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UNDERSTANDING DRUG RESISTANCE IN PATIENTS WITH EXTRAPULMONARY TUBERCULOSIS AT A RURAL HOSPITAL

TO STUDY THE PATTERN OF DRUG RESISTANCE IN PATIENTS PRESENTING WITH EXTRAPULMONARY TUBERCULOSIS AT ACHARYA VINOBA BHAVE RURAL HOSPITAL - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/06/088090
Enrollment
45
Registered
2025-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J00-J99- Diseases of the respiratory system

Interventions

Control Intervention1: NIL: NIL

Sponsors

Datta Meghe Institute Of Higher education Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All adult patients presenting with extra pulmonary tuberculosis

Exclusion criteria

Exclusion criteria: 1) Patients not willing to give consent for the study 2) Non compliant patient

Design outcomes

Primary

MeasureTime frame
1) Determine the prevalence of drug-resistant strains in patients with extra pulmonary tuberculosis at the time of diagnosis. 2) Identify the specific resistance patterns (e.g., mono-resistance, MDR-TB, XDR-TB) to first-line and second-line anti-TB drugs. 3) Assess the distribution of resistance across different types of extra pulmonary TB (e.g., lymph node TB, Pleural TB, spinal TB, etc.).Timepoint: 1) At diagnosis (baseline/enrollment). 2) At diagnosis (based on drug sensitivity testing results collected at enrollment). 3) At diagnosis (using clinical and microbiological data available at enrollment).

Secondary

MeasureTime frame
1) Prevalence of mono-resistance, poly-resistance, MDR-TB, and XDR-TB among EPTB patients. 2)Association between drug resistance patterns and type/site of EPTB (e.g., lymph node, pleural, meningeal). 3)Correlation of drug resistance with patient factors such as HIV status, previous TB treatment, comorbidities, and demographic data. 4)Diagnostic yield of various tests (CBNAAT, Line Probe Assay, Culture and DST) in detecting drug resistance in EPTB. 5)Time interval from clinical presentation to confirmed diagnosis of drug resistance. Timepoint: 1)Day 0 (Baseline): Patient enrollment, demographic and clinical data collection. Collection of samples from EPTB sites. Initiation of diagnostic tests (CBNAAT, LPA, Culture/DST). 2)Within 2 Weeks: Results of CBNAAT and LPA (rapid molecular diagnostics). 3)6 8 Weeks: Culture and phenotypic DST results available. 4)Monthly Follow-Up (up to 6 or 12 months, as applicable): 5)Monitoring clinical response, adverse drug reactions, and treatment outcomes.

Countries

India

Contacts

Public ContactDr Beeravolu Harshith Reddy

Datta Meghe Institute of Higher Education and Research

crownbabaji@gmail.com9822342770

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026