Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Oxford University Clinical Research Unit, Nepal
Patan Academy of Health Sciences, Nepal
Patan Hospital, Nepal
Civil Hospital, Nepal
Information provided by (Responsible Party):
Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier:
NCT01421693
First received: August 22, 2011
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Enteric Fever
Typhoid Fever
Drug: Ceftriaxone
Drug: Gatifloxacin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Open-label, Superiority Trial of the Effectiveness of Gatifloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Enteric Fever.

Resource links provided by NLM:


Further study details as provided by Oxford University Clinical Research Unit, Vietnam:

Primary Outcome Measures:
  • Rate of treatment failure [ Time Frame: upon occurance, within 28 days ] [ Designated as safety issue: No ]

    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

  • Time to fever clearance [ Time Frame: upon occurance, within 7 days ] [ Designated as safety issue: No ]
    Time from first dose of treatment until a temperature which is ≤37•5°C for a 48 hour period is first recorded.


Secondary Outcome Measures:
  • S.typhi or S.paratyphi carriage [ Time Frame: 1 month, 3 months and 6 months ] [ Designated as safety issue: No ]
    Stool culture positive for S.typhi or S.paratyphi carriage

  • Number of adverse events [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
    Treatment tolerance as defined by the number of adverse events, serious adverse events and disease complications

  • Household transmission [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
    Total number of febrile episodes, hospital visits and hospital admissions within household members


Estimated Enrollment: 300
Study Start Date: September 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gatifloxacin
Gatifloxacin 10mg/kg/day for 7 days
Drug: Gatifloxacin
Gatifloxacin 10 mg/kg/day for 7 days. Tablets for oral administration.
Active Comparator: Ceftriaxone
  • ≥2-<14 years - 60mg/kg/ once daily for 7 days
  • 14 years and older - 2g once daily for 7 days
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.

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.

  Eligibility

Ages Eligible for Study:   2 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421693

Locations
Nepal
Patan Hospital
Kathmandu, Nepal
Civil Hospital
Kathmandu, Nepal
Sponsors and Collaborators
Oxford University Clinical Research Unit, Vietnam
Oxford University Clinical Research Unit, Nepal
Patan Academy of Health Sciences, Nepal
Patan Hospital, Nepal
Civil Hospital, Nepal
Investigators
Principal Investigator: Buddha Basnyat, MD Oxford University Clinical Research Unit, Nepal
  More Information

Additional Information:
No publications provided

Responsible Party: Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier: NCT01421693     History of Changes
Other Study ID Numbers: 03NP
Study First Received: August 22, 2011
Last Updated: July 14, 2014
Health Authority: Nepal: Health Research Council

Keywords provided by Oxford University Clinical Research Unit, Vietnam:
Gatifloxacin
Ceftriaxone
Enteric fever
Typhoid fever

Additional relevant MeSH terms:
Fever
Typhoid Fever
Body Temperature Changes
Signs and Symptoms
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Gatifloxacin
Fluoroquinolones
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014