Acinetobacter Baumannii-calcoaceticus ComplexPhase 3ATTACKNCT03894046
Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex
A Phase 3 study testing Sulbactam, Durlobactam and Colistin in people with Acinetobacter Baumannii-calcoaceticus Complex and Hospital-acquired Bacterial Pneumonia, run by Entasis Therapeutics at 90 sites in 17 countries.
Trial summary
This is a 2-part study, with Part A being the randomized, controlled portion of the study in patients with ABC hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or bacteremia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acinetobacter Baumannii-calcoaceticus Complex, Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia
- What is being tested?
- Sulbactam, Durlobactam and Colistin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 90 sitesin 17 countries
- Study dates
- 5 Sep 2019to 26 Jul 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PART A
- A confirmed diagnosis of a serious infection that will require treatment with IV antibiotics;
- A known infection caused by ABC (bacteremia, HABP, VABP, VP, cUTI or AP, or surgical or post-traumatic wound infections) as either a single pathogen or member of a polymicrobial infection based on evidence from culture or, if available, rapid diagnostic test from a sample collected within 72 hours prior to randomization (HABP/VABP/VP patients), AND 1 of the following:
- Has received no more than 48 hrs of potentially effective (ie, Gram negative coverage) antimicrobial therapy prior to the first dose of study drug;
- Is clinically failing prior treatment regimens
- APACHE II score 10 and 30 inclusive, or SOFA score between 7 and 11 inclusive, at time of diagnosis
Show all 14Show fewer
- Expectation, in the judgment of the Investigator, that the patient will benefit from effective antibiotic therapy and appropriate supportive care for the anticipated duration of the study
- Women of childbearing potential (ie, not post-menopausal or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test before randomization. Participating women of childbearing potential must be willing to consistently use one highly effective method of contraception (ie, condom, combined oral contraceptive, implant, injectable, indwelling intrauterine device, or a vasectomized partner) from Screening until at least 30 days after administration of the last dose of study drug.
- PART B
- 1. Has an infection (HABP, VABP, VP, bacteremia, cUTI, AP, or surgical or post-traumatic wound infections) caused by ABC organisms known to be resistant to colistin (defined as MIC ≥4 mg/L by a non-agar based method);
- Known to be resistant to colistin or polymyxin B; or
- Known intolerance to colistin; or
- Has myasthenia gravis or another neuromuscular syndrome(s) that contraindicates colistin and is not ventilated; or
- Has acute kidney injury and is receiving renal replacement therapy at study entry.
Who cannot join
- Evidence of active concurrent pneumonia requiring additional antimicrobial treatment
- Presence of suspected or confirmed deep seated bacterial infections such as bacterial Gram negative osteomyelitis, endocarditis, or meningitis requiring prolonged therapy, as determined by history and/or physical examination;
- Sustained shock with persisting hypotension requiring vasopressors to maintain mean arterial pressure (MAP) ≥ 60 mmHg;
- Pregnant or breastfeeding women;
- Receiving peritoneal dialysis;
- Requirement for continuing treatment with probenecid, methotrexate, ganciclovir, valproic acid, or divalproex sodium during the study;
- Evidence of significant hepatic disease or dysfunction, including known acute viral hepatitis, hepatic cirrhosis, hepatic failure, chronic ascites, or hepatic encephalopathy;
Trial locations and contacts
90 sites in 17 countries.
