TuberculosisPhase 2TB_COMBO_01NCT04629378
Evaluating the EBA of Meropenem With Amoxicillin/Clavulanate and Pyrazinamide or Bedaquiline in Adults With PTB
A Phase 2 study testing Meropenem Injection, Amoxicillin Clavulanate and Pyrazinamide in people with Tuberculosis, run by TASK Applied Science at 1 site in South Africa.
Trial summary
A single-center, open-label clinical trial to determine the early bactericidal activity (EBA) and safety of the combination of meropenem and amoxicillin/clavulanate plus pyrazinamide vs. meropenem and amoxicillin/clavulanate plus bedaquiline administered for 14 consecutive days. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Meropenem Injection, Amoxicillin Clavulanate and Pyrazinamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Africa
- Study dates
- 17 Aug 2020to 4 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written, informed consent prior to all trial-related procedures including HIV testing.
- Male or female, aged between 18 and 65 years, inclusive.
- Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive.
- Newly diagnosed, previously untreated, rifampicin-susceptible pulmonary TB.
- A chest X-ray picture which in the opinion of the Investigator is consistent with TB.
- Sputum positive on microscopy for acid-fast bacilli on at least one sputum sample (at least 1+ on the IUATLD/WHO scale).
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- Ability to produce an adequate volume of sputum as estimated from an overnight sputum collection sample (estimated 10 ml or more).
- Be of non-childbearing potential or using effective methods of birth control throughout participation in the study until Visit 19 (day 28).
- Non-childbearing potential:
- Female participant/sexual partner - bilateral oophorectomy, bilateral tubal ligation and/or hysterectomy or hasbeen postmenopausal with a history of no menses for at least 12 consecutive months; or
- Male participant/sexual partner - vasectomised or has had a bilateral orchidectomy minimally three month prior to screening;
- Effective birth control methods:
- Participant - not heterosexually active or practicing sexual abstinence; or
- Double barrier method which can include a male condom, diaphragm, cervical cap, or female condom (male and female condoms should not be used together); or
- Barrier method combined with hormone-based contraceptives or an intra-uterine device for the female partner.
Who cannot join
- Evidence of clinically significant conditions or findings, other than the indication being studied, particularly epilepsy, that might compromise safety or the interpretation of trial endpoints, per discretion of the Investigator.
- Poor general condition where any delay in treatment cannot be tolerated per discretion of the Investigator.
- Clinically significant evidence of extrathoracic TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis), as judged by the Investigator.
- Significant history of cardiovascular disease such as heart failure, a personal or family history of congenital QT prolongation, Torsade de Pointes, or QTcF interval > 500 ms (confirmed by repeat electrocardiogram).
- History of allergy to any of the trial IP/s or related substances i.e. β-lactams and penicillin, as confirmed by the clinical judgement of the Investigator.
- Alcohol or drug abuse, that in the opinion of the Investigator, is sufficient to compromise the safety or cooperation of the participant.
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- HIV positive ONLY IF:
- CD4 < 350cells/mm3
- On ART
- Having participated in other clinical studies with investigational agents within 8 weeks prior to trial start.
- Female participant who is pregnant, breast-feeding, or planning to conceive a child within the anticipated period of participating in the trial. Male participant planning to conceive a child within the anticipated period of participating in the trial.
- Subjects with diabetes (Type 1 or 2), or random glucose over 11.1 mmol/L.
- Hypersensitivity to local anaesthesia of amide type.
- Treatment received with any drug active against Mtb (including but not limited to isoniazid, ethambutol, amikacin, cycloserine, fluoroquinolones, rifabutin, rifampicin, streptomycin, kanamycin, para-aminosalicylic acid, rifapentine, pyrazinamide, thioacetazone, capreomycin, thioamides, metronidazole), or with immunosuppressive medications such as TNF-alpha inhibitors or systemic corticosteroids, within 2 weeks prior to screening.
