Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Enteric Fever Typhoid Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gatifloxacin

Gatifloxacin 10mg/kg/day for 7 days

Group Type ACTIVE_COMPARATOR

Gatifloxacin

Intervention Type DRUG

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

Ceftriaxone

* ≥2-\<14 years - 60mg/kg/ once daily for 7 days
* 14 years and older - 2g once daily for 7 days

Group Type ACTIVE_COMPARATOR

Ceftriaxone

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Gatifloxacin

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No