A Randomised Placebo - Controlled Double Blind Trial Comparing 1) a Two Month Intensive Phase of Ethambutol, Moxifloxacin, Rifampicin, Pyrazinamide Versus the Standard Regimen (Ethambutol, Isoniazid, Rifampicin, Pyrazinamide) and 2) a Treatment Shortening Regimen Comparing Two Months Moxifloxacin, Isoniazid, Rifampicin, Pyrazinamide Followed by Two Months Moxifloxacin, Isoniazid, Rifampicin Versus the Standard Regimen (Two Months Ethambutol, Isoniazid, Rifampicin, Pyrazinamide Followed by Four Months Isoniazid and Rifampicin) for the Treatment of Adults With Pulmonary Tuberculosis

Not Applicable

• Conditions: -A15 Respiratory tuberculosis, bacteriologically and histologically confirmed; Respiratory tuberculosis, bacteriologically and histologically confirmed; A15

• Registration Number: PER-098-09
• Lead Sponsor: niversity College London,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-11
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

• Signed written consent or witnessed oral consent in the case of illiteracy, before undertaking any trial related activity.
• Two sputum specimens positive for tubercle bacilli on smear microscopy at least one of which must be processed and positive at the study laboratory.
• Aged 18 years or over.
• No previous anti-tuberculosis chemotherapy.
• 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.
• Agreement to participate in the study and to give a sample of blood for HIV testing (see appendices 1 & 2).
• Pre-menopausal women must be using a barrier form of contraception or be surgically sterilised or have an IUCD in place.
• Laboratory parameters performed up to 14 days before enrolment.
• Negative pregnancy test (women of childbearing potential).

Exclusion Criteria

• Unable to take oral medication.
• Previously enrolled in this study.
• Received any investigational drug in the past 3 months.
• Received an antibiotic active against M. tuberculosis in the last 14 days (fluoroquinolones, macrolides, standard anti-tuberculosis drugs).
• Any condition that may prove fatal during the first two months of the study period.
• TB meningitis or other forms of severe tuberculosis with high risk of a poor outcome
• 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.
• Pregnant or breast feeding.
• Suffering from a condition likely to lead to uncooperative behaviour e.g. psychiatric illness or alcoholism.
• Contraindications to any medications in the study regimens.
• 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).
• Known allergy to any fluoroquinolone antibiotic or history of tendinopathy associated with quinolones.
• Patients already receiving anti-retroviral therapy.
• 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)
• Weight less than 35kg
• HIV infection with CD4 count less than 250 cells/µL.
• End stage liver failure (class Child-Pugh C).

Study & Design

• Study Type: Interventional
• Study Design: Not specified