Health Condition 1: null- community acquired pneumonia (CAP)
Conditions
Interventions
Intervention1: Tigecycline: Tigecycline given as a loading dose of 100 mg followed by a maintenance dose of 50 mg every 12 hours for a period of at least 7 days, unless a clinical failure or a maximum
Sponsors
Glenmark Pharmaceuticals Limited
Eligibility
Inclusion 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 ?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 Hypoxemia (PO2 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Anup Pingle
Asst. Manager- Medical Services
Outcome results
None listed