CTRI/2013/02/003366 [Registered on: 08/02/2013] Trial Registered Prospectively
Last Modified On:
10/06/2014
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Cefozopran injection in treatment of community acquired pneumonia
Scientific Title of Study
Comparative Efficacy, Safety and Tolerability of Inj. Cefozopran Hydrochloride and Inj. Cefpirome Sulphate in the Treatment of Community Acquired Pneumonia - An Open-label Study.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
R2011003
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Monika Obrah
Designation
Project Leader
Affiliation
Ranbaxy Research Laboratories
Address
Group Leader, MACR, Ranbaxy Research Laboratories, Ltd Plot No.77-B, Sector-18, IFFCO Road Gurgaon HARYANA 122015 India
Phone
01244194200
Fax
011244016855
Email
monika.obrah@ranbaxy.com
Details of Contact Person Scientific Query
Name
Shilpa Sharma
Designation
Medical Monitor
Affiliation
Ranbaxy Research Laboratories
Address
SRS, MACR, Ranbaxy Research Laboratories, Ltd Plot No.77-B, Sector-18, IFFCO Road Gurgaon HARYANA 122015 India
Phone
01244194225
Fax
01244016855
Email
shilpa.sharma@ranbaxy.com
Details of Contact Person Public Query
Name
Monika Obrah
Designation
Project Leader
Affiliation
Ranbaxy Research Laboratories
Address
Group Leader, MACR, Ranbaxy Research Laboratories, Ltd Plot No.77-B, Sector-18, IFFCO Road Gurgaon HARYANA 122015 India
Phone
01244194200
Fax
011244016855
Email
monika.obrah@ranbaxy.com
Source of Monetary or Material Support
Ranbaxy Research Laboratories, Plot No.77-B, Sector-18, IFFCO Road, Gurgaon, Haryana
Institutional Ethics Committee, V.M. Medical College and Safdarjung Hospital, New Delhi
Submittted/Under Review
Institutional Ethics Committee, Vasavi Medical and Research Center, Hyderabad
Submittted/Under Review
Medical College Ethics Committee, Kolkata
Submittted/Under Review
osmania medical college ethics committee
Approved
osmania medical college ethics committee
Approved
Penta-Med Ethics Committee, Pune
Approved
Sangini Hospital Ethics Committee, Ahmedabad
Approved
vintage institutional ethics committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Community Acquired Pneumonia,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Cefozopran Injection 1gm
After administration of at least 6 doses of Inj. Cefozopran 1 gm, subjects may be switched to oral antibiotic treatment with Tab. Cefpodoxime. Subjects eligible for oral antibiotic therapy will receive Tab. Cefpodoxime (200 mg, 12 hourly) to complete the remaining days of the 10 day treatment period.
The total duration of study drug therapy (i.v. study drug only or i.v. study drug followed by oral ciprofloxacin) will be 10 days. However, depending upon the clinical condition of the subject, the duration of treatment can be extended to 14 days at the investigator’s discretion.
Comparator Agent
Cefpirome Injection 1gm
After administration of at least 6 doses of Inj. Cefpirome, subjects may be switched to oral antibiotic treatment with Tab. Cefpodoxime. Subjects eligible for oral antibiotic therapy will receive Tab. Cefpodoxime (200 mg, 12 hourly) to complete the remaining days of the 10 day treatment period.
The total duration of study drug therapy (i.v. study drug only or i.v. study drug followed by oral ciprofloxacin) will be 10 days. However, depending upon the clinical condition of the subject, the duration of treatment can be extended to 14 days at the investigator’s discretion.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
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
ExclusionCriteria
Details
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 subject’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
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Clinical Outcome
Test of Cure Assessment (7±2 days post therapy)
Secondary Outcome
Outcome
TimePoints
Microbiological Outcome
Test of Cure Assessment (7±2 days post therapy)
Target Sample Size
Total Sample Size="100" Sample Size from India="100" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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 ‘Test of Cure’ 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.