PneumoniaPhase 3PRISM-MDRNCT03409679
Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
A Phase 3 study testing Murepavadin and Two anti-pseudomonal antibiotics in people with Pneumonia, run by Polyphor Ltd. at 61 sites in 13 countries.
Trial summary
This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous murepavadin combined with of one anti-pseudononas antibiotic with that of two anti-pseudomonas antibiotics in the treatment of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Murepavadin and Two anti-pseudomonal antibiotics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 61 sitesin 13 countries
- Study dates
- 23 Mar 2018to 17 Jul 2019
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has received mechanical ventilation for at least 48h at the time of the randomisation
- Acute Physiology and Chronic Health Evaluation (APACHE) of 8 to 30, inclusive, within 24h prior to randomization
- Presence of new or progressive infiltrate on chest X-ray
- Presence of clinical criteria consistent with VABP
- High probability of VABP caused by Pseudomonas aeriginosa
Who cannot join
- Known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia
- Known hypersensitivity or contra-indications to beta-lactam antibiotics, aminoglycosides, quinolones, colistin, or subjects with a clinically significant history of anaphylactic reaction
- Severe liver or renal impairment
- Women who are pregnant or nursing, or who are of chilbearing potential and unwilling to use acceptable method of birth control
Trial locations and contacts
61 sites in 13 countries.
61 sites in 13 countries
France8 sites
Research site
Lille
Reasearch site
Limoges
Research site
Lyon
Reasearch site
Nice
Research site 1
Paris
Research site 2
Paris
Research site 3
Paris
Research site
Pierre-Bénite
South Korea8 sites
Research Site
Ansansi Danweongu
Research Site
Gangwon-do
Research site
Gyeongsang
Research site
Incheon
Research site 1
Seoul
Research site 2
Seoul
Research Site 3
Seoul
Research site
Seoul
Greece6 sites
Research Site
Athens
Research Site
Ioannina
Research Site 1
Larissa
Research Site 2
Larissa
Research Site
Pátrai
Research Site
Thessaloniki
Hungary6 sites
Reasearch site
Budapest, BU
Research site
Budapest, BU
Research Site
Kistarcsa
Reasearch site
Ózd, BZ
Research Site
Székesfehérvár
Research Site
Vác
Israel6 sites
Research site
Jerusalem, JM
Research site
Nahariya, Z
Research site
Petah Tikva
Research site
Safed
Research site
Tel HaShomer
Research site
Tiberias, Z
Brazil5 sites
Research Site 1
Belo Horizonte
Research Site 2
Belo Horizonte
Research Site
Itaquaquecetuba
Research Site
Porto Alegre
Research Site
São José do Rio Preto
South Africa4 sites
Research Site
Cape Town
Research site 1
Pretoria, Gauteng
Research Site 2
Pretoria
Research Site
Pretoria
Thailand4 sites
Research Site 1
Bangkok
Research Site 2
Bangkok
Research Site
Khon Kaen
Research Site
Nonthaburi
United States3 sites
Research site
Chicago, Illinois, 60208
Research site
Greensboro, North Carolina, 27403
Research site
Springfield, Missouri, 65802
Mexico3 sites
Research Site 1
Guadalajara
Research Site 2
Guadalajara
Research Site
Monterrey
Spain3 sites
Research site
Barcelona, B
Research site
Girona
Research site
Terrassa, B
About this study
Official title: A Multicenter, Open-label, Randomized, Active-controlled, Parallel Group, Pivotal Study to Investigate the Efficacy, Safety and Tolerability, and Pharmacokinetics of Murepavadin Combined With One Anti-pseudomonal Antibiotic Versus Two Anti-pseudomonal Antibiotics in Adult Subjects With Ventilator-associated Bacterial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous murepavadin combined with of one anti-pseudononas antibiotic with that of two anti-pseudomonas antibiotics in the treatment of ventilator-associated bacterial pneumonia (VABP) in adult subjects.
- Conditions
- Pneumonia
- Being tested
- Murepavadin, Two anti-pseudomonal antibiotics
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MurepavadinDrug
Murepavadin IV every 8 hours + 1 anti-pseudomonal antibiotic (Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin)
Two anti-pseudomonal antibioticsDrug
Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin
| Study group | Role | What they receive |
|---|---|---|
| Murepavadin | Experimental | Murepavadin IV + one anti-pseudomonal antibiotic Receives: Drug: Murepavadin |
| Two anti-pseudomonal antibiotics | Active comparator | Association of 2 anti-pseudomonal antibiotics Receives: Drug: Two anti-pseudomonal antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate
Measured: 21-24 days after start of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start23 Mar 2018
- Primary completion17 Jul 2019
- Study completion17 Jul 2019
Why it stopped: Safety data review
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polyphor Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409679
- Sponsor's protocol ID
- POL7080-011
- Acronym
- PRISM-MDR
- Status last verified
- May 2019
- First submitted
- 8 Jan 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized, Active-controlled, Parallel Group, Pivotal Study to Investigate the Efficacy, Safety and Tolerability, and Pharmacokinetics of Murepavadin Combined With One Anti-pseudomonal Antibiotic Versus Two Anti-pseudomonal Antibiotics in Adult Subjects With Ventilator-associated Bacterial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
- ClinicalTrials.gov ID
- NCT03409679
- Acronym / sponsor ID
- PRISM-MDR / POL7080-011
- Conditions
- Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety data review
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Polyphor Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 24 Jan 2018 (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.
This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous murepavadin combined with of one anti-pseudononas antibiotic with that of two anti-pseudomonas antibiotics in the treatment of ventilator-associated bacterial pneumonia (VABP) in adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Murepavadin | Experimental | Drug: MurepavadinMurepavadin IV + one anti-pseudomonal antibiotic |
| Two anti-pseudomonal antibiotics | Active comparator | Drug: Two anti-pseudomonal antibioticsAssociation of 2 anti-pseudomonal antibiotics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has received mechanical ventilation for at least 48h at the time of the randomisation
- Acute Physiology and Chronic Health Evaluation (APACHE) of 8 to 30, inclusive, within 24h prior to randomization
- Presence of new or progressive infiltrate on chest X-ray
- Presence of clinical criteria consistent with VABP
- High probability of VABP caused by Pseudomonas aeriginosa
Key exclusion criteria (4 listed)
- Known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia
- Known hypersensitivity or contra-indications to beta-lactam antibiotics, aminoglycosides, quinolones, colistin, or subjects with a clinically significant history of anaphylactic reaction
- Severe liver or renal impairment
- Women who are pregnant or nursing, or who are of chilbearing potential and unwilling to use acceptable method of birth control
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 |
|---|---|---|
| MurepavadinMurepavadin IV every 8 hours + 1 anti-pseudomonal antibiotic (Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin) | Drug | Murepavadin |
| Two anti-pseudomonal antibioticsPiperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin | Drug | Two anti-pseudomonal antibiotics |
Primary outcome
Clinical cure rate
Time frame: 21-24 days after start of study treatment
Results and safety
The study was stopped early (reason given: Safety data review). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Related trials for Pneumonia
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Not yet recruitingPhase 3
Dapagliflozin for Long COVID Syndrome
COVID - 19, Long COVID Syndrome
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
RecruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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.
61 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Murepavadin and Two anti-pseudomonal antibiotics in people with Pneumonia, run by Polyphor Ltd. at 61 sites in 13 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in France, South Korea, Greece, Hungary, Israel and 8 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?
The study was stopped early (reason given: Safety data review). Results are not available in the source record.
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?
Clinical cure rate (time frame: 21-24 days after start of study treatment). 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 28 Aug 2019.