Cefozopran injection in treatment of community acquired pneumonia

Phase 3

Completed

Conditions: Community Acquired Pneumonia

Registration Number: CTRI/2013/02/003366

Lead Sponsor: Ranbaxy Research Laboratories

Brief Summary: This study is a open label, randomized, comparative study with an objective to compare the efficacy, safety and tolerability of Cefozopran inj 1 gm with Cefpirome, to be given twice daily for a period of minimum 3 days ( may be given up to 10 days) for treatment of community acquired pneumonia. The study will be conducted at sites across all geographical locations of India. The lower age limit is 18 years. There is no upper age limit in the protocol approved by DCGI.

The primary objective of the study is to compare the efficacy of intravenous (i.v.) infusion of Cefozopran hydrochloride and Cefpirome sulphate in the treatment of community acquired pneumonia with respect to clinical outcome at *â€˜Test of Cureâ€™* Assessment (7+2 days post therapy). The patients will be hospitalized for a minimum of 3 days. After administration of at least 6 doses of Inj. Cefozopran or Inj Cefpirome, subjects may be switched to oral antibiotic treatment with Tab. Cefpodoxime (200mg, 12 hourly) to complete the remaining days of the 10 days treatment period. The total duration of study drug therapy (i.v. study drug only or i.v. study drug followed by oral Cefpodoxime) will be 10 days. However, depending upen the clinical condition fo the subject, the duration of treatment can be extended to 14 days at the investigator’s discretion.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

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 a.Cough with production of purulent sputum b.Fever, defined as body temperature more then 38 degree C (100.4 degree F)taken orally.
c.Dyspnoea or tachypnoea (respiratory rate more then or equal to 30 per min d.Chest pain e.Clinical findings on chest examination of pulmonary consolidation (dullness on percussion, bronchial breath sounds or egophony)B.Radiological Criteria Chest radiograph should show the presence of new infiltrates in a lobar or multi lobar distribution characteristic of bacterial pneumonia within 48 hours prior to initiation of study treatment.

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 9.Subjects with creatinine clearance of less then or equal to 30 mL per min or those requiring peritoneal dialysis or hemodialysis 10.Subjects who have received antibiotic treatment for more then 24 hrs during the 72 hours prior to enrollment in the study 11.Subjects with significant disease(s) or disorder(s) other than CAP that in the opinion of the investigator may (i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or (iii) cause concern regarding subjectâ€™s ability to participate in the study 12.Pregnant or breast-feeding women or women of child-bearing potential not willing to use medically acceptable methods of contraception or women with positive urine pregnancy test at screening 13.Subjects with a history of substance abuse as per DSM IV criteria 14.Subjects unwilling or unable to comply with the study procedures 15.Subjects who have participated in another investigational study in the previous 3 months prior to entry in this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Outcome	Test of Cure Assessment (7Â±2 days post therapy)

Secondary Outcome Measures

Name	Time	Method
Microbiological Outcome	Test of Cure Assessment (7Â±2 days post therapy)

Trial Locations

Locations (15): Apollo Gleneagles Hospital
🇮🇳
Kolkata, WEST BENGAL, India
Bhatia Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Chandramani Hospital
🇮🇳
Ahmadabad, GUJARAT, India
Ethika Clinical Research Center
🇮🇳
Mumbai, MAHARASHTRA, India
Getwell Hospital and Research Institute
🇮🇳
Nagpur, MAHARASHTRA, India
MV Hospital and Research Centre
🇮🇳
Lucknow, UTTAR PRADESH, India
Nirmal Hospital
🇮🇳
Jhansi, UTTAR PRADESH, India
Orange City Hospital & Research Institute
🇮🇳
Nagpur, MAHARASHTRA, India
Pentagon Research Pvt Ltd
🇮🇳
Pune, MAHARASHTRA, India
Ratandeep Hospital and Research Center
🇮🇳
Dehat, UTTAR PRADESH, India
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Apollo Gleneagles Hospital
🇮🇳Kolkata, WEST BENGAL, India
Dr Shyamasis Bandhyopadyay
Principal investigator
9836576602
sambando@yahoo.co.uk