A clinical trial to study the effects of two drugs,Cefixime SR and Ofloxacin SR in Patients with Typhoid Fever

Phase 3

• Conditions: Typhoid fever

• Registration Number: CTRI/2010/091/000524
• Lead Sponsor: M/S. Associated Biotech Ltd.

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

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 200

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

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: Not specified
• 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 ?Bacteriological cure (defined as a negative culture to S. typhi at day 10 of treatment).	10 days

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] ? 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

Trial Locations

Locations (4)

Clinic, Bhavnagar, Rajivoza59@hotmail.com; 🇮🇳 Bhavnagar, GUJARAT, India

K E M Hospital, Mumbai, pkirtic@yahoo.co.in; 🇮🇳 Mumbai, MAHARASHTRA, India

N H L Medical College & Hospital, Ahmedabad, Rajpurvi@yahoo.com; 🇮🇳 Ahmadabad, GUJARAT, India

R N Cooper hospital, Mumbai, nitinmr@yahoo.co.in; 🇮🇳 Mumbai, MAHARASHTRA, India

Clinic, Bhavnagar, Rajivoza59@hotmail.com

🇮🇳Bhavnagar, GUJARAT, India

Dr. Rajiv R Oza

Principal investigator