| CTRI Number |
CTRI/2024/03/064108 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study of N-acetyl cysteine therapy in patients with lung tuberculosis |
|
Scientific Title of Study
|
N-acetyl cysteine therapy in patients with Pulmonary tuberculosis: A Pilot Open- Label Randomized 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 |
Saurabh Mittal |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 2, Porta Cabin, 3rd floor, NPW, AIIMS, Delhi
Delhi
South
DELHI
110029
India |
| Phone |
01126546357 |
| Fax |
|
| Email |
saurabh_kgmu@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Saurabh Mittal |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 2, Porta Cabin, 3rd floor, NPW, AIIMS, Delhi
Delhi
DELHI
110029
India |
| Phone |
01126546357 |
| Fax |
|
| Email |
saurabh_kgmu@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Saurabh Mittal |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 2, Porta Cabin, 3rd floor, NPW, AIIMS, Delhi
Delhi
DELHI
110029
India |
| Phone |
01126546357 |
| Fax |
|
| Email |
saurabh_kgmu@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Biotechnology, Govt. of India |
|
|
Primary Sponsor
|
| Name |
Dr Saurabh Mittal |
| Address |
Room no. 2, Porta Cabin, third floor, New Pvt Ward, AIIMS, New Delhi |
| Type of Sponsor |
Other [Assistant Professor, Department of Pulmonary, Critical Care and Sleep Medicine, AIIMS, Delhi] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Anant Mohan |
Room no. 5, Porta Cabin, third floor, New Pvt Ward, AIIMS, New Delhi |
| Dr Karan Madan |
Room no. 7, Porta Cabin, third floor, New Pvt Ward, AIIMS, New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saurabh Mittal |
All India Institute of Medical Sciences |
Room no. 2, Porta Cabin, 3rd floor, NPW, AIIMS, Delhi
Delhi
South
DELHI |
01126546357
saurabh_kgmu@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi |
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 |
N-Acetyl Cysteine |
Tablets, 600 mg twice daily for six months |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 years or more.
2. Willing to give written informed consent.
3. Body weight ≥ 30 kg.
4. Pulmonary TB diagnosed with One sputum OR Bronchoalveolar lavage GeneXpert test positive.
5. No detection of Rifampicin resistance by GeneXpert/ LPA/ MGIT C/S.
6. A chest radiograph abnormality consistent with tuberculosis.
7. No prior history of ATT.
8. Willing to undergo HIV serology testing.
9. Agrees to use effective barrier contraception during the period of the study.
10. Residing around the study site (AIIMS, Delhi).
11. Express willingness to attend the treatment center for supervised treatment.
12. Express willingness to adhere to the trial procedures and follow-up schedule.
|
|
| ExclusionCriteria |
| Details |
1. Clinically significant evidence of extrapulmonary TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis).
2. Poor general condition as assessed by the study investigator.
3. Renal dysfunction including (but not limited to) serum creatinine levels above the upper limit of the laboratory reference range (Serum creatinine >1.2 mg/dL or blood urea >43 mg/dL)
4. Has clinical jaundice or hepatic impairment characterized by serum bilirubin level above 1.2 times upper limit of the laboratory reference range, or by alanine aminotransferase (ALT) and/ or aspartate aminotransferase (AST) levels >3 times the upper limit of the laboratory reference range
5. Diabetes mellitus or Psychiatric illness
6. Serology positive for HBSAg Or Hepatitis C virus antibody Or HIV
7. Pregnant or lactating females
8. Has any condition (social or medical) which in the opinion of the investigator would make trial participation unreliable or unsafe
9. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
10. Has a known allergy to any of the drugs proposed to be used in the trial regimen
11. Has evidence of clinically significant metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The change in pre-bronchodilator FVC and FEV1 between the two groups at 2 months from baseline |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The proportion of patients having radiological improvement/stabilisation at two months and six months |
2 months and 6 months |
| The proportion of patients having sputum/ BAL culture negativity at two weeks |
Two weeks |
| The change in pre-bronchodilator FVC and FEV1 between the two groups at 6 months |
6 months |
| To compare the change in biomarkers of oxidative stress & inflammation at 2 month between NAC containing arm and the control arm |
2 months |
| The proportion of patients having “unfavorable outcome†at 6 months (defined as composite of radiologically active disease, sputum culture positive, death due to tuberculosis and NAC discontinuation) |
6 months |
| The proportion of patients having IGRA positivity at the end of 6 months |
6 months |
| The number of adverse events between the NAC containing arm and control arm during 6 months of therapy |
6 months |
|
|
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)
|
01/04/2024 |
| 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="2"
Months="0"
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
|
Introduction: Current treatment strategies in Pulmonary TB are
effective in curing the disease but have several problems, including residual lung damage as evidenced by
spirometry and radiological changes. There is also a significant risk of relapse of disease due to persisters.
Hypothesis: We hypothesize that using NAC with ATT causes reduction in lung
destruction, preservation of lung
function, and early sputum sterilization in pulmonary tuberculosis. Objectives: To assess
the change in FVC and FEV1
at two months of therapy.
Other objectives include microbiological clearance,
radiological improvement, change in biomarkers, and quality of life. Methods: Pilot open-label randomized controlled trial of addition of NAC to
standard ATT during six months
therapy for pulmonary tuberculosis. All patients will be followed up with
serial spirometry, chest radiograph, six-minute walk test, and St. George’s respiratory questionnaire to assess the quality
of life. |