TuberculosisPhase 1NCT02393586
Whole Blood Bactericidal Activity (WBA) Against Mycobacterium Tuberculosis of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers
A Phase 1 study testing Faropenem, Amoxicillin/clavulanic acid 500mg/125mg and Rifampicin in people with Tuberculosis, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The purpose of this study is to evaluate the bactericidal activity against Mycobacterium tuberculosis of faropenem boosted with amoxicillin/clavulanic acid. Pharmacokinetics (PK) and Whole blood Bactericidal Activity (WBA) will be measured in healthy volunteers following single doses of faropenem plus… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Faropenem, Amoxicillin/clavulanic acid 500mg/125mg and Rifampicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2015to Oct 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 21 and above
- Male or female willing to comply with the study visits and procedures
- Willing and able to provide written informed consent
Who cannot join
- Women who are currently pregnant or breastfeeding
- Signs of active TB
- Previous hypersensitivity or allergy to rifampicin, faropenem or other beta-lactam drugs (penicillins, carbapenems)
- Current use of any drugs or medications known to have an interaction with any of the study drugs
- Current use of any other drugs, over the counter or herbal preparations that are known or potential inhibitors or inducers of cytochrome P450 enzymes
- Evidence of renal or hepatic dysfunction or any clinically significant deviation from normal during screening including laboratory determinations
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- Known hepatic disease or alcohol abuse
- Any other significant condition that would, in the opinion of the investigator, compromise the volunteer's safety or outcome in the trial
- Current participation in other clinical intervention trial or research protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Pharmacokinetics and Whole Blood Bactericidal Activity Against Mycobacterium Tuberculosis of Single Doses of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers
The purpose of this study is to evaluate the bactericidal activity against Mycobacterium tuberculosis of faropenem boosted with amoxicillin/clavulanic acid. Pharmacokinetics (PK) and Whole blood Bactericidal Activity (WBA) will be measured in healthy volunteers following single doses of faropenem plus amoxicillin/clavulanic acid.
Read the detailed description
WBA is an ex vivo model for measuring the combined effects of administered drugs, host factors and strain factors on mycobacterial killing. If performed in parallel with PK measurements, the method can be used to evaluate the effect of drugs throughout the dosing cycle. The aim of this trial is to investigate the bactericidal activity of faropenem administered with amoxicillin/clavulanic acid (augmentin) using the WBA model. We will also explore whether there is any additive effect or synergy with rifampicin in this model. The activity of faropenem on WBA by different strains of M. tuberculosis will be compared and the relationship between the host immune profile and WBA will be assessed.
- Conditions
- Tuberculosis
- Being tested
- Faropenem, Amoxicillin/clavulanic acid 500mg/125mg, Rifampicin
- Keywords
- Tuberculosis, Whole blood Bactericidal Activity, WBA, Faropenem
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FaropenemDrug
Also called Faropenem sodium
Single oral dose
Amoxicillin/clavulanic acid 500mg/125mgDrug
Also called Augmentin
Single oral dose
RifampicinDrug
Also called Rifampin
Single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Faropenem/augmentin | Experimental | Faropenem 600mg plus amoxicillin/clavulanic acid 500mg/125mg Receives: Drug: Faropenem; Drug: Amoxicillin/clavulanic acid 500mg/125mg |
| Rifampicin/faropenem/augmentin | Experimental | Rifampicin 10mg/kg plus faropenem 600mg plus amoxicillin/clavulanic acid 500mg/125mg Receives: Drug: Faropenem; Drug: Amoxicillin/clavulanic acid 500mg/125mg; Drug: Rifampicin |
| Rifampicin | Experimental | Rifampicin 10mg/kg Receives: Drug: Rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative WBA
Cumulative bactericidal activity (WBA) reported as change in Mtb log CFU per day based on values observed (AUC)
Measured: 8 hours
Secondary outcomes (1)
The pharmacokinetic profile of study drug(s)
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Paton, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393586
- Sponsor's protocol ID
- Faro-WBA
- Status last verified
- Apr 2017
- First submitted
- 6 Mar 2015
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gurumurthy M, Verma R, Naftalin CM, Hee KH, Lu Q, Tan KH, Issac S, Lin W, Tan A, Seng KY, Lee LS, Paton NI. Activity of faropenem with and without rifampicin against Mycobacterium tuberculosis: evaluation in a whole-blood bactericidal activity trial. J Antimicrob Chemother. 2017 Jul 1;72(7):2012-2019. doi: 10.1093/jac/dkx081.
