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Whole Blood Bactericidal Activity (WBA) Against Mycobacterium Tuberculosis of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers

Sponsor
National University Hospital, Singapore (Other)
Overall Status
Completed
CT.gov ID
NCT02393586
Collaborator
(none)
43
Enrollment
1
Location
3
Arms
8
Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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 amoxicillin/clavulanic acid.

Condition or Disease Intervention/Treatment Phase
Phase 1

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

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluating Pharmacokinetics and Whole Blood Bactericidal Activity Against Mycobacterium Tuberculosis of Single Doses of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Oct 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Faropenem/augmentin

Faropenem 600mg plus amoxicillin/clavulanic acid 500mg/125mg

Drug: Faropenem
Single oral dose
Other Names:
  • Faropenem sodium

    • Drug: Amoxicillin/clavulanic acid 500mg/125mg
    Single oral dose
    Other Names:
  • Augmentin

    		•
    Experimental: Rifampicin/faropenem/augmentin

    Rifampicin 10mg/kg plus faropenem 600mg plus amoxicillin/clavulanic acid 500mg/125mg

    Drug: Faropenem
    Single oral dose
    Other Names:
  • Faropenem sodium

    • Drug: Amoxicillin/clavulanic acid 500mg/125mg
    Single oral dose
    Other Names:
  • Augmentin

    • Drug: Rifampicin
    Single oral dose
    Other Names:
  • Rifampin

    		•
    Experimental: Rifampicin

    Rifampicin 10mg/kg

    Drug: Rifampicin
    Single oral dose
    Other Names:
  • Rifampin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cumulative WBA [8 hours]

      Cumulative bactericidal activity (WBA) reported as change in Mtb log CFU per day based on values observed (AUC)

    Secondary Outcome Measures

    1. The pharmacokinetic profile of study drug(s) [8 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Aged 21 and above

    2. Male or female willing to comply with the study visits and procedures

    3. Willing and able to provide written informed consent

    Exclusion Criteria:

    1. Women who are currently pregnant or breastfeeding

    2. Signs of active TB

    3. Previous hypersensitivity or allergy to rifampicin, faropenem or other beta-lactam drugs (penicillins, carbapenems)

    4. Current use of any drugs or medications known to have an interaction with any of the study drugs

    5. Current use of any other drugs, over the counter or herbal preparations that are known or potential inhibitors or inducers of cytochrome P450 enzymes

    6. Evidence of renal or hepatic dysfunction or any clinically significant deviation from normal during screening including laboratory determinations

    7. Known hepatic disease or alcohol abuse

    8. Any other significant condition that would, in the opinion of the investigator, compromise the volunteer's safety or outcome in the trial

    9. Current participation in other clinical intervention trial or research protocol

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National University Hospital Singapore Singapore

    Sponsors and Collaborators

    • National University Hospital, Singapore

    Investigators

    • Principal Investigator: Nicholas Paton, National University Hospital, Singapore

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National University Hospital, Singapore
    ClinicalTrials.gov Identifier:
    NCT02393586
    Other Study ID Numbers:
    • Faro-WBA
    First Posted:
    Mar 19, 2015
    Last Update Posted:
    Apr 5, 2017
    Last Verified:
    Apr 1, 2017
    Keywords provided by National University Hospital, Singapore
    Tuberculosis
    Whole blood Bactericidal Activity
    WBA
    Faropenem
    Additional relevant MeSH terms:
    Tuberculosis
    Amoxicillin
    Rifampin
    Amoxicillin-Potassium Clavulanate Combination
    Clavulanic Acids
    Clavulanic Acid

    Study Results

    No Results Posted as of Apr 5, 2017