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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05664568
Registration number
NCT05664568
Ethics application status
Date submitted
2/11/2022
Date registered
23/12/2022
Date last updated
26/06/2023
Titles & IDs
Public title
The BLAST- 1 Trial - Cephalexin+Amoxicillin-clavulanate for Tuberculosis
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Scientific title
Early Bactericidal Activity of Cephalexin and Amoxicillin-clavulanate for Susceptible Tuberculosis - BLAST 1 Trial
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Secondary ID [1]
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2022/PID01942
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Universal Trial Number (UTN)
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Trial acronym
BLAST
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Tuberculosis, Pulmonary
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Condition category
Condition code
Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cephalexin
Treatment: Drugs - Amoxicillin-Clavulanate 500 Mg-125 Mg Oral Tablet
Other interventions - Standard of care treatment of tuberculosis
Active comparator: Standard of care TB - Standard of care treatment for TB (rifampicin, isoniazid, ethambutol and pyrazinamide according to WHO)
Experimental: Cephalexin + amoxicillin-clavulanate - Intervention arm: cephalexin 1g thrice daily + amoxicillin-clavulanate 500/125 mg thrice daily.
Treatment: Drugs: Cephalexin
Participants in intervention group will receive a combination of cephalexin and amoxicillin-clavulanate for the first 2 weeks of TB treatment
Treatment: Drugs: Amoxicillin-Clavulanate 500 Mg-125 Mg Oral Tablet
Participants in the intervention group will receive a combination of cephalexin and amoxicillin-clavulanate for the first 2 weeks of TB treatment
Other interventions: Standard of care treatment of tuberculosis
The control group will be given standard of care treatment of tuberculosis consisting of rifampicin, isoniazid, pyrazinamide and ethambutol
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to positivity (TTP)
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Assessment method [1]
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Early bactericidal activity measured as fall in time to positivity (TTP)
1. The primary outcome is fall in bacterial load in sputum, measured as the rate of change in Time to Sputum Culture Positivity (TTP). TTP is the time to a positive culture when sputum samples are incubated in BACTEC MGIT for automated detection of M. tuberculosis. Measuring the fall in bacterial load is standard choice of outcome for studies evaluating the effect (kill) of drug on TB bacteria.
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Timepoint [1]
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2 weeks
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Secondary outcome [1]
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Adverse events
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Assessment method [1]
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Tolerability - frequency, categorization and grade of adverse events according to CTCAE (Common Terminology Criteria for Adverse Events)
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Timepoint [1]
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2 weeks
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Secondary outcome [2]
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Area under the concentration versus time curve (AUC) of cephalexin
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Assessment method [2]
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Estimation of the pharmacokinetic parameter area under the concentration versus time curve (AUC) of cephalexin in saliva.
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Timepoint [2]
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2 weeks
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Secondary outcome [3]
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Cmax of cephalexin
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Assessment method [3]
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Estimation of the pharmacokinetic parameter maximum concentration (Cmax) of cephalexin saliva.
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Timepoint [3]
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2 weeks
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Eligibility
Key inclusion criteria
* Consenting adults (=18 years)
* =40 kg
* Smear-positive patients with active tuberculosis, confirmed by sputum smear, TB PCR and/or GeneXpert.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2024
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Blacktown Hospital - Sydney
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Recruitment hospital [2]
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Royal Prince Alfred Hospital - Sydney
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Recruitment hospital [3]
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Western Sydney Health District - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
Western Sydney Local Health District
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Centre Of Research Excellence in Tuberculosis Control
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief 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).
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Trial website
https://clinicaltrials.gov/study/NCT05664568
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jan-Willem Alffenaar, Professor
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Address
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WSLHD, Department of Pharmacy, Westmead hospital, NSW, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jan-Willem Alffenaar, Professor
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Address
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Country
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Phone
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+61 (0)286270019
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05664568
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