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Trial of faropenem and cefadroxil (in combination with amoxicillin/clavulanic acid and standard TB drugs) in patients with pulmonary tuberculosis

PHRR181108-001980

Faropenem_TB

2018-CT0454

Trial of faropenem and cefadroxil (in combination with amoxicillin/clavulanic acid and standard TB drugs) in patients with pulmonary tuberculosis: measurement of early bactericidal activity and effects on novel biomarkers

A Phase II randomised, controlled, open-label, early bactericidal activity trial

Regime Classification Priority
2017 - 2022 Global competitiveness and innovation in health Drug discovery and development
Start Date Duration in Months Target Completion Date Actual Completion Date
2018-11-30 6 2019-05-30 0000-00-00

Ongoing

Institution Classification Region LTO #
National University Hospital Private Business Singapore N/A
Institution Classification Region LTO #
INC Research Pte. Ltd. Private Business NCR CDRR-NCR-CRO-1
Institution Amount Region
National University Hospital N/A Singapore
Name E-Mail Phone Number Postal Address
Dr. Claire Naftalin claire_naftalin@nuhs.edu.sg +65 6601 5373 Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, 14 Medical Drive, MD6 #15-02T, Singapore 117599
Name E-Mail Phone Number Postal Address
Dr. Claire Naftalin claire_naftalin@nuhs.edu.sg +65 6601 5373 Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, 14 Medical Drive, MD6 #15-02T, Singapore 117599
Name Expertise Affiliation
Vincent M. Balanag, Jr. MD Principal Investigator Lung Center of the Philippines
Marietto Partosa, MD Principal Investigator De La Salle Health Sciences Institute
Thelma Tupasi, MD Principal Investigator Tropical Disease Foundation, Inc.
Project Location Institutional Ethics Review Board
Lung Center of the Philippines Lung Center of the Philippines Ethics Review Committee
De La Salle Health Sciences Institute De La Salle Health Sciences Institute Independent Ethics Committee
Tropical Disease Foundation, Inc. Tropical Disease Foundation Institutional Review Board

Tuberculosis

Rate of change of time to positivity (TTP) in liquid culture from day 0 to day 2

1. Rate of change of TTP in liquid culture from day 0 to day 7
2. Change in CFU/ml in solid culture from Day 0 to Day 2
3. Change in CFU/ml in solid culture from Day 0 to Day 7

Recruiting

  • Philippines
  • Singapore
  • Uganda

Clinical Trial

20180710115454

2018-09-11

None

Inclusion:
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 2-3 day delay in standard therapy
4. Concurrent bacterial pneumonia
5. Known hypersensitivity to beta-lactam drugs (penicillins, carbapenems) or rifampicin
6. History of severe allergies or severe asthma
7. Receiving loop diuretics
8. Estimated creatinine clearance < 80 ml/min on screening blood test.
9. ALT > 2.5 times upper limit of normal on screening blood test.
10. Presence of rifampicin resistance on GeneXpert (or alternative molecular test).
11. Women who are currently pregnant or breastfeeding.
12. Any other significant condition that would, in the opinion of the investigator, compromise the patient’s safety or outcome in the trial.
13. 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.

Interventional

Faropenem and cefadroxil (in combination with amoxicillin/clavulanic acid and standard TB drugs)

Oral administration of:

Arm A: Faropenem 600mg (with amoxicillin/clavulanic acid, 500mg/125mg) given three times daily for 7 days PLUS Rifampicin 10mg/kg once daily alone for the first 2 days then with standard combination therapy (rifampicin, isoniazid, pyrazinamide, ethambutol, adjusted for body weight) for the following 5 days

Arm B: Cefadroxil 1g (with amoxicillin/clavulanic acid, 500mg/125mg) given twice daily for 7 days PLUS Rifampicin 10mg/kg once daily alone for the first 2 days then with standard combination therapy (rifampicin, isoniazid, pyrazinamide, ethambutol, adjusted for body weight) for the following 5 days

Arm C: Rifampicin 10mg/kg once daily alone for the first 2 days then with standard combination therapy (rifampicin, isoniazid, pyrazinamide, ethambutol, adjusted for body weight) for the following 5 days

Randomized

Open Label

Unspecified

Parallel

This trial aims to determine whether the early bactericidal activity of rifampicin given with faropenem or cefadroxil (each given with amoxicillin/clavulanic acid) is greater than the activity of rifampicin alone in patients with pulmonary TB. The trial will also investigate potential new biomarkers of sterilising activity. If successful, this trial could provide sufficient evidence to prompt a clinical development program that may ultimately lead to the adoption of faropenem or cefadroxil as standard TB drugs.

Phase II

45

Unspecified

Unspecified

30 Nov 2018

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