Case-crossover
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testGene expert

    Gene expert and XDR to detect multidrug resistance between tb patient

  • GeneticUltra xpert and xdr xpert

    Detect resistance between tyberculous patient

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What researchers measure

Primary outcomes

  1. To detect the prevalence of multidrug resistant tuberculosis in newly diagnosed cases by xpert XDR assay.

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Seung KJ, Keshavjee S, Rich ML. Multidrug-Resistant Tuberculosis and Extensively Drug-Resistant Tuberculosis. Cold Spring Harb Perspect Med. 2015 Apr 27;5(9):a017863. doi: 10.1101/cshperspect.a017863. PubMed 25918181 ↗

Related links

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2024; primary completion for Oct 2025, 10 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2024
First posted
Nov 22, 2024
StartEst.
Dec 2024
Primary completionEst.
Oct 2025
CompletionEst.
Nov 2025
Last update
Nov 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06700577
Lead sponsor
Assiut University
Responsible party
Fatma nashat esmail zyada (Pulomongist , principale investigator , Resident doctor, Assiut University) — Principal investigator
First posted
Nov 22, 2024
Start date
Dec 2024 (estimated)
Primary completion
Oct 2025 (estimated)
Completion
Nov 2025 (estimated)
Last update
Nov 22, 2024

Study contacts

Fatma Nashat esmail zyada Resident doctor
Contact
nashatfatma209@gmail.com
0201033865906

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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