Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

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Brief Title

Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

Official Title

Randomized, Open-label, Superiority Trial of the Effectiveness of Gatifloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Enteric Fever.

Brief Summary

      The investigators aim to compare two antibiotic treatments for enteric (typhoid) fever. Three
      hundred patients at Patan Hospital will be enrolled in the study. Patients will be assigned
      to one of the two treatments by chance and followed for 6 months. The two treatment groups
      will be compared to see which treatment is more likely to make the patient better.
    

Detailed Description

      With the study hypothesis that Gatifloxacin is superior to Ceftriaxone in terms of treatment
      failure in patients with enteric fever, a comparative study will be conducted at Patan
      Hospital. 300 patients who are diagnosed with enteric fever will be enrolled into the study.
      The patients will be randomized to one of two groups. One group will receive treatment with
      Gatifloxacin for 7 days, and the other with Ceftriaxone. The patients will be followed during
      the treatment courses and at several points of 6 months after initial presentation. The
      endpoints then will be compared between two groups.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Rate of treatment failure

Secondary Outcome

 S.typhi or S.paratyphi carriage

Condition

Enteric Fever

Intervention

Ceftriaxone

Study Arms / Comparison Groups

 Gatifloxacin
Description:  Gatifloxacin 10mg/kg/day for 7 days

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

300

Start Date

September 2011

Completion Date

January 2015

Primary Completion Date

July 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Suspected or culture proven enteric fever

          -  >= 2 <= 45 years of age

          -  Fever >= 38°C for >= 4 days

          -  Informed consent to participate in the study

        Exclusion Criteria:

          -  Pregnancy

          -  Obtundation

          -  Shock

          -  Visible jaundice

          -  Presence of signs of gastrointestinal bleeding

          -  Evidence of severe disease

          -  Diabetes

          -  History of hypersensitivity to either of the trial drugs

          -  Known previous treatment with a quinolone antibiotic or 3rd generation cephalosporin
             or macrolide within one week of hospital admission.
      

Gender

All

Ages

2 Years - 45 Years

Accepts Healthy Volunteers

No

Contacts

Buddha Basnyat, MD, , 

Location Countries

Nepal

Location Countries

Nepal

Administrative Informations


NCT ID

NCT01421693

Organization ID

03NP


Responsible Party

Sponsor

Study Sponsor

Oxford University Clinical Research Unit, Vietnam

Collaborators

 University of Oxford

Study Sponsor

Buddha Basnyat, MD, Principal Investigator, University of Oxford


Verification Date

October 2016