- Participants with the following toxicities at screening as defined by the enhanced CTCEA toxicity table
- creatinine >1.5 times upper limit of normal (ULN);
- haemoglobin <8.0 g/dL;
- platelets equal to or <50x10E9 cells/L);
- serum potassium <3.0 mEq/L;
- aspartate aminotransferase (AST) ≥3.0 x ULN;
- alanine aminotransferase (ALT) ≥3.0 x ULN;
- APTT grade 3
- INR grade 3
- Total white cell count grade 3
Trial locations and contacts
1 site in 1 country.
South Africa1 site
TASK Clinical Research Centre
Cape Town, Western Cape, 7530
About this study
Official title: A Phase 2 Trial to Evaluate the Early Bactericidal Activity and Safety of Meropenem With Amoxicillin/Clavulanate Plus Either Pyrazinamde or Bedaquiline in Adults With Newly Diagnosed Rifampicin-susceptible Pulmonary Tuberculosis
A single-center, open-label clinical trial to determine the early bactericidal activity (EBA) and safety of the combination of meropenem and amoxicillin/clavulanate plus pyrazinamide vs. meropenem and amoxicillin/clavulanate 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.
Read the detailed description
Study design
A single-center, open-label clinical trial. Study treatments include:
- Meropenem 6g intravenously once daily plus amoxicillin/clavulante 2 x 1000mg/62.5mg orally once daily and pyrazinamide 20-30mg/kg orally once daily on days 1-14. Ten participants will be included in this treatment arm.
- Meropenem 6g intravenously once daily plus amoxicillin/clavulanate 2 x 1000mg/62.5mg orally once daily and bedaquiline 400mg orally once daily on days 1-14. Ten participants will be included in this treatment arm.
- 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
- Amoxicillin/CA 1000/62.5mg 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).
- Conditions
- Tuberculosis
- Being tested
- Meropenem Injection, Amoxicillin Clavulanate, Pyrazinamide, Bedaquiline, Rifafour
- Keywords
- tuberculosis, TB, early bactericidal activity
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meropenem InjectionDrug
Meropenem IV 6 grams
Amoxicillin ClavulanateDrug
Amx/CA oral 1000/62.5mg 2 tablets
PyrazinamideDrug
Pyrazinamide 20-30mg/kg
BedaquilineDrug
Bedaquiline 400mg
RifafourDrug
Rifafour (HRZE) Standard dose
| Study group | Role | What they receive |
|---|---|---|
| Meropenem and amoxicillin/clavulanate plus pyrazinamide | Experimental | Meropenem administered intravenously once daily over 6 hours plus amoxicillin/clavulanate 2 x 1000/62.5 mg once daily orally plus pyrazinamide 20-30 mg/kg orally once daily. All study treatments will be administered for 14 consecutive days. Receives: Drug: Meropenem Injection; Drug: Amoxicillin Clavulanate; Drug: Pyrazinamide |
| Meropenem and amoxicillin/clavulanate plus bedaquiline | Experimental | Meropenem administered intravenously once daily over 6 hours plus amoxicillin/clavulanate 2 x 1000/62.5 mg once daily orally plus bedaquiline 400 mg orally once daily. All study treatments will be administered for 14 consecutive days. Receives: Drug: Meropenem Injection; Drug: Amoxicillin Clavulanate; Drug: Bedaquiline |
| Rifafour standard of care treatment | Active comparator | Rifafour e275® administered orally once daily for 14 consecutive days. Rifafour e275® will be administered according to the South African National TB Treatment Guidelines. The daily dose is dependent on the participants' weight as follows: 40 - 54kg: 3 tablets; 55 - 70kg: 4 tablets; 71kg and over: 5 tablets. Receives: Drug: Rifafour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early bactericidal activity (EBA) over 14 treatment days based on the rate of change in colony forming unit (CFU) count per treatment arm
CFU count will be determined from Mycobacterium tuberculosis (M.tb) grown on solid culture. The rate of change in CFU count per ml sputum will be determined from overnight sputum samples collected for at least 2 day before study treatment till day 4 on treatment, followed by alternate days till day 14 on treatment.
