Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

Overview

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.

Full Title of Study: “Randomized, Open-label, Superiority Trial of the Effectiveness of Gatifloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Enteric Fever.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2014

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.

Interventions

  • Drug: Ceftriaxone
    • ≥2-<14 years – 60mg/kg/ once daily for 7 days 14 years and older – 2g once daily for 7 days Intravenous infusion. Vials of crystalline powder.
  • Drug: Gatifloxacin
    • Gatifloxacin 10 mg/kg/day for 7 days. Tablets for oral administration.

Arms, Groups and Cohorts

  • Active Comparator: Gatifloxacin
    • Gatifloxacin 10mg/kg/day for 7 days
  • Active Comparator: Ceftriaxone
    • ≥2-<14 years – 60mg/kg/ once daily for 7 days 14 years and older – 2g once daily for 7 days

Clinical Trial Outcome Measures

Primary Measures

  • Rate of treatment failure
    • Time Frame: upon occurance, within 28 days
    • Any one (1) of the following defines treatment failure: Fever clearance time >7 x 24hours post treatment initiation Blood culture positive at Day 8 of treatment (microbiological failure) Requirement of rescue treatment Culture confirmed or syndromic relapse within 28 days of initiation of treatment The development on treatment of any enteric fever related complication within 28 days of initiation of treatment including, clinically significant bleeding, fall in the Glasgow Coma Score, perforation of the gastrointestinal tract or admission to hospital Both the absolute risk of treatment failure and the time to treatment failure will be analyzed

Secondary Measures

  • S.typhi or S.paratyphi carriage
    • Time Frame: 1 month, 3 months and 6 months
    • Stool culture positive for S.typhi or S.paratyphi carriage
  • Number of adverse events
    • Time Frame: within 6 months
    • Treatment tolerance as defined by the number of adverse events, serious adverse events and disease complications
  • Household transmission
    • Time Frame: within 6 months
    • Total number of febrile episodes, hospital visits and hospital admissions within household members
  • Time to fever clearance
    • Time Frame: upon occurance, within 7 days
    • Time from first dose of treatment until a temperature which is ≤37•5°C for a 48 hour period is first recorded.
  • Rate of culture-positive and syndromic clinical relapses
    • Time Frame: within 28 days of starting therapy
  • Rate of relapses confirmed using additional diagnostic techniques
    • Time Frame: within 28 days of starting therapy
    • Additional techniques will include culture-PCR and gene expression profiling.

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 2 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oxford University Clinical Research Unit, Vietnam
  • Collaborator
    • University of Oxford
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Buddha Basnyat, MD, Principal Investigator, University of Oxford

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