A Phase 2, Open-Label, Non-Comparative Study of Doripenem in the Treatment of Nosocomial and Ventilator-Associated Pneumonia in Hospitals where Pseudomonas aeruginosa may be a Prevalent Pathogen.
- Conditions
- osocomial and Ventilator-Associated PneumoniaMedDRA version: 9.1Level: LLTClassification code 10065153Term: Ventilator associated pneumoniaMedDRA version: 9.1Level: LLTClassification code 10052596Term: Nosocomial pneumonia
- Registration Number
- EUCTR2007-005633-10-FR
- Lead Sponsor
- ORTHO MCNEIL JANSSEN SCIENTIFIC AFFAIRS, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
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
4. Subjects suffering from NP or VAP defined as follows:
Nosocomial Pneumonia
(Subjects must have a, b, and c)
a) Clinical signs and symptoms of de novo pneumonia after >/= 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 room air, as determined by arterial blood gas.
b) New radiographic infiltrates (not related to another disease process).
c) Fever or leukocytosis/leukopenia consistent with a diagnosis of
pneumonia with AT LEAST 1 of the following at evaluation:
• Leukocytosis defined as AT LEAST 1 of the following:
Hospital baseline WBC was normal, but subsequently increased to
>/=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 • Fever or documentation of a history of fever ([in the absence of
antipyretics], increase in core temperature of >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 <35°C) within the past
24 hours.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Known or suspected severe renal impairment, (i.e., a calculated
creatinine clearance [CrCl] <10 mL/minute) or oliguria (less than 20
mL urine output per hour over 24 hours unresponsive to fluid
challenge), or requiring peritoneal dialysis, hemodialysis, or
hemofiltration.
2. Known or suspected hepatic dysfunction based on history or previous
laboratory values during hospitalization (total bilirubin, or alanine
aminotransferase [ALT], or aspartate aminotransferase [AST] >/= 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 (entry. (Subjects with HIV and 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>combination antibacterial regimen and to collect medical resource utilization<br>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.
- Secondary Outcome Measures
Name Time Method