Whole Blood Bactericidal Activity (WBA) Against Mycobacterium Tuberculosis of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers
Information source: National University Hospital, Singapore
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tuberculosis
Intervention: Faropenem (Drug); Amoxicillin/clavulanic acid 500mg/125mg (Drug); Rifampicin (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: National University Hospital, Singapore Official(s) and/or principal investigator(s): Nicholas Paton, Principal Investigator, Affiliation: National University Hospital, Singapore
Overall contact: Claire Naftalin, Phone: +65 6772 3949, Email: claire_naftalin@nuhs.edu.sg
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Cumulative WBA
Secondary outcome: The pharmacokinetic profile of study drug(s)
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.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Claire Naftalin, Phone: +65 6772 3949, Email: claire_naftalin@nuhs.edu.sg
National University Hospital, Singapore, Singapore; Recruiting Claire Naftalin, Phone: +65 6772 3949, Email: claire_naftalin@nuhs.edu.sg
Additional Information
Starting date: February 2015
Last updated: August 4, 2015
|