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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01421693
Other study ID # 03NP
Secondary ID
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


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
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