90 sites in 17 countries
China18 sites
Entasis Research Site 1
Beijing
Entasis Research Site 2
Beijing
Entasis Research Site 3
Beijing
Entasis Research Site
Changsha
Entasis Research Site
Chongqing
Entasis Research Site
Guangzhou
Entasis Research Site
Hebei
Entasis Research Site 1
Hefei
Entasis Research Site 2
Hefei
Entasis Research Site
Hubei
Entasis Research Site
Nanchang
Entasis Research Site
Nanjing
Entasis Research Site
Nanning
Entasis Research Site 1
Shanghai
Entasis Research Site 2
Shanghai
Entasis Research Site
Shenzhen
Entasis Research Site
Tianjin
Entasis Research Site
Wuhan
Russia9 sites
Entasis Research Site
Arkhangelsk
Entasis Research Site
Krasnodar
Entasis Research Site 1
Novosibirsk
Entasis Research Site 2
Novosibirsk
Entasis Research Site 3
Novosibirsk
Entasis Research Site 2
Saint Petersburg, 192242
Entasis Research Site
Smolensk
Entasis Research Site 1
Tomsk
Entasis Research Site 2
Tomsk
India7 sites
Entasis Research Site
Ahmedabad
Entasis Research Site
Belagavi
Entasis Research Site 2
Gujrāt, 382 428
Entasis Research Site 1
Gujrāt, 395002
Entasis Research Site
Hyderabad
Entasis Research Site
Kolkata
Entasis Research Site
Pune
Turkey (Türkiye)6 sites
Entasis Research Site 1
Ankara
Entasis Research Site 2
Ankara
Entasis Research Site
Eskişehir
Entasis Research Site
Kocaeli
Entasis Research Site
Küçükçekmece
Entasis Research Site
Trabzon
United States5 sites
Entasis Research Site
Chicago, Illinois, 60611
Entasis Research Site
Cincinnati, Ohio, 45219
Entasis Research Site
Houston, Texas, 77030
Entasis Research Site
Memphis, Tennessee, 38163
Entasis Research Site
Shreveport, Louisiana, 71101
Brazil5 sites
Entasis Research Site
Belo Horizonte
Entasis Research Site
Campinas
Entasis Research Site
Porto Alegre
Entasis Research Site
Salvador
Entasis Research Site
São José do Rio Preto
Greece5 sites
Entasis Research Site 1
Athens
Entasis Research Site 3
Athens
Entasis Research Site
Heraklion
Entasis Research Site
Larissa
Entasis Research Site
Thessaloniki
Mexico5 sites
Entasis Research Site 1
Guadalajara
Entasis Research Site 2
Guadalajara
Entasis Research Site
Mexico City
Entasis Research Site
Monterrey
Entasis Research Site
San Luis Potosí City
Peru5 sites
Entasis Research Site
Bellavista
Entasis Research Site
Cusco
Entasis Research Site
Lima
Entasis Research Site
San Isidro
Entasis Research Site
San Martín de Porres
Belarus4 sites
Entasis Research Site
Brest
Entasis Research Site
Grodno
Entasis Research Site
Homyel
Entasis Research Site
Minsk
Israel4 sites
Entasis Research Site
Holon
Entasis Research Site
Tel Aviv
Entasis Research Site
Tel HaShomer
Entasis Research Site
Tsrifin
Thailand4 sites
Entasis Research Site
Chiang Mai
Entasis Research Site
Khon Kaen
Entasis Research Site
Nakhon Ratchasima
Entasis Research Site
Nonthaburi
Hungary3 sites
Entasis Research Site 1
Budapest
Entasis Research Site 2
Budapest
Entasis Research Site
Debrecen
Lithuania3 sites
Entasis Research Site
Kaunas
Entasis Research Site
Klaipėda
Entasis Research Site
Vilnius
South Korea3 sites
Entasis Research Site
Gyeonggi-do
Entasis Research Site 1
Seoul
Entasis Research Site 2
Seoul
Taiwan3 sites
Entasis Research Site
Kaohsiung City
Entasis Research Site
Taichung
Entasis Research Site
Taipei
About this study
Official title: A Randomized, Active-controlled Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex
This is a 2-part study, with Part A being the randomized, controlled portion of the study in patients with ABC hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or bacteremia. Part B is the single-group portion of the study and includes ABC infections that are resistant to or have failed colistin or polymyxin B treatment, as detailed in the inclusion criteria.
- Conditions
- Acinetobacter Baumannii-calcoaceticus Complex, Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, Bacteremia, Colistin Resistant ABC
- Being tested
- Sulbactam, Durlobactam, Colistin, Imipenem/Cilastatin 500 mg/500 mg
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulbactamDrug
1.0 g sulbactam IV infused over 3 hours every 6 hours (q6h).
DurlobactamDrug
Also called ETX2514
1.0 g durlobactam IV infused over 3 hours every 6 hours (q6h).
Sulbactam-Durlobactam: Treatment for 7 days up to 14 days if clinically indicated.
ColistinDrug
Also called COLOMYCIN INJECTION 2 million IU/vial
Treatment for 7 days up to 14 days if clinically indicated.
Imipenem/Cilastatin 500 mg/500 mgDrug
1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h. Treatment for 7 days up to 14 days if clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Part A - Group 1 | Experimental | Part A was the pivotal, assessor-blind, randomized, comparative portion of the study in patients with documented ABC hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), ventilated pneumonia (VP), or bacteremia.
