Assessment of efficacy, safety and tolerability of tigecycline in adult hospitalized patients with community acquired pneumonia (CAP).

Glenmark Pharmaceuticals Limited0 个研究点目标入组 120 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•?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 >38Â°C/100.4Â°F, axillary temperature >38.1Â°C/100.6Â°F, or a rectal/core temperature >39Â°C/102.2Â°F OR hypothermia (within 24 hours prior to randomization), core temperature <35Â°C/95Â°
•?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

•?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 ≥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.

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