Study to Evaluate EBA, Safety and Tolerability of Carbapenems in Adults With Pulmonary Tuberculosis

PHASE2CompletedINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

November 9, 2017

Primary Completion Date

January 4, 2021

Study Completion Date

January 4, 2021

Conditions
Pulmonary Tuberculosis
Interventions
DRUG

Meropenem 6g IV over 6 hours

Meropenem 6g intravenously over 6 hours once daily on days 1-14.

DRUG

Ertapenem 1g IM

Ertapenem 1g intramuscularly once daily on days 1-14.

DRUG

Meropenem 3g IV

Meropenem 3g intravenously twice daily over 60 minutes on days 1-14.

DRUG

Ertapenem 1g IV

Ertapenem 1g intravenously once daily on days 1-14.

DRUG

Amoxicillin/CA twice daily

Amoxicillin/CA 2 tablets x 1000mg/62.5mg orally 12-hourly on days 1-14.

DRUG

Rifampicin 35 mg/kg

Rifampicin 35 mg/kg once daily on days 1-14.

DRUG

Meropenem 6g IV over 60 minutes

Meropenem 6g intravenously once daily over 60 minutes on days 1-14.

DRUG

Rifafour e-275

Rifafour e-275 will be supplied as fixed dose combination tablets and administered orally once daily for 14 days as The daily dose is dependent on the participants' weight as follows: 40 - 54kg: 3 tablets; 55 - 70kg: 4 tablets; 71kg and over: 5 tablets.

DRUG

Meropenem 4g IV

Meropenem 4g intravenously once daily over 60 minutes on days 1-14.

DRUG

Amoxicillin/CA once daily

Amoxicillin/CA 2 tablets x 1000mg/62.5mg orally once daily on days 1-14.

Trial Locations (1)

7530

TASK Clinical Research Centre, Cape Town

All Listed Sponsors
lead

TASK Applied Science

OTHER

NCT05896930 - Study to Evaluate EBA, Safety and Tolerability of Carbapenems in Adults With Pulmonary Tuberculosis | Biotech Hunter | Biotech Hunter