Measured: 14 days
Secondary outcomes (6)
EBA over 14 treatment days based on the rate of change in time to positive culture (TTP) per treatment arm
TTP will be determined from M.tb grown in liquid culture media. The rate of change in TTP per ml sputum will be determined from overnight sputum samples collected for at least 2 day before study treatment till day 4 on treatment, followed by alternate days till day 14 on treatment.
Measured: 14 days
Safety and tolerability of study treatments administered over 14 consecutive days
Incidence of treatment emergent adverse events (TEAEs) will be summarised by severity, relatedness to study treatments, and seriousness, leading to early withdrawal and/or leading to death, and summarised per treatment arm.
Measured: 14 days
Cmax: Maximum observed plasma drug concentration.
The maximum observed plasma concentration (Cmax), will be estimated for all analytes in all treatment arm, excluding the standard of care arm. Parameter will be calculated separately using plasma concentrations.
Measured: 14 days
Tmax: Time at which Cmax is observed (obtained without interpolation).(interventional arms only) after 14 consecutive days - Analyte, Meropenem; amoxicillin; CA; bedaquiline
The time to reach Cmax (Tmax), will be estimated for all analytes in all treatment arm, excluding the standard of care arm. Parameter will be calculated separately using plasma concentrations.
Measured: 14 days
Cmin: Minimum observed plasma drug concentration 24 hours following the last dose.
The minimum observed plasma concentration (Cmin) 24 hours following intake of the first daily dosing on day 14, will be estimated for all analytes in all treatment arm, excluding the standard of care arm. Parameter will be calculated separately using plasma concentrations.
Measured: 14 days
AUC(0-24): Area under the drug concentration-time curve calculated using linear trapezoidal summation from time zero to time 24 hours.
The 24 hours following intake of the first daily dosing on day 14, area under the plasma concentration time curve from zero to 24 hours (AUC(0- 24)) will be estimated for all analytes in all treatment arm, excluding the standard of care arm. Parameter will be calculated separately using plasma concentrations.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start17 Aug 2020
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- TASK Applied Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronique R De Jager, MBChB, Principal investigator, TASK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629378
- Sponsor's protocol ID
- TASK-005_TB_COMBO_01
- Acronym
- TB_COMBO_01
- Status last verified
- Nov 2020
- First submitted
- 12 Oct 2020
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Still in planning.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial to Evaluate the Early Bactericidal Activity and Safety of Meropenem With Amoxicillin/Clavulanate Plus Either Pyrazinamde or Bedaquiline in Adults With Newly Diagnosed Rifampicin-susceptible Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT04629378
- Acronym / sponsor ID
- TB_COMBO_01 / TASK-005_TB_COMBO_01
- Conditions
- Tuberculosis
- Keywords
- tuberculosis, TB, early bactericidal activity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- TASK Applied ScienceUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-center, open-label clinical trial to determine the early bactericidal activity (EBA) and safety of the combination of meropenem and amoxicillin/clavulanate plus pyrazinamide vs. meropenem and amoxicillin/clavulanate 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:
- Meropenem 6g intravenously once daily plus amoxicillin/clavulante 2 x 1000mg/62.5mg orally once daily and pyrazinamide 20-30mg/kg orally once daily on days 1-14. Ten participants will be included in this treatment arm.
- Meropenem 6g intravenously once daily plus amoxicillin/clavulanate 2 x 1000mg/62.5mg orally once daily and bedaquiline 400mg orally once daily on days 1-14. Ten participants will be included in this treatment arm.
