Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE March 6, 2015
First Posted Date  ICMJE March 19, 2015
Last Update Posted Date April 5, 2017
Study Start Date  ICMJE February 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2015)
Cumulative WBA [ Time Frame: 8 hours ]
Cumulative bactericidal activity (WBA) reported as change in Mtb log CFU per day based on values observed (AUC)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02393586 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2015)
The pharmacokinetic profile of study drug(s) [ Time Frame: 8 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2015)
  • The pharmacokinetic profile of study drug(s) [ Time Frame: 8 hours ]
  • WBA dose response across the faropenem groups [ Time Frame: 8 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Whole Blood Bactericidal Activity (WBA) Against Mycobacterium Tuberculosis of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers
Official Title  ICMJE Evaluating Pharmacokinetics and Whole Blood Bactericidal Activity Against Mycobacterium Tuberculosis of Single Doses of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tuberculosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Faropenem/augmentin
    Faropenem 600mg plus amoxicillin/clavulanic acid 500mg/125mg
    Interventions:
    • Drug: Faropenem
    • Drug: Amoxicillin/clavulanic acid 500mg/125mg
  • Experimental: Rifampicin/faropenem/augmentin
    Rifampicin 10mg/kg plus faropenem 600mg plus amoxicillin/clavulanic acid 500mg/125mg
    Interventions:
    • Drug: Faropenem
    • Drug: Amoxicillin/clavulanic acid 500mg/125mg
    • Drug: Rifampicin
  • Experimental: Rifampicin
    Rifampicin 10mg/kg
    Intervention: Drug: Rifampicin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2017)
43
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2015)
24
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02393586
Other Study ID Numbers  ICMJE Faro-WBA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National University Hospital, Singapore
Study Sponsor  ICMJE National University Hospital, Singapore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicholas Paton National University Hospital, Singapore
PRS Account National University Hospital, Singapore
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP