A clinical trial to study the effects of drus, Cefixime and Ofloxacin versus ofloxacin in Patients with Typhoid Fever

Phase 3

• Conditions: Typhoid fever

• Registration Number: CTRI/2010/091/000154
• Lead Sponsor: M/s. Akums Drugs & Pharmaceuticals Ltd.

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

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

• 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.

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 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]?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

Trial Locations

Locations (4)

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

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

R N Cooper Hospital,Vileparle(W), Mumbai, nitinmr@yahoo.in; 🇮🇳 Mumbai, MAHARASHTRA, India

Smt. N H L Muni. medical college, Ahmedabad, Rajpurvi@yahoo.com; 🇮🇳 Ahmadabad, GUJARAT, India

Clinic, Bhavnagar, Rajivoza59@hotmail.com

🇮🇳Bhavnagar, GUJARAT, India

Dr. rajiv R Oza

Principal investigator

Rajivoza59@hotmail.com