CTRI/2010/091/001439
Completed
Phase 4
Assessment of efficacy, safety and tolerability of tigecycline in adult hospitalized patients with community acquired pneumonia (CAP).
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- community acquired pneumonia (CAP)
- Sponsor
- Glenmark Pharmaceuticals Limited
- Enrollment
- 120
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •?Male and female subjects ≥ 18 years of age.
- •?Subjects hospitalized with CAP with PSI 3 and more for whom initial IV antibiotic treatment is indicated for at least 7 days.
- •?The presence of fever (within 24 hours prior to randomization), defined as oral temperature \>38°C/100\.4°F, axillary temperature \>38\.1°C/100\.6°F, or a rectal/core temperature \>39°C/102\.2°F OR hypothermia (within 24 hours prior to randomization), core temperature \<35°C/95°
- •?Each patient must have at least two of the following signs and symptoms consistent with CAP ?
- •Cough with production of purulent or mucopurulent sputum
- •Auscultatory findings on pulmonary examination suggestive of pulmonary consolidation (dullness to percussion, rales/rhonchi, or bronchial breath sounds)
- •Dyspnoea or tachypnoea
- •White blood cell (WBC) count \>10,000/mm3, or \>15% immature neutrophils (bands), and/or leucopoenia with a total WBC count \<4500/mm3
- •Hypoxemia (PO2 \< 60 mm Hg or oxygen saturation \<90% while the subject was breathing room air).
- •Radiologically confirmed evidence of a new or progressive infiltrate( s) consistent with bacterial pneumonia within 48 hours before receiving the first dose of study
Exclusion Criteria
- •?Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed (eg, life expectancy \<30 days)
- •?Hospitalization within 14 days prior to the onset of symptoms
- •?Residence in a long\-term care facility or nursing home \&\#8805;14 days before the onset of symptoms
- •?Sustained shock or required treatment in an intensive care unit
- •?Known or suspected concomitant bacterial infection requiring treatment with an additional systemic antibacterial agent
- •?Received more than one dose of systemic antibacterial therapy (or received a once daily antibiotic) to treat this episode of CAP prior to receiving the first dose of study drug, unless a clinical failure
- •?Known or suspected Pseudomonas, Pneumocystis carinii, Legionella pneumonia, or tuberculosis infection.
- •?Pregnant and lactating woman.
Outcomes
Primary Outcomes
Not specified
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