Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04629378
Status:
COMPLETED
Last Update Posted:
2022-01-25
First Post:
2020-10-12
Brief Title:
Evaluating the EBA of Meropenem With AmoxicillinClavulanate and Pyrazinamide or Bedaquiline in Adults With PTB
Sponsor:
TASK Applied Science
Organization:
TASK Applied Science
Study Overview
Official Title:
A Phase 2 Trial to Evaluate the Early Bactericidal Activity and Safety of Meropenem With AmoxicillinClavulanate Plus Either Pyrazinamde or Bedaquiline in Adults With Newly Diagnosed Rifampicin-susceptible Pulmonary Tuberculosis
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TB_COMBO_01
Brief Summary:
A single-center open-label clinical trial to determine the early bactericidal activity EBA and safety of the combination of meropenem and amoxicillinclavulanate plus pyrazinamide vs meropenem and amoxicillinclavulanate plus bedaquiline administered for 14 consecutive days This study forms part of a series of 2-week EBA studies to determine the relative bactericidal activity of several new or repurposed anti-tuberculosis agents from which to determine the most effective and safe combination to evaluate in larger and longer duration regimen-based trials
Detailed Description:
Study design
A single-center open-label clinical trial Study treatments include
1 Meropenem 6g intravenously once daily plus amoxicillinclavulante 2 x 1000mg625mg orally once daily and pyrazinamide 20-30mgkg orally once daily on days 1-14 Ten participants will be included in this treatment arm
2 Meropenem 6g intravenously once daily plus amoxicillinclavulanate 2 x 1000mg625mg orally once daily and bedaquiline 400mg orally once daily on days 1-14 Ten participants will be included in this treatment arm
3 Rifafour e- 275 HRZE orally once daily on days 1-14 with weight-banded dosing Two participants will receive standard first line TB treatment as per the South African TB guidelines Rifafour e- 275 and is included as a control for the EBA quantitative mycobacteriology and to evaluate whether HRZE gives similar EBA results to that demonstrated in prior studies with this combination
Patient Population
A total of 22 male and female participants aged between 18 and 65 years inclusive with newly diagnosed smear-positive pulmonary TB will be included
Treatment
The Investigational Product IP will be supplied as
Meropenem 1g reconstitution vials
AmoxicillinCA 1000625mg tablets
Pyrazinamide 500mg tablets
Bedaquiline 100mg tablets
Statistical Methods
This is a descriptive study with no inferential statistics or hypothesis testing The planned sample size of 10 participants per treatment group is in keeping with other phase 2 trials of this type and accounts for the possibility of up to 3 drop-outs per arm which based on previous studies of this type conducted at these sites represents a conservative estimate of the expected drop-out rate
Trial Duration
37 days up to 9 days pre-treatment plus 15 days treatment period plus 14 days post- treatment follow- up
A single-center open-label clinical trial Study treatments include
1 Meropenem 6g intravenously once daily plus amoxicillinclavulante 2 x 1000mg625mg orally once daily and pyrazinamide 20-30mgkg orally once daily on days 1-14 Ten participants will be included in this treatment arm
2 Meropenem 6g intravenously once daily plus amoxicillinclavulanate 2 x 1000mg625mg orally once daily and bedaquiline 400mg orally once daily on days 1-14 Ten participants will be included in this treatment arm
3 Rifafour e- 275 HRZE orally once daily on days 1-14 with weight-banded dosing Two participants will receive standard first line TB treatment as per the South African TB guidelines Rifafour e- 275 and is included as a control for the EBA quantitative mycobacteriology and to evaluate whether HRZE gives similar EBA results to that demonstrated in prior studies with this combination
Patient Population
A total of 22 male and female participants aged between 18 and 65 years inclusive with newly diagnosed smear-positive pulmonary TB will be included
Treatment
The Investigational Product IP will be supplied as
Meropenem 1g reconstitution vials
AmoxicillinCA 1000625mg tablets
Pyrazinamide 500mg tablets
Bedaquiline 100mg tablets
Statistical Methods
This is a descriptive study with no inferential statistics or hypothesis testing The planned sample size of 10 participants per treatment group is in keeping with other phase 2 trials of this type and accounts for the possibility of up to 3 drop-outs per arm which based on previous studies of this type conducted at these sites represents a conservative estimate of the expected drop-out rate
Trial Duration
37 days up to 9 days pre-treatment plus 15 days treatment period plus 14 days post- treatment follow- up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None