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CTRI Number  CTRI/2010/091/000154 [Registered on: 13/04/2010]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of drus, Cefixime and Ofloxacin versus ofloxacin in Patients with Typhoid Fever 
Scientific Title of Study   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 Cefixime 200 mg and Ofloxacin 200 mg in Comparison with Ofloxacin 200 mg Alone in Patients with Typhoid Fever 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Akums/Cefoflox/1209A  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Nitin M Rathod 
Designation   
Affiliation   
Address  R N Cooper Hospital,Vileparle(W), Mumbai

Mumbai
MAHARASHTRA
400057
India 
Phone    
Fax    
Email  nitinmr@yahoo.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Nitin M Rathod 
Designation   
Affiliation   
Address  R N Cooper Hospital,Vileparle(W), Mumbai

Mumbai
MAHARASHTRA
400057
India 
Phone    
Fax    
Email  nitinmr@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Dr. Nitin M Rathod 
Designation   
Affiliation   
Address  R N Cooper Hospital,Vileparle(W), Mumbai

Mumbai
MAHARASHTRA
400057
India 
Phone    
Fax    
Email  nitinmr@yahoo.in  
 
Source of Monetary or Material Support  
M/s. Akums Drugs & Pharmaceuticals Ltd. 
 
Primary Sponsor  
Name  M/s. Akums Drugs & Pharmaceuticals Ltd. 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
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  K E M Hospital, Mumbai, pkirtic@yahoo.in  K E M Hospital, Mumbai, pkirtic@yahoo.in,-
Mumbai
MAHARASHTRA 


pkirtic@yahoo.in 
Dr. Nitin M Rathod  R N Cooper Hospital,Vileparle(W), Mumbai, nitinmr@yahoo.in  R N Cooper Hospital,Vileparle(W), Mumbai, nitinmr@yahoo.in,-400057
Mumbai
MAHARASHTRA 


nitinmr@yahoo.in 
Dr. Raj G Bhagat  Smt. N H L Muni. medical college, Ahmedabad, Rajpurvi@yahoo.com  Smt. N H L Muni. medical college, Ahmedabad, Rajpurvi@yahoo.com,-
Ahmadabad
GUJARAT 


Rajpurvi@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
COMSARTs  Approved 
COMSARTs  Approved 
COMSARTs  Approved 
COMSARTs  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Typhoid fever,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cefixime and Ofloxacin  200mg and 200mg respectively, once daily. 
Comparator Agent  Ofloxacin  200mg and 200mg respectively, once daily. 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details   All subjects with duly filled and signed in ICFs [Informed Consent Forms]  Male and female outpatients ³ 18 years of age.  Currently suffering from an typhoid fever characterized by > 100° F for more than three days with malaise, body ache and absence of tachycardia or relative decrease in pulse rate with increased body temperature  Blood culture defining presence of salmonella typhi with susceptibility to cefixime and ofloxacin  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.  
 
ExclusionCriteria 
Details   Patients unwilling to sign on ICF  Patients with hypersensitivity to cephalosporins or fluoroquinolones  Patient who severe complications of typhoid fever  Patients having received antibiotic medication within 14 days prior to dosing  Patients having received typhoid vaccine within 4 weeks 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  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
? Clinical cure (defined as absence of symptoms and signs of infection at day 10 of treatment) and ? Bacteriological cure (defined as a negative culture to S. typhi at day 10 of treatment).   10 day 
 
Secondary Outcome  
Outcome  TimePoints 
? Number of treatment responders and treatment failures [treatment failures defined as fever and symptoms persisting for >7 d after the start of therapy, the development of severe or complicated disease and presence of salmonella in the blood culture done after 7 days] ? Number of paracetamol tablets taken to control the fever during the 10-day study period ? Time when there was no fever for continuous 24 hours without any antipyretic medication received. ? Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC) administered at the completion visit.   7 days 
 
Target Sample Size   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" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  08/02/2010 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years=""
Months="0"
Days="10" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   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 Cefixime 200 mg and Ofloxacin 200 mg in Comparison with Ofloxacin 200 mg Alone in Patients with Typhoid Fever in 200 patients will be conducted in four centres in India 
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