Controlled comparison of two moxifloxacin containing treatment shortening regimens in pulmonary tuberculosis [retrospectively registered]

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201110000124315
• Date of registration: 10/02/2009
• Primary sponsor: Centre for Medical Microbiology , Royal Free and University College Medical School, Hampstead Campus, Rowland Hill Street
• Public title: Controlled comparison of two moxifloxacin containing treatment shortening regimens in pulmonary tuberculosis [retrospectively registered]
• Scientific title: REMoxTB
• Date of first enrolment: 2008-01-01
• Recruitment status: Open to recruitment: actively recruiting participa
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201110000124315
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Randomised,; Permuted block randomisation: blocks of variable size,; Allocation was determined by the holder of the sequence who is situated off site,

Countries of recruitment

South Africa

Contacts

• Name: Matt Betteridge

• Name: Matt Betteridge
• Affiliation: Senior Trial Manager

Key inclusion & exclusion criteria

Inclusion criteria: 1. Signed written consent or witnessed oral consent in the case of illiteracy, before undertaking any trial related activity
2. Two sputum specimens positive for tubercle bacilli on direct smear microscopy at the local laboratory
3. No previous anti-tuberculosis chemotherapy
4. Aged 18 years and over
5. 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
6. Agreement to participate in the study and to give a sample of blood for Human Immunodeficiency Virus (HIV) testing
7. Laboratory parameters performed up to 14 days before enrolment
8. Serum aspartate aminotransferase (AST) activity less than three times the Upper Limit of Normal (ULN)
9. Serum total bilirubin level less than 2.5 times ULN
10. Creatinine Clearance (CrCl) level greater than 30 mls/min
11. Haemoglobin level of at least 7.0 g/dL
12. Platelet count of at least 50 x 10^9 cells/L
13. Serum potassium greater than 3.5 mmol/L
14. Negative pregnancy test (women of childbearing potential)
15. Pre-menopausal women must be using a barrier form of contraception or be surgically sterilised or have an Intra-Uterine Contraceptive Device (IUCD) in place
Exclusion criteria: 1. Unable to take oral medication
2. Previously enrolled in this study
3. Received any investigational drug in the past three months
4. Received an antibiotic active against M. tuberculosis in the last 14 days (fluoroquinolones, macrolides, standard anti-tuberculosis drugs)
5. Any condition that may prove fatal during the first two months of the study period
6. TB meningitis or other forms of severe tuberculosis with high risk of a poor outcome
7. Pre-existing non-tuberculosis disease likely to prejudice the response to, or assessment of, treatment e.g. insulin-dependent diabetes, liver or kidney disease, blood disorders, peripheral neuritis, chronic diarrhoeal disease
8. Pregnant or breast feeding
9. Suffering from a condition likely to lead to uncooperative behaviour e.g. psychiatric illness or alcoholism
10. Contraindications to any medications in the study regimens
11. 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)
12. End stage liver failure (class Child-Pugh C)
13. Uncorrected hypokalaemia
14. Weight less than 35 kg
15. Known allergy to any fluoroquinolone antibiotic or history of tendinopathy associated with quinolones
16. HIV infection with CD4 count less than 250 x 10^9/lit
17. Patients already receiving anti-retroviral therapy
18. Patients whose initial isolate is shown to be multiple drug resistant

Age minimum: 18 null
Age maximum: 999 null
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis
null

Primary Outcome(s)

1. Efficacy : Combined failure of bacteriological cure and relapse within one year of completion of therapy 2. Safety: Proportion of patients with grade three or four Adverse Events (AE's) according to the World Health Organisation (WHO) grade

Source(s) of Monetary Support

Bayer HealthCare Pharmaceuticals (USA)

European and Developing Countries Clinical Trials Partnership

TB Alliance (USA)