Nosocomial and Ventilator-Associated Pneumonia MedDRA version: 9.1 Level: LLT Classification code 10065153 Term: Ventilator associated pneumonia MedDRA version: 9.1 Level: LLT Classification code 10052596 Term: Nosocomial pneumonia
Conditions
Interventions
Trade Name: DORIBAX
Product Name: Doripenem
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Doripenem
CAS Number: 364622-82-2
Current Sponsor code: JNJ-38174942-ZAF (S-4661)
Sponsors
ORTHO MCNEIL JANSSEN SCIENTIFIC AFFAIRS, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Microbiological samples (respiratory secretions) suitable for culture and microscopy (e.g., obtained via BAL, PSB, mini-BAL, deep suction via endotracheal tube [including through a tracheostomy tube], nasotracheal aspiration specimen or suitable expectorated sputum). Note: Suitable specimens from expectorated samples are defined as having /= 25 leukocytes per low power field (10 x objective). If the initial collection of respiratory secretions is obtained via bronchoscope (BAL, PSB) or via mini-BAL (done using a prepackaged, commercially available telescoping catheter, passed through the endotracheal tube), then a sample of respiratory secretions should be obtained simultaneously via deep suctioning through the endotracheal tube or tracheostomy tube. This will allow for a more accurate comparison between a sample obtained at study entry and the required subsequent respiratory samples. 2. CPIS >/= 6 at baseline in subjects with VAP. 3. APACHE II score >/= 8 and /= 5 days of hospitalization or residence in a chronic care facility. Clinical signs and symptoms of pneumonia with AT LEAST 2 of the following criteria: • New onset of purulent sputum production or respiratory secretions or a worsening in character of sputum or respiratory secretions already present. • Tachypnea (respiratory rate >/= 20/minute), particularly if progressive in nature. • De novo hypoxemia with a PO2 /=10,500. Exception: If hospital baseline WBC was significantly above or below 10,500, an increase of at least 25% from the baseline WBC will also constitute leukocytosis. >/= 10% immature neutrophils (bands). • Leukopenia defined as 1°C OR a rectal or oral temperature >38°C, a tympanic temperature >38.4°C OR hypothermia, defined as a rectal/core body temperature of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known or suspected severe renal impairment, (i.e., a calculated creatinine clearance [CrCl] /= 3 times upper limit of the normal range [ULN]). Contact medical monitor if upper limit of normal is >/= 3 times and subject does not have any underlying hepatic disease or disorder. 3. Subjects who have a history of or who are at high risk for seizure disorder or stroke who are not on preventative medication or therapy. 4. Known to be HIV-positive with CD4 counts of 0.2x10(to the power 9) /L [>200 cells/mm3] may be included.) 5. Presence of myelosuppression or neutropenia (ANC <0.5 x 10(to the power 9) /L [<500 PMNs/mm3], unless recovering from chemotherapy and expected to exceed 500 PMNs/mm3 in 24 hours), severe anemia (hemoglobin <6.5 g/dL, not due to acute blood loss) or severe thrombocytopenia (<49.9 x 10(to the power 9) /L) based on CBC results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate clinical response and safety of a new carbapenem in the treatment of subjects with nosocomial pneumonia (NP) or ventilator-associated pneumonia (VAP) in hospitals where Pseudomonas aeruginosa may be a prevalent pathogen.;Secondary Objective: Other objectives are to gain experience with doripenem as part of a combination antibacterial regimen and to collect medical resource utilization data.;Primary end point(s): Clinical response (clinical cure, failure, unable to evaluate), as the primary endpoint, will be assessed at the TOC assessment. Pathogen burden will be tracked and correlated with clinical response. | — |
Countries
France
Outcome results
None listed