- 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
- Amoxicillin/CA 1000/62.5mg 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meropenem and amoxicillin/clavulanate plus pyrazinamide | Experimental | Drug: Meropenem Injection, Drug: Amoxicillin Clavulanate, Drug: PyrazinamideMeropenem administered intravenously once daily over 6 hours plus amoxicillin/clavulanate 2 x 1000/62.5 mg once daily orally plus pyrazinamide 20-30 mg/kg orally once daily. All study treatments will be administered for 14 consecutive days. |
| Meropenem and amoxicillin/clavulanate plus bedaquiline | Experimental | Drug: Meropenem Injection, Drug: Amoxicillin Clavulanate, Drug: BedaquilineMeropenem administered intravenously once daily over 6 hours plus amoxicillin/clavulanate 2 x 1000/62.5 mg once daily orally plus bedaquiline 400 mg orally once daily. All study treatments will be administered for 14 consecutive days. |
| Rifafour standard of care treatment | Active comparator | Drug: RifafourRifafour e275® administered orally once daily for 14 consecutive days. Rifafour e275® will be administered according to the South African National TB Treatment Guidelines. The daily dose is dependent on the participants' weight as follows: 40 - 54kg: 3 tablets; 55 - 70kg: 4 tablets; 71kg and over: 5 tablets. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Provide written, informed consent prior to all trial-related procedures including HIV testing.
- Male or female, aged between 18 and 65 years, inclusive.
- Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive.
- Newly diagnosed, previously untreated, rifampicin-susceptible pulmonary TB.
- A chest X-ray picture which in the opinion of the Investigator is consistent with TB.
Key exclusion criteria (24 listed)
- Evidence of clinically significant conditions or findings, other than the indication being studied, particularly epilepsy, that might compromise safety or the interpretation of trial endpoints, per discretion of the Investigator.
- Poor general condition where any delay in treatment cannot be tolerated per discretion of the Investigator.
- Clinically significant evidence of extrathoracic TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis), as judged by the Investigator.
- Significant history of cardiovascular disease such as heart failure, a personal or family history of congenital QT prolongation, Torsade de Pointes, or QTcF interval > 500 ms (confirmed by repeat electrocardiogram).
- History of allergy to any of the trial IP/s or related substances i.e. β-lactams and penicillin, as confirmed by the clinical judgement of the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meropenem InjectionMeropenem IV 6 grams | Drug | Meropenem and amoxicillin/clavulanate plus bedaquiline, Meropenem and amoxicillin/clavulanate plus pyrazinamide |
| Amoxicillin ClavulanateAmx/CA oral 1000/62.5mg 2 tablets | Drug | Meropenem and amoxicillin/clavulanate plus bedaquiline, Meropenem and amoxicillin/clavulanate plus pyrazinamide |
| PyrazinamidePyrazinamide 20-30mg/kg | Drug | Meropenem and amoxicillin/clavulanate plus pyrazinamide |
| BedaquilineBedaquiline 400mg | Drug | Meropenem and amoxicillin/clavulanate plus bedaquiline |
| RifafourRifafour (HRZE) Standard dose | Drug | Rifafour standard of care treatment |
Primary outcome
Early bactericidal activity (EBA) over 14 treatment days based on the rate of change in colony forming unit (CFU) count per treatment arm
Time frame: 14 days
CFU count will be determined from Mycobacterium tuberculosis (M.tb) grown on solid culture. The rate of change in CFU count per ml sputum will be determined from overnight sputum samples collected for at least 2 day before study treatment till day 4 on treatment, followed by alternate days till day 14 on treatment.
6 secondary outcomes
EBA over 14 treatment days based on the rate of change in time to positive culture (TTP) per treatment arm
Time frame: 14 days
Safety and tolerability of study treatments administered over 14 consecutive days
Time frame: 14 days
Cmax: Maximum observed plasma drug concentration.
Time frame: 14 days
Tmax: Time at which Cmax is observed (obtained without interpolation).(interventional arms only) after 14 consecutive days - Analyte, Meropenem; amoxicillin; CA; bedaquiline
Time frame: 14 days
Cmin: Minimum observed plasma drug concentration 24 hours following the last dose.
Time frame: 14 days
AUC(0-24): Area under the drug concentration-time curve calculated using linear trapezoidal summation from time zero to time 24 hours.
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Individual participant dataSharing planned: Yes. Still in planning.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronique R De Jager, MBChB principal investigator
TASK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Meropenem Injection, Amoxicillin Clavulanate and Pyrazinamide in people with Tuberculosis, run by TASK Applied Science at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early bactericidal activity (EBA) over 14 treatment days based on the rate of change in colony forming unit (CFU) count per treatment arm (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.