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

April 3, 2017 updated by: National University Hospital, Singapore

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative WBA
Time Frame: 8 hours
Cumulative bactericidal activity (WBA) reported as change in Mtb log CFU per day based on values observed (AUC)
8 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
The pharmacokinetic profile of study drug(s)
Time Frame: 8 hours
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 6, 2015

First Submitted That Met QC Criteria

March 13, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 3, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Faro-WBA

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Link to Pubmed (Final publication)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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