CompletedPhase 2

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

Philippines, Singapore, Uganda58 participantsStarted 2019-02-11

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Aged 18 to 70 years
✓. Clinical features compatible with pulmonary TB
✓. Sputum smear graded at least 1 +
✓. Estimated to be producing at least 5ml of sputum per day
✓. Willing to comply with study procedures and able to provide written informed consent.

Exclusion criteria

✕. Suspected miliary TB or TB meningitis
✕. Patients receiving any TB treatment within the previous 6 months
✕. Patients too ill to tolerate a 2-3 day delay in standard therapy
✕. Concurrent bacterial pneumonia
✕. Known hypersensitivity to beta-lactam drugs (penicillins, carbapenems) or rifampicin
✕. History of severe allergies or severe asthma
✕. Receiving loop diuretics
✕. Estimated creatinine clearance \< 80 ml/min on screening blood test

What they're measuring

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

Timeframe: 2 days

Trial details

NCT IDNCT02381470

SponsorNational University Hospital, Singapore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09-28

View on ClinicalTrials.gov More Pulmonary Tuberculosis trials