NCT01421693

Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Oxford University Clinical Research Unit, Vietnam · Academic / Other
• Sex: All
• Age: 2 Years – 45 Years
• Healthy volunteers: Not accepted

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 description

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

• Enteric Fever
• Typhoid Fever

Interventions

Type	Name	Description
DRUG	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.
DRUG	Gatifloxacin	Gatifloxacin 10 mg/kg/day for 7 days. Tablets for oral administration.

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-07-01
• Completion: 2015-01-01
• First posted: 2011-08-23
• Last updated: 2016-10-04

Locations

2 sites across 1 country: Nepal