Part A - Group 1 (experimental): 1.0 g sulbactam/1.0 g durlobactam IV infused over 3 hours every 6 hours (q6h) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h Receives: Drug: Sulbactam; Drug: Durlobactam; Drug: Imipenem/Cilastatin 500 mg/500 mg |
| Part A - Group 2 | Active comparator | Part A - Group 2 (control group): 2.5 mg/kg colistin IV infused over 30 minutes every 12 hours (after an initial loading dose of colistin 2.5 to 5 mg/kg) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h. Receives: Drug: Colistin; Drug: Imipenem/Cilastatin 500 mg/500 mg |
| Part B - Group 3 | Experimental | Part B (Group 3) was the open-label, supportive portion of the study that included patients known to have HABP, VABP, VP, and/or bacteremia infections associated with ABC organisms resistant to colistin or polymyxin B, who failed a colistin or polymyxin B regimen prior to study entry or were on acute renal replacement therapy, and patients with infections due to colistin- or polymyxin B-resistant ABC with sources of infection other than HABP, VABP, VP, and/or bacteremia.
Part B - Group 3: 1.0 g ETX2514/1.0 g sulbactam IV infused over 3 hours q6h plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h. Receives: Drug: Sulbactam; Drug: Durlobactam; Drug: Imipenem/Cilastatin 500 mg/500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With All-Cause Mortality in CRABC m-MITT Population
The primary efficacy endpoint for the study is 28-day all-cause mortality in the CRABC m-MITT population in Part A.
Measured: 28 Days
Proportion of Patients With Nephrotoxicity
The primary safety endpoint for the study is nephrotoxicity, as measured by the Risk-Injury-Failure-Loss-End-stage renal disease (RIFLE) criteria, in the MITT population in Part A.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start5 Sep 2019
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acinetobacter Baumannii-calcoaceticus ComplexStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entasis Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894046
- Sponsor's protocol ID
- CS2514-2017-0004
- Acronym
- ATTACK
- Status last verified
- Jan 2023
- First submitted
- 27 Mar 2019
- Last updated
- 1 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kaye KS, Shorr AF, Wunderink RG, Du B, Poirier GE, Rana K, Miller A, Lewis D, O'Donnell J, Chen L, Reinhart H, Srinivasan S, Isaacs R, Altarac D. Efficacy and safety of sulbactam-durlobactam versus colistin for the treatment of patients with serious infections caused by Acinetobacter baumannii-calcoaceticus complex: a multicentre, randomised, active-controlled, phase 3, non-inferiority clinical trial (ATTACK). Lancet Infect Dis. 2023 Sep;23(9):1072-1084. doi: 10.1016/S1473-3099(23)00184-6. Epub 2023 May 11.
PubMed 37182534
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Active-controlled Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex
- ClinicalTrials.gov ID
- NCT03894046
- Acronym / sponsor ID
- ATTACK / CS2514-2017-0004
- Conditions
- Acinetobacter Baumannii-calcoaceticus Complex, Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, Bacteremia, Colistin Resistant ABC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Entasis TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 28 Mar 2019 (actual)
- Results
- Posted 1 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 2-part study, with Part A being the randomized, controlled portion of the study in patients with ABC hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or bacteremia. Part B is the single-group portion of the study and includes ABC infections that are resistant to or have failed colistin or polymyxin B treatment, as detailed in the inclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A - Group 1 | Experimental | Drug: Sulbactam, Drug: Durlobactam, Drug: Imipenem/Cilastatin 500 mg/500 mgPart A was the pivotal, assessor-blind, randomized, comparative portion of the study in patients with documented ABC hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), ventilated pneumonia (VP), or bacteremia. Part A - Group 1 (experimental): 1.0 g sulbactam/1.0 g durlobactam IV infused over 3 hours every 6 hours (q6h) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h |
| Part A - Group 2 | Active comparator | Drug: Colistin, Drug: Imipenem/Cilastatin 500 mg/500 mgPart A - Group 2 (control group): 2.5 mg/kg colistin IV infused over 30 minutes every 12 hours (after an initial loading dose of colistin 2.5 to 5 mg/kg) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h. |
