Pneumonia, BacterialPhase 2IASISNCT01969799
Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia
A Phase 2 study testing Amikacin fosfomycin inhalation solution in people with Pneumonia, Bacterial, run by Cardeas Pharma at 41 sites in 7 countries.
Trial summary
To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in mechanically ventilated patients receiving IV antibiotics. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pneumonia, Bacterial
- What is being tested?
- Amikacin fosfomycin inhalation solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 41 sitesin 7 countries
- Study dates
- Dec 2013to Apr 2016
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and non-pregnant, non-lactating females, ≥ 18 years and ≤ 80 years of age
- Intubated and mechanically ventilated
- Diagnosis of pneumonia, defined as presence of a new or progressive infiltrate(s) on the most recent chest radiograph prior to screening, as determined by the treating physician
- Signs of infection (within 24 hours prior to screening):
- Fever (> 38ºC or > 100.4ºF); or
- Leukopenia (< 4,000 WBC/mm3) or leukocytosis (≥ 12,000 WBC/mm3)
Show all 10Show fewer
- Impaired oxygenation (within 24 hours prior to screening):
- PaO2/FiO2 ≤ 350 mmHg
- Acute Physiology and Chronic Health Evaluation (APACHE) II score > 10 (within 24 hours prior to screening)
- Presence, or high suspicion, of Gram-negative organism(s) by either Gram stain or culture of respiratory secretions from a sample obtained within the previous 7 days (enrollment can occur before culture results are available)
Who cannot join
- History of hypersensitivity to amikacin, other aminoglycosides, fosfomycin, imipenem, meropenem, or colistin
- Received systemic antibiotic therapy for this episode of Gram-negative pneumonia for greater than 72 hours at the time of randomization
- PaO2/FiO2 ≤ 100 mmHg and diffuse infiltrates on Chest X-ray
- Refractory septic shock (severe sepsis plus unstable hypotension, in spite of adequate fluid resuscitation and vasopressors)
- Any of the following conditions that interfere with the assessment or interpretation of the diagnosis or response to therapy:
- chest trauma with ongoing loss of stability of the thoracic cage following a fracture of the sternum, ribs, or both;
Show all 21Show fewer
- increased amounts of fluid in the lung cavities requiring chest tube drainage;
- lung cancer within the last 2 years;
- lung abscess(s);
- anatomical bronchial obstruction;
- suspected atypical pneumonia;
- chemical pneumonitis (e.g., inhalation injury);
- cystic fibrosis
- Immunocompromised patients, including those with neutropenia NOT due to the current infection (absolute neutrophil count < 500/mm3), leukemia, lymphoma, human immunodeficiency virus (HIV) infection with CD4 count < 200 cells/mm3, or splenectomy; those who are early post-transplantation (< 3 months post-transplant, or > 3 months post-transplant with evidence of organ rejection by clinical criteria, pathologic confirmation, or modification of immunosuppression within the past 4 weeks), are on cytotoxic chemotherapy, or are on high-dose steroids (e.g., > 40 mg of prednisone or its equivalent [> 160 mg hydrocortisone, > 32 mg methylprednisolone, > 6 mg dexamethasone, > 200 mg cortisone] daily for > 2 weeks)
- Evidence of significant renal impairment (serum creatinine > 4.0 mg/dL within 24 hours prior to screening). If serum creatinine is >2.0 mg/dL, site must be capable of performing continuous renal replacement therapy, if clinically indicated. Patients with serum creatinine > 4.0 mg/dL and being treated with continuous renal replacement therapy (continuous venous-venous hemofiltration or continuous venous-venous hemodialysis) or chronic hemodialysis are eligible
- Evidence of ototoxicity (history of hearing aid use prior to current hospitalization)
- Evidence of hepatotoxicity (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3X the upper limit of normal value within 24 hours prior to screening)
- Positive urine and/or serum beta-hCG pregnancy test (only in women of reproductive age)
- On mechanical ventilation for > 28 days
- Glasgow Coma Scale score =3 at Screening
- Participating in or has participated in other investigational interventional studies (drug or device) within the last 30 days (or 5 times the half-life of the previously administered investigational compound, whichever is longer) prior to study treatment
Trial locations and contacts
41 sites in 7 countries.
