A Phase 3 interventional study of Sulbactam and Durlobactam in Acinetobacter Baumannii-calcoaceticus Complex, Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia, sponsored by Entasis Therapeutics. Completed at 92 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-01.
Sponsored by Entasis Therapeutics · Phase 3, Interventional, and Treatment
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.
297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.
This study's enrollment of 207 is above the median of 156 across 156 interventional studies indexed under Bacteremia.
Browse Bacteremia studies →Entasis Therapeutics is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
PART A
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:
PART B
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Sulbactam · Drug: Durlobactam · Drug: Imipenem/Cilastatin 500 mg/500 mg
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.
Drug: Colistin · Drug: Imipenem/Cilastatin 500 mg/500 mg
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.
Drug: Sulbactam · Drug: Durlobactam · Drug: Imipenem/Cilastatin 500 mg/500 mg
1.0 g sulbactam IV infused over 3 hours every 6 hours (q6h).
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.
Also known as: ETX2514
Treatment for 7 days up to 14 days if clinically indicated.
Also known as: COLOMYCIN INJECTION 2 million IU/vial
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.
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.
Time frame: 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.
Time frame: 28 days
| Milestone | Part A - Group 1 | Part A - Group 2 | Part B - Group 3 |
|---|---|---|---|
| Started | 92 | 89 | 26 |
| Completed | 69 | 61 | 20 |
| Not completed | 23 | 28 | 6 |
| Withdrew: Protocol violation | 1 | 0 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 3 | 1 |
| Withdrew: Death | 15 | 21 | 4 |
| Withdrew: No growth of abc | 2 | 1 | 0 |
| Withdrew: Physician decision | 1 | 1 | 1 |
| Withdrew: Prohibited concomitant medication | 1 | 0 | 0 |
| Withdrew: Transferred to other arm/group | 1 | 1 | 0 |
The primary efficacy endpoint for the study is 28-day all-cause mortality in the CRABC m-MITT population in Part A.
| Participants | Part A - Group 1 | Part A - Group 2 |
|---|---|---|
| Proportion of Patients With All-Cause Mortality in CRABC m-MITT Population | 12 | 20 |
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.
| Participants | Part A - Group 1 | Part A - Group 2 |
|---|---|---|
| Proportion of Patients With Nephrotoxicity | 12 | 32 |
Collected over Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A - Group 1 | 25/91 (27.5%) | 36/91 (39.6%) | 48/91 (52.7%) |
| Part A - Group 2 | 31/86 (36%) | 42/86 (48.8%) | 53/86 (61.6%) |
| Part B - Group 3 | 4/28 (14.3%) | 9/28 (32.1%) | 14/28 (50%) |
| Event | Part A - Group 1 | Part A - Group 2 | Part B - Group 3 |
|---|---|---|---|
| Septic shockInfections and infestations | 7/91 | 7/86 | 0/28 |
| Multiple organ dysfunction syndromeGeneral disorders | 1/91 | 4/86 | 2/28 |
| Cardiac arrestCardiac disorders | 2/91 | 4/86 | 1/28 |
| PneumoniaInfections and infestations | 1/91 | 4/86 | 0/28 |
| Shock haemorrhagicVascular disorders | 1/91 | 0/86 | 1/28 |
| Ventricular tachycardiaCardiac disorders | 0/91 | 0/86 | 1/28 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 2/91 | 1/86 | 1/28 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 1/91 | 0/86 | 1/28 |
| NeutropeniaBlood and lymphatic system disorders | 0/91 | 0/86 | 1/28 |
| AscitesGastrointestinal disorders | 0/91 | 0/86 | 1/28 |
| Event | Part A - Group 1 | Part A - Group 2 | Part B - Group 3 |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 15/91 | 9/86 | 2/28 |
| AnaemiaBlood and lymphatic system disorders | 12/91 | 11/86 | 4/28 |
| Decubitus ulcerSkin and subcutaneous tissue disorders | 5/91 | 3/86 | 4/28 |
| HypokalaemiaMetabolism and nutrition disorders | 13/91 | 9/86 | 0/28 |
| Blood creatinine increasedInvestigations | 2/91 | 7/86 | 3/28 |
| Enterococcus test positiveInvestigations | 0/91 | 0/86 | 3/28 |
| Acute kidney injuryRenal and urinary disorders | 3/91 | 9/86 | 0/28 |
| PyrexiaGeneral disorders | 9/91 | 8/86 | 1/28 |
| Urinary tract infectionInfections and infestations | 7/91 | 8/86 | 1/28 |
| Blood alkaline phosphatase increasedInvestigations | 0/91 | 1/86 | 2/28 |
Two (2) participants were transferred from Part A to part B. These participants were analyzed at each arm until/ from the time point of transfer. The number of participants is reported according to the initial Arm/group in which individual participant was assigned.
| Age, Categorical(Participants) | Part A- Group 1 | Part A - Group 2 | Part B - Group 3 | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 43 | 37 | 18 | 98 |
| >=65 years | 49 | 52 | 8 | 109 |
| Age, Continuous(years) | Part A- Group 1 | Part A - Group 2 | Part B - Group 3 | Total |
|---|---|---|---|---|
| Mean | 63.4 ± 15.42 | 66.9 ± 17.13 | 56.2 ± 16.33 | 59.8 ± 16.45 |
| Sex: Female, Male(Participants) | Part A- Group 1 | Part A - Group 2 | Part B - Group 3 | Total |
|---|---|---|---|---|
| Female | 24 | 23 | 5 | 52 |
| Male | 68 | 66 | 21 | 155 |
| Race (NIH/OMB)(Participants) | Part A- Group 1 | Part A - Group 2 | Part B - Group 3 | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 5 | 2 | 0 | 7 |
| Asian | 33 | 44 | 3 | 80 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 1 |
| White | 48 | 41 | 23 | 112 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 6 | 1 | 0 | 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2019 to primary completion in Jul 2021, 22 months.
Results were first posted in Feb 2023, 1 year 6 months after primary completion.
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Studies of the drug tested here: Durlobactam
Entasis Therapeutics