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

Tuberculosis Clinical Trial

Official title:

Evaluating Pharmacokinetics and Whole Blood Bactericidal Activity Against Mycobacterium Tuberculosis of Single Doses of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393586
• Other study ID #: Faro-WBA
• Status: Completed
• Phase: Phase 1
• First received: March 6, 2015
• Last updated: April 3, 2017
• Start date: February 2015
• Est. completion date: October 2015

Study information

• Verified date: April 2017
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mycobacterium Infections
• Tuberculosis

Intervention

Drug:
• Faropenem
Single oral dose
• Amoxicillin/clavulanic acid 500mg/125mg
Single oral dose
• Rifampicin
Single oral dose

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative WBA	Cumulative bactericidal activity (WBA) reported as change in Mtb log CFU per day based on values observed (AUC)	8 hours
Secondary	The pharmacokinetic profile of study drug(s)		8 hours