41 sites in 7 countries
United States16 sites
Study site
Boston, Massachusetts, 02119
Study site
Burlington, Massachusetts, 01805
Study site
Chicago, Illinois, 60612
Study site
Detroit, Michigan, 48202
Study site
El Paso, Texas, 79905
Study site
Gainesville, Florida, 32610
Study site
Hazard, Kentucky, 41701
Study site
Houston, Texas, 77030
Study site
Jacksonville, Florida, 32209
Study site
Knoxville, Tennessee, 37920
Study site
Lexington, Kentucky, 21686
Study site
Los Angeles, California, 90033
Study site
Oklahoma City, Oklahoma, 73104
Study site
Omaha, Nebraska, 60198
Study site
Springfield, Massachusetts, 01199
Study site
St Louis, Missouri, 63110
Greece7 sites
Study site
Alexandroupoli, Evros, 68100
Study site
Athens, 10676
Study site
Athens, 11527
Study site
Athens, 12462
Study site
Athens, 15227
Study site
Ioannina, 45500
Study site
Larissa, 41334
France5 sites
Study site
Colombes, Île-de-France Region, 92701
Study site
Limoges, Limousin, 87042
Study site
Orléans, Loiret, 45000
Study site
Tours, 37044
Study site
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500
Turkey (Türkiye)5 sites
Study site
Ankara, Ankara, 06100
Study site
Ankara, 06110
Study site
Istanbul, 34098
Study site
Istanbul, 34760
Study site
Trabzon, 61080
Hungary4 sites
Study site
Budapest, 1081
Study site
Budapest, 1125
Study site
Debrecen, Hajdú-Bihar, 4012
Study site
Debrecen, Hajdú-Bihar, 4043
Spain3 sites
Study site
Barcelona, 08036
Study site
Getafe, Madrid, 28905
Study site
Palma de Majorca, Balearic Islands, 07010
About this study
Official title: A Randomized Blinded, Placebo-Controlled, Phase 2 Study of Aerosolized Amikacin and Fosfomycin Delivered Via the Investigational eFlow® Inline System in Mechanically Ventilated Patients With Gram-negative Bacterial Pneumonia (IASIS)
To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in mechanically ventilated patients receiving IV antibiotics.
Read the detailed description
The primary purpose of this study is to demonstrate the safety and efficacy of the amikacin fosfomycin inhalation system (AFIS). AFIS consists of amikacin solution and fosfomycin solution, delivered by aerosol to the lungs via the PARI Investigational eFlow Inline System (eFlow Inline System). All patients will receive a standardized course of intravenous (IV) antibiotics for a minimum of 7 days. Patients will be randomized to receive 10 days of treatment with either AFIS or placebo, in addition to the IV therapy. The primary efficacy endpoint is defined as the change from baseline in the Clinical Pulmonary Infection Score (CPIS) during the randomized course of study drug. The study was designed to enroll up to 150 patients with the desire to enroll at least 140 patients with gram negative pneumonia. The study was terminated at 143 when that goal was achieved
- Conditions
- Pneumonia, Bacterial
- Being tested
- Amikacin fosfomycin inhalation solution, Aerosolized placebo
- Keywords
- Gram-negative pneumonia, Aerosol antibiotics, Mechanical ventilation, Amikacin, Fosfomycin, Pneumonia, Bacterial, Pneumonia, Bacterial Infections, Lung Diseases, Respiratory Tract Diseases, Respiratory Tract Infections, Anti-Bacterial Agents, Anti-Infective Agents, Therapeutic Uses, Pharmacologic Actions
- Medical subject headings
- Pneumonia, Bacterial, Pneumonia, Bacterial Infections, Lung Diseases, Respiratory Tract Diseases, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amikacin fosfomycin inhalation solutionDrug
Also called Amikacin fosfomycin inhalation system (AFIS), eFlow Inline System
300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System
Aerosolized placeboDrug
Also called eFlow Inline System
Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System
| Study group | Role | What they receive |
|---|---|---|
| Amikacin fosfomycin inhalation solution | Experimental | 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System. Receives: Drug: Amikacin fosfomycin inhalation solution |
| Aerosolized placebo | Placebo comparator | Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System Receives: Drug: Aerosolized placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Clinical Pulmonary Infection Score (CPIS) For Each Patient, Value Obtained From a Daily Assessment Over the 10 Day Study Period Was Compared to Baseline, and the LSM Data Represent the Change From Baseline Data Over All Days .
Change from baseline in Clinical Pulmonary Infection Score (CPIS) For each patient, value obtained from a daily assessment over the 10 day study period was compared to baseline, and the LSM data represent the change from baseline data over all days. Daily CPIS will be determined by one blinded, central reviewer in order to minimize inter-observer variability. The scale ranges from 0 to 13, with 13 being the worst. The value of zero would be a healthy patient with no evidence of pneumonia. For each patient, there was a daily assessment for the 10 day study period.
