A trial comparing two treatment shortening regimens with the standard anti tuberculosis treatment regimen for the treatment of adults with pulmonary tuberculosis

Phase 3

Completed

• Conditions: Health Condition 1: null- Treatment naive Tuberculosis patient

• Registration Number: CTRI/2011/05/001745
• Lead Sponsor: Apothecaries Private limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1900

Inclusion Criteria

A. Signed written consent or witnessed oral consent in the case of illiteracy,

before undertaking any trial related activity.

B. Two sputum specimens positive for tubercle bacilli on smear microscopy at least one of which must be processed and positive at the study laboratory.

C. Aged 18 years or over.

D. No previous anti-tuberculosis chemotherapy.

E. A firm home address that is readily accessible for visiting and willingness to

inform the study team of any change of address during the treatment and follow-up period.

F. Agreement to participate in the study and to give a sample of blood for HIV testing (see appendices 1 & 2).

G. Pre-menopausal women must be using a barrier form of contraception or be surgically sterilised or have an IUCD in place.

H. Laboratory parameters performed up to 14 days before enrolment. ?h Serum aspartate transaminase (AST) and alanine transaminase (ALT)

activity less than 3 times the upper limit of normal ?h Serum total bilirubin level less than 2.5 times upper limit of normal

?h Creatinine clearance (CrCl) level greater than 30 mls/min ?h Haemoglobin level of at least 7.0 g/dL ?h Platelet count of at least 50x109cells/L ?h Serum potassium greater than 3.5 mmol/L

I. Negative pregnancy test (women of childbearing potential).

Exclusion Criteria

A. Unable to take oral medication.

B. Previously enrolled in this study.

C. Received any investigational drug in the past 3 months.

D. Received an antibiotic active against M. tuberculosis in the last 14 days

(fluoroquinolones, macrolides, standard anti-tuberculosis drugs).

E. Any condition that may prove fatal during the first two months of the study

period.

F. TB meningitis or other forms of severe tuberculosis with high risk of a poor

outcome.

G. Pre-existing non-tuberculosis disease e.g. diabetes, liver or kidney disease,

blood disorders, peripheral neuritis, chronic diarrhoeal disease in which the

current clinical condition of the patient is likely to prejudice the response to,

or assessment of treatment.

H. Pregnant or breast feeding.

I. Suffering from a condition likely to lead to uncooperative behaviour e.g.

psychiatric illness or alcoholism.

J. Contraindications to any medications in the study regimens.

K. Known to have congenital or sporadic syndromes of QTc prolongation or

receiving concomitant medication reported to increase the QTc interval (e.g.

amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine).

L. Known allergy to any fluoroquinolone antibiotic or history of tendinopathy

associated with quinolones.

M. Patients already receiving anti-retroviral therapy.

N. Patients whose initial isolate is shown to be multiple drug resistant (i.e.

resistant to rifampicin and isoniazid) or monoresistant to rifampicin, or

resistant to any fluoroquinolone). (See Section 5.9.2)

O. Weight less than 35kg.

P. HIV infection with CD4 count less than 250 cells/μL.

Q. End stage liver failure (class Child-Pugh C).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Efficacy:<br>Combined failure of bacteriological cure and relapse within one year of<br>completion of therapy as defined by culture using solid media.<br>2. Safety:<br>Both comparisons: Proportion of patients with grade 3 or 4 adverse events.Timepoint: 1.5 years

Secondary Outcome Measures

Name	Time	Method
Efficacy:<br>1. Combined failure of bacteriological cure and relapse within one year of<br>completion of therapy as defined by culture using liquid media<br>The following endpoints will be measured separately using both solid and liquid<br>media.<br>2. Sensitivity analyses assuming all losses to follow-up and non-tuberculous<br>deaths have an unfavourable outcome.<br>3. Sensitivity analyses assuming all losses to follow-up and non-tuberculous<br>deaths have a favourable outcome.<br>4. Proportion of patients who are culture negative at eight weeks.<br>5. Time to first culture negative sputum sample.<br>6. Speed of decline of sputum viable count.Timepoint: 1.5 years