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Trial record 1 of 10 for:    paton tuberculosis
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Early Bactericidal Activity Study of Faropenem(With Amoxicillin/Clavulanic Acid)in Patients With Pulmonary Tuberculosis

This study is not yet open for participant recruitment.
Verified March 2017 by National University Hospital, Singapore
Sponsor:
ClinicalTrials.gov Identifier:
NCT02381470
First Posted: March 6, 2015
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National University Hospital, Singapore
  Purpose
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.

Condition Intervention Phase
Tuberculosis Drug: Faropenem Drug: Amoxicillin/clavulanic acid Drug: Pyrazinamide Drug: Isoniazid Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Rate of change of time to positivity (TTP) in liquid culture from day 0 to day 5 [ Time Frame: 5 days ]

Secondary Outcome Measures:
  • Rate of change of TTP in liquid culture from day 0 to day 2 [ Time Frame: 2 days ]
  • Change in CFU/ml in solid culture from Day 0 to Day 5 [ Time Frame: 5 days ]
  • Change in CFU/ml in solid culture from Day 0 to Day 2 [ Time Frame: 2 days ]
  • Cumulative bactericidal activity (WBA) at Day 2 [ Time Frame: 2 days ]

Estimated Enrollment: 28
Anticipated Study Start Date: July 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Faropenem+amoxicillin/clavulanic acid
Faropenem 400mg with amoxicillin/clavulanic acid (500mg/125mg) each three times daily for 5 days
Drug: Faropenem
400mg Faropenem
Other Name: Farobact
Drug: Amoxicillin/clavulanic acid
500mg Amoxicillin/ 125mg clavulanic acid
Other Name: Augmentin
Active Comparator: Pyrazinamide
Pyrazinamide 2g (1.5g if weight <50kg) once daily for 5 days
Drug: Pyrazinamide
2g pyrazinamide
Other Name: PZA
Active Comparator: Isoniazid
Isoniazid 300mg once daily for 5 days
Drug: Isoniazid
300mg isoniazid
Other Name: INH

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02381470


Contacts
Contact: Meera Gurumurthy +65 6772 7861 meera@nuhs.edu.sg
Contact: Pang Yan +65 6772 7861 yan_pang@nuhs.edu.sg

Locations
Philippines
Lung Center Philippines Not yet recruiting
Manila, Philippines
Contact: Vincent Balanag         
Principal Investigator: Vincent Balanag         
Philippines Tuberculosis Society (Quezon Institute) Not yet recruiting
Manila, Philippines
Contact: Jubert Benedicto         
Principal Investigator: Jubert Benedicto         
Singapore
Changi General Hospital Not yet recruiting
Singapore, Singapore
Contact: Augustine Tee         
Principal Investigator: Augustine Tee         
National University Hospital, Singapore Not yet recruiting
Singapore, Singapore
Contact: Meera Gurumurthy    +65 6772 7861    meera@nuhs.edu.sg   
Principal Investigator: Nicholas Paton         
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Study Chair: Nicholas Paton National University Hospital, Singapore
  More Information

Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT02381470     History of Changes
Other Study ID Numbers: Faropenem_TB
First Submitted: March 2, 2015
First Posted: March 6, 2015
Last Update Posted: April 4, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Isoniazid
Pyrazinamide
Clavulanic Acids
Clavulanic Acid
beta-Lactams
Anti-Bacterial Agents
Anti-Infective Agents
Antitubercular Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors
beta-Lactamase Inhibitors