Cephalexin and Amoxicillin-Clavulanate for Treating Tuberculosis
Early Bactericidal Activity of Cephalexin and Amoxicillin-clavulanate for Susceptible Tuberculosis - BLAST 1 Trial
This study is testing if a combination of two antibiotics, cephalexin and amoxicillin-clavulanate, can help adults with active tuberculosis get better faster than standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Western Sydney Local Health District Academic / other |
| Locations | 3 sites (Sydney and 2 other locations) |
| Trial ID | NCT05664568 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the early bactericidal activity of cephalexin combined with amoxicillin-clavulanate in adult patients with smear-positive pulmonary tuberculosis. Participants will be randomly assigned to receive either the combination treatment or standard TB care for two weeks. Throughout the trial, multiple sputum and saliva samples will be collected to assess bacterial load and drug concentrations. The primary outcome will be the reduction in bacterial load measured by the time to positive culture using the BACTEC MGIT system.
Who should consider this trial
Good fit: Ideal candidates are consenting adults aged 18 and older with smear-positive active tuberculosis.
Not a fit: Patients who are already on TB treatment for more than one day or have drug-resistant TB will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and well-tolerated option for patients with tuberculosis.
How similar studies have performed: While this approach is novel in the context of tuberculosis treatment, previous studies have shown the efficacy of these antibiotics against TB bacteria in vitro.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Sydney and 2 other locations
- Blacktown Hospital — Sydney, Australia (Not_yet_recruiting)
- Royal Prince Alfred Hospital — Sydney, Australia (Not_yet_recruiting)
- Western Sydney Health District — Sydney, Australia (Recruiting)
Study contacts
- Principal investigator: Jan-Willem Alffenaar, Professor — WSLHD, Department of Pharmacy, Westmead hospital, NSW, Australia
- Study coordinator: Jan-Willem Alffenaar, Professor
- Email: johannes.alffenaar@nsw.health.gov.au
- Phone: +61 (0)286270019
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.