| CTRI Number |
CTRI/2024/11/076306 [Registered on: 05/11/2024] Trial Registered Prospectively |
| Last Modified On: |
27/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation of Therapeutic Drug Levels and Undernutrition among Adult Household Contacts of TB Patients on TB Preventive Therapy |
|
Scientific Title of Study
|
Therapeutic Drug Monitoring and Estimation of Undernutrition among Adult Household Contacts of TB Patients on TB Preventive Treatment |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Latha S |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of Pharmacology BLDE DU(s) shri B M Patil Medical College Hospital and research center, bangaramma sajjan campus, solhapur road Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9036282383 |
| Fax |
|
| Email |
lathas1224@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Latha S |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of Pharmacology BLDE DU(s) shri B M Patil Medical College Hospital and research center, bangaramma sajjan campus, solhapur road Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9036282383 |
| Fax |
|
| Email |
lathas1224@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Latha S |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of Pharmacology BLDE DU(s) shri B M Patil Medical College Hospital and research center, bangaramma sajjan campus, solhapur road Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9036282383 |
| Fax |
|
| Email |
lathas1224@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDE deemed to be university Shri B M Patil Medical College Hospital and Research Center Bagaramma sajjan campus Solhapur road Vijayapura Karnataka India 586103 |
|
|
Primary Sponsor
|
| Name |
BLDE deemed to be university |
| Address |
BLDE DU(s) shri B M Patil Medical College Hospital and research center, bangaramma sajjan campus, solhapur road Vijayapura Karnataka India 586103 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Latha S |
Shri B M Patil Medical College Hospital and Research Centre Vijayapura |
Room number 7 Department of Respiratory medicine
Bijapur
KARNATAKA |
9036282383
lathas1224@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adult household contacts of TB patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All adult aged more than 18years and are household contacts of TB patients put on TB preventive treatment of Drug sensitive TB patients
|
|
| ExclusionCriteria |
| Details |
People leaving with HIV on TB preventive treatment and Pregnant and lactation mothers on TB preventive treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Therapeutic drug levels among individuals on TB Preventive treatment |
After two hours of drug administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence of undernutrition among individuals on TB preventive treatment |
After two hours of drug administration |
|
|
Target Sample Size
|
Total Sample Size="196"
Sample Size from India="196"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TB
preventive treatment (TPT) is an effective and cost-effective intervention to
prevent progression from infection to disease and to reduce mortality due to
TB. The TPT with isoniazid in
countries like India currently covers only select groups of contacts like
children under 6 years of age and people living with HIV. WHO recently made a
conditional recommendation of offering TPT to all household contacts (HHC) i.e,
any person residing in the same
household as a TB patient of all ages. The burden of TB infection is the highest among household contacts. Apart
from being the largest burden of cases and deaths related to tuberculosis,
India also has undernutrition as leading risk factor accounting for TB
incidence and, undernutrition is a major common risk factor for mortality in
patients with TB in India. The
relationship between TB and nutrition is bidirectional, i.e. having
active TB leads to loss of weight, and being underweight is considered a risk
factor for developing TB, whether through reactivation of latent TB or
developing progressive primary disease upon infection. A systematic review of
literature showed that across a variety of settings with different levels of TB
burden, a strong and consistent log-linear relationship existed between BMI and
TB incidence - for each unit reduction in BMI the risk of TB increased by about
14 per cent. Different pathophysiological conditions in
undernutrition/malnutrition can alter the pharmacokinetics of drugs.
Gastrointestinal changes include hypochlorhydria, delayed gastrointestinal
emptying time, increased or decreased intestinal transit time, gastric and
mucosal atrophy and dysfunction, gastrointestinal inflammation, and pancreatic
insufficiency. In the enterocytes, P-glycoprotein activity is
decreased and tight junctions are enlarged, influencing the uptake of nutrients
and drugs. This pharmacokinetic variability is
one of the main causes for sub-optimal therapeutic drug concentration. Hence Therapeutic drug monitoring
is one of the best tools, to asses optimum drug concentration in such
conditions. Undernourishment leads to various micro and micronutrition
deficiency leading to alteration in the pharmacokinetic properties which in
tent leads to decreased therapeutic efficacy of drug taken for TB preventive
treatment. As HHC are at high risk of
developing the disease and importance of nutrition in TB is well established.
It is important to estimate optimum drug therapy through Therapeutic drug
monitoring and also estimate undernutrition among the adult household contacts of TB patients put
on TB preventive treatment to prevent infection to disease progression. |