Measured: 10 day treatment period.
Secondary outcomes (7)
Composite Endpoint of Mortality and Clinical Cure
The hierarchical composite endpoint of mortality, then clinical cure (defined as both absence of Gram-negative bacteria and CPIS at Day 14 < 6). The tables reflect a winner of matched pairs, ties are not noted.
Measured: Day 1 - Day 28
Composite Endpoint of Mortality and Ventilator-free Days
The hierarchical composite endpoint of mortality, then ventilator-free days. The table reflects winners of matched pairs, ties are not noted.
Measured: Day 1- Day 28
Number of Days Free of Mechanical Ventilation From Day 1 Through Day 28
Number of days free of mechanical ventilation from Day 1 through Day 28 mean days.
Measured: Day 1 - Day 28
Number of ICU Days From Day 1 Through Day 28
Measured: Day 1 - Day 28
Microbiological Response Rates in Patients Positive for Multi-drug Resistant Gram-negative Bacteria
Microbiological response rates at Day 14 in patients whose pre-study treatment bronchoalveolar lavage (BAL) was positive for multi-drug resistant Gram-negative bacteria. Response is defined as not have a positive tracheal aspirate culture on Day 14
Measured: Day 14
Mortality From Day 1 Through Day 28
Mortality from Day 1 through Day 28, all causes, does not reflect just infection only
Measured: Day 1 - Day 28
Clinical Relapse Rate
Clinical relapse rates (defined as a new episode of pneumonia requiring reinstitution of IV antibiotics) from Day 11 through Day 28
Measured: Day 11 - Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2016
- Study completionApr 2016
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 Pneumonia, BacterialStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardeas Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marin Kollef, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969799
- Sponsor's protocol ID
- CAP-01-102
- Other IDs
- 2013-002855-13
- Acronym
- IASIS
- Status last verified
- Mar 2016
- First submitted
- 22 Oct 2013
- Last updated
- 2 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Kollef MH, Ricard JD, Roux D, Francois B, Ischaki E, Rozgonyi Z, Boulain T, Ivanyi Z, Janos G, Garot D, Koura F, Zakynthinos E, Dimopoulos G, Torres A, Danker W, Montgomery AB. A Randomized Trial of the Amikacin Fosfomycin Inhalation System for the Adjunctive Therapy of Gram-Negative Ventilator-Associated Pneumonia: IASIS Trial. Chest. 2017 Jun;151(6):1239-1246. doi: 10.1016/j.chest.2016.11.026. Epub 2016 Nov 24.
PubMed 27890714
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Blinded, Placebo-Controlled, Phase 2 Study of Aerosolized Amikacin and Fosfomycin Delivered Via the Investigational eFlow® Inline System in Mechanically Ventilated Patients With Gram-negative Bacterial Pneumonia (IASIS)
- ClinicalTrials.gov ID
- NCT01969799
- Acronym / sponsor ID
- IASIS / CAP-01-102
- Conditions
- Pneumonia, Bacterial
- Keywords
- Gram-negative pneumonia, Aerosol antibiotics, Mechanical ventilation, Amikacin, Fosfomycin, Pneumonia, Bacterial, Pneumonia, Bacterial Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Cardeas PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Oct 2013 (estimated)
- Results
- Posted 2 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in mechanically ventilated patients receiving IV antibiotics.