| Part B - Group 3 | Experimental | Drug: Sulbactam, Drug: Durlobactam, Drug: Imipenem/Cilastatin 500 mg/500 mgPart B (Group 3) was the open-label, supportive portion of the study that included patients known to have HABP, VABP, VP, and/or bacteremia infections associated with ABC organisms resistant to colistin or polymyxin B, who failed a colistin or polymyxin B regimen prior to study entry or were on acute renal replacement therapy, and patients with infections due to colistin- or polymyxin B-resistant ABC with sources of infection other than HABP, VABP, VP, and/or bacteremia. Part B - Group 3: 1.0 g ETX2514/1.0 g sulbactam IV infused over 3 hours q6h plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- PART A
- A confirmed diagnosis of a serious infection that will require treatment with IV antibiotics;
- A known infection caused by ABC (bacteremia, HABP, VABP, VP, cUTI or AP, or surgical or post-traumatic wound infections) as either a single pathogen or member of a polymicrobial infection based on evidence from culture or, if available, rapid diagnostic test from a sample collected within 72 hours prior to randomization (HABP/VABP/VP patients), AND 1 of the following:
- APACHE II score 10 and 30 inclusive, or SOFA score between 7 and 11 inclusive, at time of diagnosis
- Expectation, in the judgment of the Investigator, that the patient will benefit from effective antibiotic therapy and appropriate supportive care for the anticipated duration of the study
Key exclusion criteria (7 listed)
- Evidence of active concurrent pneumonia requiring additional antimicrobial treatment
- Presence of suspected or confirmed deep seated bacterial infections such as bacterial Gram negative osteomyelitis, endocarditis, or meningitis requiring prolonged therapy, as determined by history and/or physical examination;
- Sustained shock with persisting hypotension requiring vasopressors to maintain mean arterial pressure (MAP) ≥ 60 mmHg;
- Pregnant or breastfeeding women;
- Receiving peritoneal dialysis;
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 |
|---|---|---|
| Sulbactam1.0 g sulbactam IV infused over 3 hours every 6 hours (q6h). | Drug | Part A - Group 1, Part B - Group 3 |
| DurlobactamAlso: ETX25141.0 g durlobactam IV infused over 3 hours every 6 hours (q6h). Sulbactam-Durlobactam: Treatment for 7 days up to 14 days if clinically indicated. | Drug | Part A - Group 1, Part B - Group 3 |
| ColistinAlso: COLOMYCIN INJECTION 2 million IU/vialTreatment for 7 days up to 14 days if clinically indicated. | Drug | Part A - Group 2 |
| Imipenem/Cilastatin 500 mg/500 mg1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h. Treatment for 7 days up to 14 days if clinically indicated. | Drug | Part A - Group 1, Part A - Group 2, Part B - Group 3 |
Primary outcome
Proportion of Patients With All-Cause Mortality in CRABC m-MITT Population
Time frame: 28 Days
The primary efficacy endpoint for the study is 28-day all-cause mortality in the CRABC m-MITT population in Part A.
Proportion of Patients With Nephrotoxicity
Time frame: 28 days
The primary safety endpoint for the study is nephrotoxicity, as measured by the Risk-Injury-Failure-Loss-End-stage renal disease (RIFLE) criteria, in the MITT population in Part A.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37182534Kaye KS, Shorr AF, Wunderink RG, Du B, Poirier GE, Rana K, Miller A, Lewis D, O'Donnell J, Chen L, Reinhart H, Srinivasan S, Isaacs R, Altarac D. Efficacy and safety of sulbactam-durlobactam versus colistin for the treatment of patients with serious infections caused by Acinetobacter baumannii-calcoaceticus complex: a multicentre, randomised, active-controlled, phase 3, non-inferiority clinical trial (ATTACK). Lancet Infect Dis. 2023 Sep;23(9):1072-1084. doi: 10.1016/S1473-3099(23)00184-6. Epub 2023 May 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
90 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sulbactam, Durlobactam and Colistin in people with Acinetobacter Baumannii-calcoaceticus Complex and Hospital-acquired Bacterial Pneumonia, run by Entasis Therapeutics at 90 sites in 17 countries.
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 14 inclusion and 7 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 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 90 sites in China, Russia, India, Turkey (Türkiye), United States and 12 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Patients With All-Cause Mortality in CRABC m-MITT Population (time frame: 28 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03894046, which also lists 1 linked publication.
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 1 Feb 2023.