A study to investigate whether it is safe and effective to use the new drug murepavadin in patients with pneumonia due to Pseudomonas bacteria
- Conditions
- Health Condition 1: J151- Pneumonia due to Pseudomonas
- Registration Number
- CTRI/2019/04/018855
- Lead Sponsor
- Polyphor Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 286
1. Provide written informed consent prior to any study-related procedure not part of normal
medical care. Surrogate consent/use of a legally-authorized representative may be provided, if permitted by local country and institution-specific guidelines. If a subject regains consciousness while still in the study and, per the investigatorâ??s judgment, the subject is able to read, assess, understand, and make his/her own decision to participate in the trial, the subject can agree to continue study participation and the subject should be re-consented, if required by local country and institution-specific guidelines
2. Male or female subjects, more than 18 years of age
3. Hospitalized for more than 48 hours, intubated (via endo- or nasotracheal tube, including tracheostomy
subjects) and receiving mechanical ventilation for more than 48 hours at the time of randomization, and with acute changes made in the ventilator support system to enhance oxygenation
4. Chest radiograph shows the presence of new or progressive infiltrate(s) characteristic of
bacterial pneumonia (based on Investigatorâ??s evaluation). A chest computerized tomography
(CT) scan may be used in place of a chest X-ray.
5. Clinical findings to support diagnosis of VABP. At least one of the following must be present
within 24 hours prior to randomization:
- Documented fever (oral more than 38.0°C [100.4º F] or a tympanic, temporal, rectal or core temperature more than 38.3º°C [101º F]), or an axillary or forehead scanner more than 37.5° C [99.5° F] OR
- Hypothermia (rectal / core body temperature less than 35º°C [95.2º F]), OR
- Total peripheral white blood cell count (WBC) more than or equal to 10,000 cells/mm3, OR
- Leukopenia with WBC <= 4500 cells/mm3
6. Acute Physiology and Chronic Health Evaluation (APACHE II) score between 8 and 30
inclusive, within 24 hours prior to randomization
7. Strong clinical suspicion that the pneumonia is due to P. aeruginosa. Such evidence could be
the following criteria, but is not limited to:
A surveillance culture from a respiratory sample positive for P. aeruginosa
- A Gram stain performed within 36 hours prior to randomization using an acceptable
respiratory sample (protected brush specimen [PBS], BAL, mini-BAL, ETA (more than equal to 25 PMNs/LPF and less than equal to 10 squamous epithelial cells/LPF), showing Gram-negative rods (with or without
Gram-positive bacteria)
Note:if BAL, mini-BAL, or PBS is available at the site, these modalities are recommended
rather than an ETA for obtaining the baseline lower respiratory tract specimen
- History of P. aeruginosa infection or colonization from a respiratory sample within the last 12 months
A rapid diagnostic test (RDT), performed within 36 hours prior to randomization on respiratory
secretions, may further support the suspicion based on the above clinical criteria
AND
- at least one risk factor, e.g.,
o Broad-spectrum antibiotics (carbapenems, broad-spectrum cephalosporins,
aminoglycosides, fluoroquinolones) administered within 90 days prior to
randomization,
o Current hospitalization of more than or equal 5 days,
o Late onset (more than 4 days after intubation) of VABP,
o History of chronic obstructive pulmonary disease,
o Immunosuppressive
Subjects are not eligible for this trial if they fulfill any of the following exclusion criteria:
1. Known or suspected community-acquired bacterial, viral, fungal, or parasitic pneumonia
2. Any of the following health conditions:
- Confirmed legionella infection (Legionella pneumophila pneumonia), Aspergillus spp.
pneumonia (testing is not required)
- Cystic fibrosis
- Known or suspected Pneumocystis jiroveci pneumonia
- Known or suspected active tuberculosis
- Lung abscess
- Solid organ transplant within 6 months prior to randomization
- Pleural empyema
3. Bronchial obstruction or a history of post-obstructive pneumonia (this does not exclude
subjects with pneumonia who have an underlying chronic obstructive pulmonary disease)
4. Expected survival < 72 hours
5. Current or anticipated neutropenia with absolute neutrophil count (ANC) < 500 cells/mm3
6. Severe renal disease defined as an eGFR-MDRD-6 < 30 mL/min/1.73m2, or requirement for
peritoneal dialysis, hemodialysis, hemofiltration, or a urine output < 20 mL/hour over a 24-hour
period.
7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than or equal to 5 times upper limit of
normal or Child-Pugh B and C in subjects with chronic liver function impairment
8. Received systemic or inhaled antibiotic therapy potentially effective against P. aeruginosa
within 72 hours prior to randomization as follows:
- > 8 i.v. doses of an antibiotic administered q.i.d. (e.g., piperacillin-tazobactam)
- > 6 i.v. doses of an antibiotic administered t.i.d. (e.g., meropenem)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method