?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 SR and Ofloxacin SR in Comparison with Ofloxacin Alone in Patients with Typhoid Fever?

M/S. Associated Biotech Ltd.4 sites in 1 country200 target enrollmentStarted: TBD

Overview

Phase: Phase 3
Sponsor: M/S. Associated Biotech Ltd.
Enrollment: 200
Locations: 4
Primary Endpoint: ?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).

Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Overview

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

Study Design

Allocation: Computer generated randomization
Masking: Open Label

Eligibility 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

•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.

Outcomes

Primary Outcomes

?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).

Time Frame: 10 days

Secondary Outcomes

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)

Investigators

Sponsor

M/S. Associated Biotech Ltd.

Study Sites (4)

Loading locations...

Similar Trials

Unknown

Phase 3

A clinical trial to study the effects of Tapentadol in patients with osteoarthritis & post-operative pain after orthopedic surgery.

CTRI/2010/091/001041M/s. MSN Laboratories Ltd., Hyderabad200

Completed

Phase 3

A clinical trial to study effectiveness and safety of Fixed dose combination tablets of Hyoscine butylbromide & Mefenamic acid in patients suffering from paroxysmal spastic abdominal pain

CTRI/2011/091/000141Cadila Healthcare Ltd200

Recruiting

Phase 3

Garenoxacin Tablets in patients with Community acquired pneumonia

CTRI/2011/10/002055Hetero Labs Ltd200

Completed

Phase 3

A Study of Rebif® Compared With Avonex® in the Treatment of Relapsing-remitting Multiple Sclerosis (MS)Multiple Sclerosis, Relapsing-Remitting

NCT00292266EMD Serono677

Completed

Phase 3

A clinical trial to study the effects of Rituximab injection (Hetero) in Indian patients suffering from varieties of Non-Hodgkins Lymphoma.

CTRI/2013/08/003921Hetero Drugs Limited150