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.
|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.|
- 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 Both the absolute risk of treatment failure and the time to treatment failure will be analyzed
- 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
- 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.
- Rate of culture-positive and syndromic clinical relapses [ Time Frame: within 28 days of starting therapy ] [ Designated as safety issue: No ]
- Rate of relapses confirmed using additional diagnostic techniques [ Time Frame: within 28 days of starting therapy ] [ Designated as safety issue: No ]Additional techniques will include culture-PCR and gene expression profiling.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||January 2015|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Gatifloxacin
Gatifloxacin 10mg/kg/day for 7 days
Gatifloxacin 10 mg/kg/day for 7 days. Tablets for oral administration.
Active Comparator: Ceftriaxone
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421693
|Principal Investigator:||Buddha Basnyat, MD||Oxford University Clinical Research Unit, Nepal|