NCT02393586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

8 months

First QC Date

March 6, 2015

Last Update Submit

April 3, 2017

Conditions

Tuberculosis

Keywords

TuberculosisWhole blood Bactericidal ActivityWBAFaropenem

Outcome Measures

Primary Outcomes (1)

  • Cumulative WBA

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

    8 hours

Secondary Outcomes (1)

  • The pharmacokinetic profile of study drug(s)

    8 hours

Study Arms (3)

Faropenem/augmentin

EXPERIMENTAL

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

Drug: FaropenemDrug: Amoxicillin/clavulanic acid 500mg/125mg

Rifampicin/faropenem/augmentin

EXPERIMENTAL

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

Drug: FaropenemDrug: Amoxicillin/clavulanic acid 500mg/125mgDrug: Rifampicin

Rifampicin

EXPERIMENTAL

Rifampicin 10mg/kg

Drug: Rifampicin

Interventions

FaropenemDRUG

Single oral dose

Also known as: Faropenem sodium
Faropenem/augmentinRifampicin/faropenem/augmentin
Amoxicillin/clavulanic acid 500mg/125mgDRUG

Single oral dose

Also known as: Augmentin
Faropenem/augmentinRifampicin/faropenem/augmentin
RifampicinDRUG

Single oral dose

Also known as: Rifampin
RifampicinRifampicin/faropenem/augmentin

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 21 and above
  • Male or female willing to comply with the study visits and procedures
  • Willing and able to provide written informed consent

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

Related Publications (1)

  • 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.

    PMID: 28333342DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

fropenemAmoxicillinClavulanic AcidAmoxicillin-Potassium Clavulanate CombinationRifampin

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsClavulanic AcidsDrug CombinationsPharmaceutical PreparationsRifamycinsHeterocyclic Compounds, 4 or More RingsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Nicholas Paton

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2015

First Posted

March 19, 2015

Study Start

February 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

April 5, 2017

Record last verified: 2017-04

Locations

SG(1)