| CTRI Number |
CTRI/2010/091/002927 [Registered on: 15/11/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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A clinical trial to study the effects of oral tablets of Fixed-dose Combination of Cefpodoxime 200 mg and Ofloxacin 200 mg in Comparison with Cefpodoxime 200 mg alone in patients with respiratory tract infection [RTI] and typhoid fever |
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Scientific Title of Study
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A Multicentric, Open label, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial to Evaluate Efficacy and Safety of oral tablets of Fixed-dose Combination of Cefpodoxime 200 mg and Ofloxacin 200 mg in Comparison with Cefpodoxime 200 mg alone in patients with respiratory tract infection [RTI] and typhoid fever |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| Akums/CT/Cefpo_Oflox/072010 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Dr. Nitin M Rathod |
| Designation |
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| Affiliation |
|
| Address |
R. N. Cooper Hospital, Vileparle west, Mumbai
Mumbai
MAHARASHTRA
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.in |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. Nitin M Rathod |
| Designation |
|
| Affiliation |
|
| Address |
R. N. Cooper Hospital, Vileparle west, Mumbai
Mumbai
MAHARASHTRA
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.in |
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Details of Contact Person
Public Query
|
| Name |
Dr. Nitin M Rathod |
| Designation |
|
| Affiliation |
|
| Address |
R. N. Cooper Hospital, Vileparle west, Mumbai
Mumbai
MAHARASHTRA
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.in |
|
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Source of Monetary or Material Support
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| Akums Drugs & Pharmaceuticals Limited
304, Mohan Place, L.S.C.,
Block C, Saraswati Vihar,
Delhi-110034
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Primary Sponsor
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| Name |
Akums Drugs & Pharmaceuticals Limited |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Rajiv R Oza |
Clinic, Bhavnagar,Rajivoza59@Hotmail.com |
Clinic, Bhavnagar,Rajivoza59@Hotmail.com,-
Bhavnagar
GUJARAT |
Rajivoza59@Hotmail.com |
| Dr. Kirti C Patel |
KEM Hospital, Mumbai, Pkirtic@Yahoo.in |
KEM Hospital, Mumbai, Pkirtic@Yahoo.in,-
Mumbai
MAHARASHTRA |
pkirtic@yahoo.in |
| Dr. Raj G Bhagat |
NHL Medical College & Hospital,Ahmedabad, Rajpurvi@Yahoo.com |
NHL Medical College & Hospital,Ahmedabad, Rajpurvi@Yahoo.com,-
Ahmadabad
GUJARAT |
Rajpurvi@Yahoo.com |
| Dr. Nitin Rathod |
RN Cooper Hospital, Vileparle West, Mumbai, nitinmr@yahoo.in |
RN Cooper Hospital, Vileparle West, Mumbai, nitinmr@yahoo.in,-
Mumbai
MAHARASHTRA |
nitinmr@yahoo.in |
|
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Details of Ethics Committee
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| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Respiratory Tract Infection [RTI] and Typhoid Fever, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Cefpodoxime 200 mg and Ofloxacin 200 mg Tablet |
200mg and 200 mg |
| Comparator Agent |
Cefpodoxime 200 mg tablet |
200mg |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
 All subjects with duly filled and signed in ICFs [Informed Consent Forms]
 Male and female outpatients ³ 18 years of age.
 Clinical diagnosis of respiratory tract infection [RTI] by virtue of following signs & symptoms:
o Fever
o Cough
o Production of sputum
o Leukocytosis
o Radiographic abnormality
 Sputum/ urine culture defining presence of gram-negative and gram-positive bacteria with susceptibility to cefpodoxime and ofloxacin [Culture specimens will be processed in an automatic device (BacT Alert System, Organon Teknika Corp., UK].
 Formerly healthy patients, with functional gastrointestinal tract, and without intestinal complications as perforation or extraintestinal complications like lymphadenitis, arthritis, multifocal osteomyelitis, brain abscesses, pneumonia or sepsis
 If female, using birth control
 Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved Informed Consent Form.
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| ExclusionCriteria |
| Details |
 Patients unwilling to sign on ICF
 Patients with hypersensitivity to cephalosporins or fluoroquinolones
 Patient who severe complications of RTI/ Typhoid fever
 Patients having received antibiotic medication within 14 days prior to dosing
 Patients who test positive for hepatitis B, hepatitis C, HIV or human leucocyte antigen B-27
 An uncontrolled, unstable clinically significant medical condition
 Clinically significant abnormal laboratory, vital sign or ECG findings at screening;
 A positive serum pregnancy test at screening, or the intention to become pregnant within the next 30 days;
 Patient with history of bronchial asthma, bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD) and cystic fibrosis.
 Patient with history of gastritis, hyperacidity, peptic ulcer disease
 Judged by the principal investigator (PI) to be unable to reliably respond to the questionnaire based on clinically significant cognitive impairment
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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On-site computer system |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| The primary objective of this trial is to evaluate any difference between oral tablets of the Fixed-dose Combination of Cefpodoxime 200 mg and Ofloxacin 200 mg with cefpodoxime 200 mg oral tablets in patients with respiratory tract infection [RTI] and typhoid fever in terms of efficacy by virtue of symptomatic improvement during the ten-day study duration |
10 day |
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Secondary Outcome
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| Outcome |
TimePoints |
| The secondary objective of this trial is to evaluate any difference between oral tablets of the Fixed-dose Combination of Cefpodoxime 200 mg and Ofloxacin 200 mg with cefpodoxime 200 mg oral tablets in patients with respiratory tract infection [RTI] and typhoid fever in terms of safety by virtue of comparing adverse events in each arm throughout the trial duration and clinical chemistry profiles at the baseline and end-of-study. |
10 days |
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Target Sample Size
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Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/08/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
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Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This study is A Multicentric, Open label, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial to Evaluate Efficacy and Safety of oral tablets of Fixed-dose Combination of Cefpodoxime 200 mg and Ofloxacin 200 mg in Comparison with Cefpodoxime 200 mg alone in patients with respiratory tract infection [RTI] and typhoid fever that will be conducted in four centres in India |