Detailed description
The primary purpose of this study is to demonstrate the safety and efficacy of the amikacin fosfomycin inhalation system (AFIS). AFIS consists of amikacin solution and fosfomycin solution, delivered by aerosol to the lungs via the PARI Investigational eFlow Inline System (eFlow Inline System). All patients will receive a standardized course of intravenous (IV) antibiotics for a minimum of 7 days. Patients will be randomized to receive 10 days of treatment with either AFIS or placebo, in addition to the IV therapy. The primary efficacy endpoint is defined as the change from baseline in the Clinical Pulmonary Infection Score (CPIS) during the randomized course of study drug. The study was designed to enroll up to 150 patients with the desire to enroll at least 140 patients with gram negative pneumonia. The study was terminated at 143 when that goal was achieved
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amikacin fosfomycin inhalation solution | Experimental | Drug: Amikacin fosfomycin inhalation solution300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System. |
| Aerosolized placebo | Placebo comparator | Drug: Aerosolized placeboAerosolized placebo twice daily for 10 days administered using the eFlow Inline System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and non-pregnant, non-lactating females, ≥ 18 years and ≤ 80 years of age
- Intubated and mechanically ventilated
- Diagnosis of pneumonia, defined as presence of a new or progressive infiltrate(s) on the most recent chest radiograph prior to screening, as determined by the treating physician
- Signs of infection (within 24 hours prior to screening):
- Impaired oxygenation (within 24 hours prior to screening):
Key exclusion criteria (21 listed)
- History of hypersensitivity to amikacin, other aminoglycosides, fosfomycin, imipenem, meropenem, or colistin
- Received systemic antibiotic therapy for this episode of Gram-negative pneumonia for greater than 72 hours at the time of randomization
- PaO2/FiO2 ≤ 100 mmHg and diffuse infiltrates on Chest X-ray
- Refractory septic shock (severe sepsis plus unstable hypotension, in spite of adequate fluid resuscitation and vasopressors)
- Any of the following conditions that interfere with the assessment or interpretation of the diagnosis or response to therapy:
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 |
|---|---|---|
| Amikacin fosfomycin inhalation solutionAlso: Amikacin fosfomycin inhalation system (AFIS), eFlow Inline System300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System | Drug | Amikacin fosfomycin inhalation solution |
| Aerosolized placeboAlso: eFlow Inline SystemPlacebo twice daily for 10 days to be administered by aerosol the eFlow Inline System | Drug | Aerosolized placebo |
Primary outcome
Change From Baseline in Clinical Pulmonary Infection Score (CPIS) For Each Patient, Value Obtained From a Daily Assessment Over the 10 Day Study Period Was Compared to Baseline, and the LSM Data Represent the Change From Baseline Data Over All Days .
Time frame: 10 day treatment period.
Change from baseline in Clinical Pulmonary Infection Score (CPIS) For each patient, value obtained from a daily assessment over the 10 day study period was compared to baseline, and the LSM data represent the change from baseline data over all days. Daily CPIS will be determined by one blinded, central reviewer in order to minimize inter-observer variability. The scale ranges from 0 to 13, with 13 being the worst. The value of zero would be a healthy patient with no evidence of pneumonia. For each patient, there was a daily assessment for the 10 day study period.
7 secondary outcomes
Composite Endpoint of Mortality and Clinical Cure
Time frame: Day 1 - Day 28
Composite Endpoint of Mortality and Ventilator-free Days
Time frame: Day 1- Day 28
Number of Days Free of Mechanical Ventilation From Day 1 Through Day 28
Time frame: Day 1 - Day 28
Number of ICU Days From Day 1 Through Day 28
Time frame: Day 1 - Day 28
Microbiological Response Rates in Patients Positive for Multi-drug Resistant Gram-negative Bacteria
Time frame: Day 14
Mortality From Day 1 Through Day 28
Time frame: Day 1 - Day 28
Clinical Relapse Rate
Time frame: Day 11 - Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27890714Kollef MH, Ricard JD, Roux D, Francois B, Ischaki E, Rozgonyi Z, Boulain T, Ivanyi Z, Janos G, Garot D, Koura F, Zakynthinos E, Dimopoulos G, Torres A, Danker W, Montgomery AB. A Randomized Trial of the Amikacin Fosfomycin Inhalation System for the Adjunctive Therapy of Gram-Negative Ventilator-Associated Pneumonia: IASIS Trial. Chest. 2017 Jun;151(6):1239-1246. doi: 10.1016/j.chest.2016.11.026. Epub 2016 Nov 24.
- MedlinePlus related topics: AntibioticsLink provided by the sponsor.
- MedlinePlus related topics: PneumoniaLink provided by the sponsor.
- Drug Information available for amikacinLink provided by the sponsor.
- Drug information available for fosfomycinLink provided by the sponsor.
- U.S. FDA ResourcesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Marin Kollef, M.D. principal investigator
Washington University School of Medicine
41 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amikacin fosfomycin inhalation solution in people with Pneumonia, Bacterial, run by Cardeas Pharma at 41 sites in 7 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 10 inclusion and 21 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Greece, France, Turkey (Türkiye), Hungary and 2 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 2 Jul 2017). 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?
Change From Baseline in Clinical Pulmonary Infection Score (CPIS) For Each Patient, Value Obtained From a Daily Assessment Over the 10 Day Study Period Was Compared to Baseline, and the LSM Data Represent the Change From Baseline Data Over All Days . (time frame: 10 day treatment period.). 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 NCT01969799, 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 2 Jul 2017.