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

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ClinicalTrials.gov Identifier: NCT02393586
Recruitment Status : Completed
First Posted : March 19, 2015
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

Study Description
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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
Tuberculosis Drug: Faropenem Drug: Amoxicillin/clavulanic acid 500mg/125mg Drug: Rifampicin 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
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Study Type : Interventional  (Clinical Trial)
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 : February 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Faropenem/augmentin
Faropenem 600mg plus amoxicillin/clavulanic acid 500mg/125mg
 Drug: Faropenem
Single oral dose
Other Name: Faropenem sodium

Drug: Amoxicillin/clavulanic acid 500mg/125mg
Single oral dose
Other Name: Augmentin
Experimental: Rifampicin/faropenem/augmentin
Rifampicin 10mg/kg plus faropenem 600mg plus amoxicillin/clavulanic acid 500mg/125mg
 Drug: Faropenem
Single oral dose
Other Name: Faropenem sodium

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

Drug: Rifampicin
Single oral dose
Other Name: Rifampin
Experimental: Rifampicin
Rifampicin 10mg/kg
 Drug: Rifampicin
Single oral dose
Other Name: Rifampin


Outcome Measures
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Primary Outcome Measures :
  1. Cumulative WBA [ Time Frame: 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) [ Time Frame: 8 hours ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393586


Locations
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Singapore
National University Hospital
Singapore, Singapore
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
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Principal Investigator: Nicholas Paton National University Hospital, Singapore
More Information
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Study Data/Documents: Link to Pubmed (Final publication)  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT02393586    
Other Study ID Numbers: Faro-WBA
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Keywords provided by National University Hospital, Singapore:
Tuberculosis
Whole blood Bactericidal Activity
WBA
Faropenem
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Amoxicillin
Rifampin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
Clavulanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
 Antitubercular Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
beta-Lactamase Inhibitors