PubMed 28333342
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Pharmacokinetics and Whole Blood Bactericidal Activity Against Mycobacterium Tuberculosis of Single Doses of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02393586
- Acronym / sponsor ID
- Faro-WBA
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Whole blood Bactericidal Activity, WBA, Faropenem
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the bactericidal activity against Mycobacterium tuberculosis of faropenem boosted with amoxicillin/clavulanic acid. Pharmacokinetics (PK) and Whole blood Bactericidal Activity (WBA) will be measured in healthy volunteers following single doses of faropenem plus amoxicillin/clavulanic acid.
Detailed description
WBA is an ex vivo model for measuring the combined effects of administered drugs, host factors and strain factors on mycobacterial killing. If performed in parallel with PK measurements, the method can be used to evaluate the effect of drugs throughout the dosing cycle. The aim of this trial is to investigate the bactericidal activity of faropenem administered with amoxicillin/clavulanic acid (augmentin) using the WBA model. We will also explore whether there is any additive effect or synergy with rifampicin in this model. The activity of faropenem on WBA by different strains of M. tuberculosis will be compared and the relationship between the host immune profile and WBA will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Faropenem/augmentin | Experimental | Drug: Faropenem, Drug: Amoxicillin/clavulanic acid 500mg/125mgFaropenem 600mg plus amoxicillin/clavulanic acid 500mg/125mg |
| Rifampicin/faropenem/augmentin | Experimental | Drug: Faropenem, Drug: Amoxicillin/clavulanic acid 500mg/125mg, Drug: RifampicinRifampicin 10mg/kg plus faropenem 600mg plus amoxicillin/clavulanic acid 500mg/125mg |
| Rifampicin | Experimental | Drug: RifampicinRifampicin 10mg/kg |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 21 and above
- Male or female willing to comply with the study visits and procedures
- Willing and able to provide written informed consent
Key exclusion criteria (9 listed)
- Women who are currently pregnant or breastfeeding
- Signs of active TB
- Previous hypersensitivity or allergy to rifampicin, faropenem or other beta-lactam drugs (penicillins, carbapenems)
- Current use of any drugs or medications known to have an interaction with any of the study drugs
- Current use of any other drugs, over the counter or herbal preparations that are known or potential inhibitors or inducers of cytochrome P450 enzymes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FaropenemAlso: Faropenem sodiumSingle oral dose | Drug | Faropenem/augmentin, Rifampicin/faropenem/augmentin |
| Amoxicillin/clavulanic acid 500mg/125mgAlso: AugmentinSingle oral dose | Drug | Faropenem/augmentin, Rifampicin/faropenem/augmentin |
| RifampicinAlso: RifampinSingle oral dose | Drug | Rifampicin, Rifampicin/faropenem/augmentin |
Primary outcome
Cumulative WBA
Time frame: 8 hours
Cumulative bactericidal activity (WBA) reported as change in Mtb log CFU per day based on values observed (AUC)
1 secondary outcome
The pharmacokinetic profile of study drug(s)
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Derived from this study: PubMed 28333342Gurumurthy M, Verma R, Naftalin CM, Hee KH, Lu Q, Tan KH, Issac S, Lin W, Tan A, Seng KY, Lee LS, Paton NI. Activity of faropenem with and without rifampicin against Mycobacterium tuberculosis: evaluation in a whole-blood bactericidal activity trial. J Antimicrob Chemother. 2017 Jul 1;72(7):2012-2019. doi: 10.1093/jac/dkx081.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Paton principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Faropenem, Amoxicillin/clavulanic acid 500mg/125mg and Rifampicin in people with Tuberculosis, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative WBA (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02393586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.