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

Summary

The goal of this single-center, open-labelled, clinical trial in two groups aims to proof that a specific group of antibiotics (carbapenems) can be used to treat pulmonary tuberculosis if it is combined with another antibiotic (amoxicillin/clavulanate). A total of 113 male or female participants (8 groups and 9 treatment regimens as group 8 was split into 2 groups of 4 participants receiving Rifafour e-275), aged between 18 and 65 years (inclusive), with newly diagnosed, smear-positive, pulmonary TB.

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.

Sponsors & Collaborators

• TASK Applied Science

  lead OTHER

Principal Investigators

• Prof Andreas H Diacon, MD, PhD · TASK

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-09

Primary Completion

2021-01-04

Completion

2021-01-04

Countries

• South Africa

Study Locations