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Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

Primary Purpose

Enteric Fever, Typhoid Fever

Status
Completed
Phase
Phase 4
Locations
Nepal
Study Type
Interventional
Intervention
Ceftriaxone
Gatifloxacin
Sponsored by
Oxford University Clinical Research Unit, Vietnam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Enteric Fever focused on measuring Gatifloxacin, Ceftriaxone, Enteric fever, Typhoid fever

Eligibility Criteria

2 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Civil Hospital
  • Patan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Gatifloxacin

Ceftriaxone

Arm Description

Gatifloxacin 10mg/kg/day for 7 days

≥2-<14 years - 60mg/kg/ once daily for 7 days 14 years and older - 2g once daily for 7 days

Outcomes

Primary Outcome Measures

Rate of treatment failure
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 Outcome Measures

S.typhi or S.paratyphi carriage
Stool culture positive for S.typhi or S.paratyphi carriage
Number of adverse events
Treatment tolerance as defined by the number of adverse events, serious adverse events and disease complications
Household transmission
Total number of febrile episodes, hospital visits and hospital admissions within household members
Time to fever clearance
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
Rate of relapses confirmed using additional diagnostic techniques
Additional techniques will include culture-PCR and gene expression profiling.

Full Information

First Posted
August 22, 2011
Last Updated
October 2, 2016
Sponsor
Oxford University Clinical Research Unit, Vietnam
Collaborators
University of Oxford, Patan Academy of Health Sciences, Nepal, Patan Hospital, Nepal, Civil Hospital, Nepal
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1. Study Identification

Unique Protocol Identification Number
NCT01421693
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oxford University Clinical Research Unit, Vietnam
Collaborators
University of Oxford, Patan Academy of Health Sciences, Nepal, Patan Hospital, Nepal, Civil Hospital, Nepal

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enteric Fever, Typhoid Fever
Keywords
Gatifloxacin, Ceftriaxone, Enteric fever, Typhoid fever

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gatifloxacin
Arm Type
Active Comparator
Arm Description
Gatifloxacin 10mg/kg/day for 7 days
Arm Title
Ceftriaxone
Arm Type
Active Comparator
Arm Description
≥2-<14 years - 60mg/kg/ once daily for 7 days 14 years and older - 2g once daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone
Intervention Description
≥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.
Intervention Type
Drug
Intervention Name(s)
Gatifloxacin
Intervention Description
Gatifloxacin 10 mg/kg/day for 7 days. Tablets for oral administration.
Primary Outcome Measure Information:
Title
Rate of treatment failure
Description
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
Time Frame
upon occurance, within 28 days
Secondary Outcome Measure Information:
Title
S.typhi or S.paratyphi carriage
Description
Stool culture positive for S.typhi or S.paratyphi carriage
Time Frame
1 month, 3 months and 6 months
Title
Number of adverse events
Description
Treatment tolerance as defined by the number of adverse events, serious adverse events and disease complications
Time Frame
within 6 months
Title
Household transmission
Description
Total number of febrile episodes, hospital visits and hospital admissions within household members
Time Frame
within 6 months
Title
Time to fever clearance
Description
Time from first dose of treatment until a temperature which is ≤37•5°C for a 48 hour period is first recorded.
Time Frame
upon occurance, within 7 days
Title
Rate of culture-positive and syndromic clinical relapses
Time Frame
within 28 days of starting therapy
Title
Rate of relapses confirmed using additional diagnostic techniques
Description
Additional techniques will include culture-PCR and gene expression profiling.
Time Frame
within 28 days of starting therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Buddha Basnyat, MD
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Civil Hospital
City
Kathmandu
Country
Nepal
Facility Name
Patan Hospital
City
Kathmandu
Country
Nepal

12. IPD Sharing Statement

Citations:
PubMed Identifier
26809813
Citation
Arjyal A, Basnyat B, Nhan HT, Koirala S, Giri A, Joshi N, Shakya M, Pathak KR, Mahat SP, Prajapati SP, Adhikari N, Thapa R, Merson L, Gajurel D, Lamsal K, Lamsal D, Yadav BK, Shah G, Shrestha P, Dongol S, Karkey A, Thompson CN, Thieu NTV, Thanh DP, Baker S, Thwaites GE, Wolbers M, Dolecek C. Gatifloxacin versus ceftriaxone for uncomplicated enteric fever in Nepal: an open-label, two-centre, randomised controlled trial. Lancet Infect Dis. 2016 May;16(5):535-545. doi: 10.1016/S1473-3099(15)00530-7. Epub 2016 Jan 20.
Results Reference
derived
Links:
URL
http://www.oucru.org
Description
Oxford University Clinical Research Unit, Viet Nam
URL
http://www.tropicalmedicine.ox.ac.uk/nepal
Description
Oxford University Clinical Research Unit, Nepal
URL
http://www.oucru.org/index.php?option=com_content&view=article&id=336&Itemid=111&lang=en
Description
Trial Ethical Approval letters and Informed Consent Forms

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Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

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