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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02393586
• Date of registration: 06/03/2015
• Prospective Registration: No
• Primary sponsor: National University Hospital, Singapore
• Public title: Whole Blood Bactericidal Activity (WBA) Against Mycobacterium Tuberculosis of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers
• Scientific title: Evaluating Pharmacokinetics and Whole Blood Bactericidal Activity Against Mycobacterium Tuberculosis of Single Doses of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers
• Date of first enrolment: February 2015
• Target sample size: 43
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02393586
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Singapore

Contacts

• Name: Nicholas Paton
• Affiliation: National University Hospital, Singapore

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Tuberculosis

Intervention(s)

Drug: Amoxicillin/clavulanic acid 500mg/125mg

Drug: Faropenem

Drug: Rifampicin

Primary Outcome(s)

Cumulative WBA [Time Frame: 8 hours]

Secondary Outcome(s)

The pharmacokinetic profile of study drug(s) [Time Frame: 8 hours]

Secondary ID(s)

Faro-WBA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors