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

• Status: Completed
• Trial end date: 2019-10-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Hospital, Singapore
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; beta-Lactams; Cefadroxil; Clavulanic Acid; Clavulanic Acids; Isoniazid; Pyrazinamide; Rifampin

Criteria

Patient 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.

Patient 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