A clinical trial to study the effects of drus, Cefixime and Ofloxacin versus ofloxacin in Patients with Typhoid Fever
- Registration Number
- CTRI/2010/091/000154
- Lead Sponsor
- M/s. Akums Drugs & Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ?Clinical cure (defined as absence of symptoms and signs of infection at day 10 of treatment) and <br>?Bacteriological cure (defined as a negative culture to S. typhi at day 10 of treatment).<br>Timepoint: 10 day
- Secondary Outcome Measures
Name Time Method ?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]<br>?Number of paracetamol tablets taken to control the fever during the 10-day study period<br>?Time when there was no fever for continuous 24 hours without any antipyretic medication received.<br>?Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC) administered at the completion visit.<br>Timepoint: 7 days