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NCT Number: NCT01421693

Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

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.

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Key information

Conditions

Enteric Fever Bacterial Infections Bacterial Infections and Mycoses Enterobacteriaceae Infections Gram-Negative Bacterial Infections Infections Salmonella Infections Typhoid Fever

Age range

2 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Civil Hospital, Kathmandu, Nepal

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ceftriaxone

Drug
  • ≥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.

Gatifloxacin

Drug

Gatifloxacin 10 mg/kg/day for 7 days. Tablets for oral administration.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Oxford University Clinical Research Unit, Vietnam

Other

Collaborators

  • Civil Hospital, Nepal
  • Patan Academy of Health Sciences, Nepal
  • Patan Hospital, Nepal
  • University of Oxford

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Aug 23, 2011
Registry last updated
Oct 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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