The BLAST- 1 Trial - Cephalexin+Amoxicillin-clavulanate for Tuberculosis (BLAST)
Tuberculosis, Pulmonary
About this trial
This is an interventional treatment trial for Tuberculosis, Pulmonary focused on measuring Randomized controlled trial, Early bactericidal activity, Smear-positive TB, Betalactam antibiotics, Cephalosporin, Time to positivity
Eligibility Criteria
Inclusion Criteria: Consenting adults (≥18 years) ≥40 kg Smear-positive patients with active tuberculosis, confirmed by sputum smear, TB PCR and/or GeneXpert. Exclusion Criteria: On TB treatment for >1 day Condition affecting ability of an informed consent (i.e. dementia, delirium etc). Pregnancy or breast-feeding HIV Known allergy or sensitivity to any of the study drugs Drug-resistant TB (resistance to rifampicin and/or isoniazid) Poor general condition or severe infection such that, in the opinion of the investigator at screening, any delay in initiation of definitive TB treatment cannot be tolerated TB with concomitant central nervous system and/or cardiac involvement. Any condition as determined by physical examination, medical history, laboratory data, or chest x-ray which, in the opinion of the investigator, would interfere with safety or endpoint assessments in the study. Use of metformin, probenecid or allopurinol Known previous Clostridium difficile infection due to the risk of colitis. (In case no medical records are available, it should be suspected in elderly patients reporting severe gastrointestinal infections in relation to courses of antibiotics)
Sites / Locations
- Blacktown Hospital
- Royal Prince Alfred Hospital
- Western Sydney Health DistrictRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard of care TB
Cephalexin + amoxicillin-clavulanate
Standard of care treatment for TB (rifampicin, isoniazid, ethambutol and pyrazinamide according to WHO)
Intervention arm: cephalexin 1g thrice daily + amoxicillin-clavulanate 500/125 mg thrice daily.