Enteric Fever, Typhoid Fever
Conditions
Keywords
Gatifloxacin, Ceftriaxone, Enteric fever, Typhoid fever
Brief 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.
Interventions
DRUGCeftriaxone
* ≥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.
DRUGGatifloxacin
Gatifloxacin 10 mg/kg/day for 7 days. Tablets for oral administration.
Sponsors
University of Oxford
Patan Academy of Health Sciences, Nepal
Patan Hospital, Nepal
Civil Hospital, Nepal
Oxford University Clinical Research Unit, Vietnam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of treatment failure | upon occurance, within 28 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | within 6 months | Treatment tolerance as defined by the number of adverse events, serious adverse events and disease complications |
| Household transmission | within 6 months | Total number of febrile episodes, hospital visits and hospital admissions within household members |
| S.typhi or S.paratyphi carriage | 1 month, 3 months and 6 months | Stool culture positive for S.typhi or S.paratyphi carriage |
| Rate of culture-positive and syndromic clinical relapses | within 28 days of starting therapy | — |
| Rate of relapses confirmed using additional diagnostic techniques | within 28 days of starting therapy | Additional techniques will include culture-PCR and gene expression profiling. |
| Time to fever clearance | upon occurance, within 7 days | Time from first dose of treatment until a temperature which is ≤37•5°C for a 48 hour period is first recorded. |
Countries
Nepal
Outcome results
None listed