None listed
Conditions
Interventions
Intervention1: Cefixime SR and Ofloxacin SR: 400mg and 400mg
Control Intervention1: Ofloxacin: 200mg
Sponsors
M/S. Associated Biotech Ltd.
Eligibility
Inclusion criteria
Inclusion criteria:  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.
Exclusion criteria
Exclusion criteria:  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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ? 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). Timepoint: 10 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Timepoint: 10 days | — |
Countries
India
Contacts
Public ContactDr. Nitin M Rathod
Outcome results
None listed