| CTRI Number |
CTRI/2010/091/000524 [Registered on: 19/07/2010] |
| 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 two drugs,Cefixime SR and Ofloxacin SR 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 SR and Ofloxacin SR in Comparison with Ofloxacin Alone in Patients with Typhoid Fever? |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Associate/Cefoflox/012010 |
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, Mumbai, nitinmr@yahoo.co.in
Mumbai
MAHARASHTRA
400058
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nitin M Rathod |
| Designation |
|
| Affiliation |
|
| Address |
R N Cooper Hospital, Mumbai, nitinmr@yahoo.co.in
Mumbai
MAHARASHTRA
400058
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nitin M Rathod |
| Designation |
|
| Affiliation |
|
| Address |
R N Cooper Hospital, Mumbai, nitinmr@yahoo.co.in
Mumbai
MAHARASHTRA
400058
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| M/S. Associated Biotech Ltd. |
|
|
Primary Sponsor
|
| Name |
M/S. Associated Biotech Ltd. |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
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 |
,-
Bhavnagar
GUJARAT |
|
| Dr. Kirti C Patel |
K E M Hospital, Mumbai, pkirtic@yahoo.co.in |
,-
Mumbai
MAHARASHTRA |
pkirtic@yahoo.co.in |
| Dr. Raj G Bhagat |
N H L Medical College & Hospital, Ahmedabad, Rajpurvi@yahoo.com |
,-
Ahmadabad
GUJARAT |
Rajpurvi@yahoo.com |
| Dr. Nitin M Rathod |
R N Cooper hospital, Mumbai, nitinmr@yahoo.co.in |
,-400057
Mumbai
MAHARASHTRA |
nitinmr@yahoo.co.in |
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Typhoid fever, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cefixime SR and Ofloxacin SR |
400mg and 400mg |
| Comparator Agent |
Ofloxacin |
200mg |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
 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 days |
|
|
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.
|
10 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) |
01/05/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 randomized, open label, parallel group, multi centre trail comparing the safety and efficacy of cefixime SR 400mg and Ofloxacin SR 400mg for 2 months in 200 patients with typhoid fever.that will be conducted in four centres in India |