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Early Bactericidal Activity Study of Faropenem(With Amoxicillin/Clavulanic Acid)in Patients With Pulmonary Tuberculosis

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 (Drug); Pyrazinamide (Drug); Isoniazid (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: National University Hospital, Singapore

Official(s) and/or principal investigator(s):
Nicholas Paton, Study Chair, Affiliation: National University Hospital, Singapore

Overall contact:
Meera Gurumurthy, Phone: +65 6772 7861, Email: meera@nuhs.edu.sg

Summary

Faropenem is an oral penem, closely related to the carbapenem class that is used for the treatment of bacterial infections. It has in vitro activity against Mycobacterium tuberculosis and this trial aims to determine the activity of faropenem with amoxicillin/clavulanic acid in patients with pulmonary TB.

Clinical Details

Official title: Trial of Faropenem (in Combination With Amoxicillin/Clavulanic Acid) in Patients With Pulmonary Tuberculosis: Measurement of Early Bactericidal Activity, Whole Blood Bactericidal Activity and Effects on Novel Biomarkers

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Rate of change of time to positivity (TTP) in liquid culture from day 0 to day 5

Secondary outcome:

Rate of change of TTP in liquid culture from day 0 to day 2

Change in CFU/ml in solid culture from Day 0 to Day 5

Change in CFU/ml in solid culture from Day 0 to Day 2

Cumulative bactericidal activity (WBA) at Day 2

Detailed description: This is a Phase II randomised, controlled, open-label, early bactericidal activity trial in which 28 patients between the ages of 18 and 70 with newly-diagnosed smear positive pulmonary TB, who have not yet started standard TB therapy will be recruited.

Patients will be randomised to one of 3 arms - Arm A: Faropenem 400mg with

amoxicillin/clavulanic acid (500mg/125mg), each three times daily for 5 days (n=12) Arm B: Pyrazinamide 2g (1. 5g if weight <50kg) once daily for 5 days (n=8) Arm C: Isoniazid 300mg once daily for 5 days (n=8) Following the 5 days of study medication the study will end and patients will change to standard combination TB therapy and enter normal clinical follow-up. In addition to the CFU and TTP related primary and secondary outcome measures, other outcomes measures such as the pharmacokinetics of faropenem, change in RPF-dependent colony counts, change of expression of select signature Mtb genes in sputum transcriptome, changes in host transcriptome and change in host immune profile will be determined.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Aged 18 to 70 years 2. Clinical features compatible with pulmonary TB 3. Sputum smear graded at least 1 + 4. Estimated to be producing at least 5ml of sputum per day 5. Willing to comply with study procedures and able to provide written informed consent. Exclusion Criteria: 1. Suspected miliary TB or TB meningitis 2. Patients receiving any TB treatment within the previous 6 months 3. Patients too ill to tolerate a 5-day delay in standard therapy 4. Concurrent bacterial pneumonia 5. Known hypersensitivity to beta-lactam drugs (penicillins, carbapanems) or to other study drugs (isoniazid, pyrazinamide) 6. Estimated creatinine clearance < 80 ml/min on screening blood test, calculated using Cockcroft-Gault formula 7. ALT > 2. 5 times upper limit of normal on screening blood test. 8. Women who are currently pregnant or breastfeeding. 9. Any other significant condition that would, in the opinion of the investigator, compromise the patient's safety or outcome in the trial. 10. Participation in other clinical intervention trial or research protocol (participation in other studies that do not involve an intervention may be allowed, but this must be discussed and approved by the Chief Investigator)

Locations and Contacts

Meera Gurumurthy, Phone: +65 6772 7861, Email: meera@nuhs.edu.sg

University Malaya Medical Center, Kuala Lumpur, Malaysia; Not yet recruiting
Yong-Kek Pang
Yong-Kek Pang, Principal Investigator

Lung Center Philippines, Manila, Philippines; Not yet recruiting
Vincent Balanag
Vincent Balanag, Principal Investigator

Philippines Tuberculosis Society (Quezon Institute), Manila, Philippines; Not yet recruiting
Violeta Perez
Violeta Perez, Principal Investigator

Changi General Hospital, Singapore, Singapore; Recruiting
Augustine Tee
Augustine Tee, Principal Investigator

National University Hospital, Singapore, Singapore, Singapore; Recruiting
Meera Gurumurthy, Phone: +65 6772 7861, Email: meera@nuhs.edu.sg
Nicholas Paton, Principal Investigator

Additional Information

Starting date: March 2015
Last updated: March 9, 2015

Page last updated: August 23, 2015

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