Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

Typhoid Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421693
• Other study ID #: 03NP
• Status: Completed
• Phase: Phase 4
• First received: August 22, 2011
• Last updated: October 2, 2016
• Start date: September 2011
• Est. completion date: January 2015

Study information

• Verified date: October 2016
• Source: Oxford University Clinical Research Unit, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Nepal: Health Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enteric Fever
• Fever
• Typhoid Fever

Intervention

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

Locations

Country	Name	City	State
Nepal	Civil Hospital	Kathmandu
Nepal	Patan Hospital	Kathmandu

Sponsors (5)

Lead Sponsor	Collaborator
Oxford University Clinical Research Unit, Vietnam	Civil Hospital, Nepal, Patan Academy of Health Sciences, Nepal, Patan Hospital, Nepal, University of Oxford

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	upon occurance, within 28 days	No
Secondary	S.typhi or S.paratyphi carriage	Stool culture positive for S.typhi or S.paratyphi carriage	1 month, 3 months and 6 months	No
Secondary	Number of adverse events	Treatment tolerance as defined by the number of adverse events, serious adverse events and disease complications	within 6 months	No
Secondary	Household transmission	Total number of febrile episodes, hospital visits and hospital admissions within household members	within 6 months	No
Secondary	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.	upon occurance, within 7 days	No
Secondary	Rate of culture-positive and syndromic clinical relapses		within 28 days of starting therapy	No
Secondary	Rate of relapses confirmed using additional diagnostic techniques	Additional techniques will include culture-PCR and gene expression profiling.	within 28 days of starting therapy	No

External Links

•   Oxford University Clinical Research Unit, Nepal
•   Oxford University Clinical Research Unit, Viet Nam
•   Trial Ethical Approval letters and Informed Consent Forms