Overview

This trial is active, not recruiting.

Condition tuberculosis
Treatments faropenem, amoxicillin/clavulanic acid 500mg/125mg, rifampicin
Phase phase 1
Sponsor National University Hospital, Singapore
Start date February 2015
End date May 2016
Trial size 36 participants
Trial identifier NCT02393586, Faro-WBA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Faropenem 600mg plus amoxicillin/clavulanic acid 500mg/125mg
faropenem Faropenem sodium
Single oral dose
amoxicillin/clavulanic acid 500mg/125mg Augmentin
Single oral dose
(Experimental)
Rifampicin 10mg/kg plus faropenem 600mg plus amoxicillin/clavulanic acid 500mg/125mg
faropenem Faropenem sodium
Single oral dose
amoxicillin/clavulanic acid 500mg/125mg Augmentin
Single oral dose
rifampicin Rifampin
Single oral dose
(Experimental)
Rifampicin 10mg/kg
rifampicin Rifampin
Single oral dose

Primary Outcomes

Measure
Cumulative WBA
time frame: 8 hours

Secondary Outcomes

Measure
The pharmacokinetic profile of study drug(s)
time frame: 8 hours

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Evaluating Pharmacokinetics and Whole Blood Bactericidal Activity Against Mycobacterium Tuberculosis of Single Doses of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers
Principal investigator Nicholas Paton
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by National University Hospital, Singapore.