A clinical trial to assess the efficacy, safety and tolerability of tigecycline in adult hospitalized patients with community acquired pneumonia (CAP).

Phase 4

Completed

Conditions: Health Condition 1: null- community acquired pneumonia (CAP)

Registration Number: CTRI/2010/091/001439

Lead Sponsor: Glenmark Pharmaceuticals Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

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 >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

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 ≥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.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Efficacy Assessment by Pulse oximetry and/or arterial blood gases and Chest x-ray.Timepoint: baseline (within 24 hours of first study dose), during treatment (at day 4), end of therapy (at day 7 till day 14), and test-of-cure (Day 10 to 21 post-therapy).;Clinical Efficacy Assessment by Pulse oximetry and/or arterial blood gases and Chest x-ray.Timepoint: baseline (within 24 hours of first study dose), during treatment (at day 4), end of therapy (at day 7 till day 14), and test-of-cure (Day 10 to 21 post-therapy).

Secondary Outcome Measures