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Trial record 1 of 1 for:    NCT01421693
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Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

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ClinicalTrials.gov Identifier: NCT01421693
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : October 4, 2016
University of Oxford
Patan Academy of Health Sciences, Nepal
Patan Hospital, Nepal
Civil Hospital, Nepal
Information provided by (Responsible Party):
Oxford University Clinical Research Unit, Vietnam

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.

Condition or disease Intervention/treatment Phase
Enteric Fever Typhoid Fever Drug: Ceftriaxone Drug: Gatifloxacin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : September 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. Household transmission [ Time Frame: within 6 months ]
    Total number of febrile episodes, hospital visits and hospital admissions within household members

  4. 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.

  5. Rate of culture-positive and syndromic clinical relapses [ Time Frame: within 28 days of starting therapy ]
  6. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01421693

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Civil Hospital
Kathmandu, Nepal
Patan Hospital
Kathmandu, Nepal
Sponsors and Collaborators
Oxford University Clinical Research Unit, Vietnam
University of Oxford
Patan Academy of Health Sciences, Nepal
Patan Hospital, Nepal
Civil Hospital, Nepal
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Principal Investigator: Buddha Basnyat, MD University of Oxford
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier: NCT01421693    
Other Study ID Numbers: 03NP
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Keywords provided by Oxford University Clinical Research Unit, Vietnam:
Enteric fever
Typhoid fever
Additional relevant MeSH terms:
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Typhoid Fever
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Anti-Bacterial Agents
Anti-Infective Agents
Ophthalmic Solutions
Pharmaceutical Solutions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents