| 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
|
|
|
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
|
|
|
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 |