Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

Oxford University Clinical Research Unit, Vietnam

Status and phase

Completed

Phase 4

Conditions

Typhoid Fever

Enteric Fever

Treatments

Drug: Ceftriaxone

Drug: Gatifloxacin

Study type

Interventional

Funder types

Other

Identifiers

NCT01421693

03NP

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 patients

Sex

All

Ages

2 to 45 years old

Volunteers

No Healthy Volunteers

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.