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Clinical Trials/CTRI/2013/02/003366
CTRI/2013/02/003366
Completed
Phase 3

Comparative Efficacy, Safety and Tolerability of Inj. Cefozopran Hydrochloride and Inj. Cefpirome Sulphate in the Treatment of Community Acquired Pneumonia - An Open-label Study.

Ranbaxy Research Laboratories0 sites100 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Ranbaxy Research Laboratories
Enrollment
100
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Ranbaxy Research Laboratories

Eligibility Criteria

Inclusion Criteria

  • •1\.Subjects who have given written informed consent to participate in this study
  • •2\.Subjects of either sex, aged greater than or equal to 18 years, with diagnosis of community acquired pneumonia requiring hospitalization. The reason for hospitalization will include two or more of the following
  • •a.Elderly (greater than 60 years of age)b.Tachypnoea (respiratory rate greater than or equal to 30 per min)
  • •c.Tachycardia (pulse rate greater than 140 per min)
  • •d.Hypotension (systolic blood pressure less than 90 mm Hg)
  • •e.Hypoxemia (arterial Po2 less than 60 mm Hg while subject is breathing on room air or oxygen saturation less than 90 percent)
  • •f. Acute alteration of mental status
  • •The diagnosis of CAP will be made on the basis of clinical and radiological criteria as given below:
  • •A.Clinical Criteria
  • •A subject should have at least one of the following signs and symptoms

Exclusion Criteria

  • •1\.Subjects with history of hypersensitivity to Cefozopran, Cefpirome, Cefpodoxime or their excipients, penicillins, cephalosporins or other beta\-lactam class of antibiotics.
  • •Excipients of Cefozopran are Sodium carbonate anhydrous and sodium chloride; Cefpirome: Sodium carbonate anhydrous.
  • •Excipients of Cefpodoxime are Carboxymethyl cellulose calcium, hydroxypropylcellulose, sodium lauryl sulphate, lactose, magnesium stearate, FD\&C Yellow No. 6, FD\&C Red No. 40
  • •2\.Subjects who are diagnosed with hospital acquired pneumonia (onset of pneumonia more then or equal to 48 hours after admission to a hospital), atypical pneumonia, viral pneumonia or aspiration pneumonia
  • •3\.Subjects with known bronchial obstruction or a history of post\-obstructive pneumonia.
  • •4\.Subjects with history of allergic bronchitis, hives, rashes, bronchial asthma, bronchiectasis, cystic fibrosis, or lung abscess, known or suspected active pulmonary tuberculosis, primary lung cancer or another malignancy metastatic to lungs.
  • •5\.Subjects on chronic immunosuppressive therapy, including use of high dose corticosteroids (more then or equal to 40 mg prednisolone daily or equivalent), or history of acquired immunodeficiency syndrome (AIDS)
  • •6\.Subjects with history of vitamin K deficiency or conditions predisposing to vitamin K deficiency such as subjects with poor oral intake or on parenteral nutrition or having malabsorption syndrome.
  • •7\.Subjects with adult respiratory distress syndrome (ARDS), meningitis, septic shock, extensive bilateral consolidation, empyema or large pleural effusion or severe CAP requiring ventilator support.
  • •8\.Subjects with abnormal laboratory values at screening: SGOT or AST or SGPT or ALT or alkaline phosphatase or serum bilirubin more then 2 times upper limit of normal or total leukocyte count less then 3500 per mm cube

Outcomes

Primary Outcomes

Not specified

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