Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

Oxford University Clinical Research Unit, Vietnam300 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Enteric Fever Typhoid Fever

Interventions

CeftriaxoneDRUG

* ≥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.

GatifloxacinDRUG

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

Eligibility

Sex: ALLMin age: 2 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (2)

Civil Hospital

Kathmandu, Nepal

Patan Hospital

Kathmandu, Nepal

Outcomes

Primary Outcomes

Rate of treatment failure

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

Time frame: upon occurance, within 28 days

Secondary Outcomes

S.typhi or S.paratyphi carriage

Stool culture positive for S.typhi or S.paratyphi carriage

Time frame: 1 month, 3 months and 6 months

Number of adverse events

Treatment tolerance as defined by the number of adverse events, serious adverse events and disease complications

Time frame: within 6 months

Household transmission

Total number of febrile episodes, hospital visits and hospital admissions within household members

Time frame: within 6 months

Time to fever clearance

Time from first dose of treatment until a temperature which is ≤37•5°C for a 48 hour period is first recorded.

Time frame: upon occurance, within 7 days

Rate of culture-positive and syndromic clinical relapses

Time frame: within 28 days of starting therapy

Data from ClinicalTrials.gov

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