| CTRI Number |
CTRI/2024/01/061473 [Registered on: 15/01/2024] Trial Registered Prospectively |
| Last Modified On: |
21/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of doxycycline in tuberculosis (TB) patients |
|
Scientific Title of Study
|
Efficacy of doxycycline as an add on therapy in drug sensitive cavitary pulmonary tuberculosis patients- A randomized placebo controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maheshwari P |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
| Address |
Department of Pharmacology, Institute block, JIPMER, Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9952947583 |
| Fax |
|
| Email |
maheshwariesic2k16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mirunalini R |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
| Address |
Department of Pharmacology, Institute block, JIPMER, Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7397164730 |
| Fax |
|
| Email |
acadcon2019@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mirunalini R |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
| Address |
Department of Pharmacology, Institute block, JIPMER, Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7397164730 |
| Fax |
|
| Email |
acadcon2019@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Research Fund Jawaharlal Institute of Postgraduate Medical Education & Research |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education & Research |
| Address |
JIPMER Campus Road, Gorimedu, Dhanvantari Nagar, Puducherry,
605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Maheshwari P |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
JIPMER Campus Road,
Gorimedu, Dhanvantari
Nagar, Puducherry,
605006
Pondicherry
PONDICHERRY |
9952947583
maheshwariesic2k16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A150||Tuberculosis of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capsule Doxycycline |
Capsule Doxycycline 100mg twice a day for 4 weeks |
| Comparator Agent |
Placebo |
Placebo 100mg twice a day for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Females (who have completed their family or undergone sterilization)and males- who were newly diagnosed clinically and microbiologically confirmed drug sensitive pulmonary tuberculosis patients who have been receiving anti-tubercular
therapy for ≤ 7days or about to start standard
ATT with chest X-Ray demonstrating pulmonary
cavity/cavities |
|
| ExclusionCriteria |
| Details |
Patients with extra pulmonary tuberculosis, previous history of pulmonary TB, HIV coinfections, severe preexisting lung diseases
(such as fibrosis, COPD, lung cancer, bronchiectasis) and autoimmune diseases
Patients with ALT/ AST >3 times upper limit of
normal
Patients with Creatinine > 2 times upper limit of
normal
Patient on antiepileptic therapy
Known hypersensitivity to tetracyclines
Patients who have taken tetracycline in the past
30 days preceding the dosing of study drug
Patient who participated in other clinical trials in past 180 days |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Matrix metalloproteinase 1 |
Baseline, 1month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cumulative lung cavity volume, wall thickness, lobe involvement, CT severity score using Low dose Chest CT |
Baseline, 6months |
| Matrix Metalloproteinases 3,8 |
Baseline, 1month |
| Pulmonary function test |
6 months |
| Sputum microscopy/ culture |
Baseline, end of intensive therapy, end of tuberculosis therapy |
| Quality of life using St George Respiratory Questionnaire |
Baseline, 6months |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Following approval from PGRMC, State operational research
committee and Institutional Ethics Committee, trial is registered in CTRI
following which enrolment of the patient will begin based on the eligibility
criteria after obtaining written informed consent. Patient will then be
assessed for the baseline parameters like age, BMI, comorbidities,
socioeconomic status, occupation, nutritional history, sputum microscopy/
culture, will be assessed and baseline blood parameters like low dose chest CT,
CBC, RFT, LFT, RBS, MMP-1,3,8 will be measured and St George respiratory
questionnaire will be administered. Patient will be randomly allocated to take
capsule doxycycline 100mg or placebo twice daily for 4weeks. Adherence and
adverse effects will be enquired over phone and adherence also ensured by pill
count method. At the end of 4weeks blood sample will be collected for CBC, RFT,
LFT, RBS, MMP-1,3,8. At the end of TB therapy (6months) patient will be
repeated with low dose chest CT, St George respiratory questionnaire and
spirometry will also be done. Sputum microscopy/ culture will be done at the
end of intensive therapy and at the end of TB therapy. If patient develops any
adverse events will be monitored and treated accordingly. Both per- protocol
and intention to treat analysis will be performed. |