Clinical Trial: Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Oxford University Clinical Research Unit, Vietnam

Current Primary Outcome: Rate of treatment failure [ Time Frame: upon occurance, within 28 days ]

Original Primary Outcome:

• 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
  • Persistence of admission symptoms > 7 x 24 hours post treatment initiation
  • Blood culture positive at Day 8 of treatment
  • Requirement of rescue treatment
  • Culture confirmed relapse within 28 days of initiation of treatment
  • The development on treatment of any 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 ]
  Time from first dose of treatment until a temperature which is ≤37•5°C for a 48 hour period is first recorded.

Current Secondary Outcome:

• 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.

Original Secondary Outcome:

• 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

Information By: Oxford University Clinical Research Unit, Vietnam

Dates:
Date Received: August 22, 2011
Date Started: September 2011
Date Completion:
Last Updated: October 2, 2016
Last Verified: October 2016