The BLAST- 1 Trial - Cephalexin+Amoxicillin-clavulanate for Tuberculosis
Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
The goal of this randomized controlled trial is to study the early bactericidal activity in
adult patients with smear-positive pulmonary tuberculosis.
The main question it aims to answer are if cephalexin, in combination with
amoxicillin-clavulanate, is effective in the treatment of tuberculosis.
Participants with smear-positive tuberculosis will be randomized to either of two groups:
Intervention group: cephalexin and amoxicillin-clavulanate. Control group: Standard of care
TB treatment. The study period is 2 weeks and participants will be asked to submit multiple
sputum samples to measure the bacterial sputum load. They will also submit saliva samples for
estimation of drug concentrations in the body.
Researchers will compare the intervention group with the control group to see if the trial
drugs result in a reduced bacterial sputum load
Overall aim: To study the early bactericidal activity of cephalexin, in combination with
amoxicillin-clavulanate, in comparison to standard treatment in patients with active
pulmonary tuberculosis during the first 2 weeks of treatment.
Primary aim:
1. To evaluate the early bactericidal activity (measured as 'time to culture positivity')
of cephalexin-clavulanate in comparison, to standard TB treatment (rifampicin,
isoniazid, pyrazinamide, and ethambutol).
Secondary aim:
2. To asses safety and tolerability of cephalexin together with amoxicillin-clavulanate.
3. To determine key pharmacokinetic (PK) parameters of cephalexin, especially half-life and
drug exposure (maximal concentration; Cmax and area under the concentration versus time
curve, AUC).
Phase:
Phase 2
Details
Lead Sponsor:
Western Sydney Local Health District
Collaborator:
Centre Of Research Excellence in Tuberculosis Control