Enteric fever (typhoid and paratyphoid fever) Infections and Infestations Typhoid and paratyphoid fevers
Conditions
Interventions
Gatifloxacin (10 mg/kg/day) once daily oral dose for 7 days versus ofloxacin (20 mg/kg/) twice daily oral dose for 7 days.
1. Prior to admission to the study:
1.1. Full history and clinical examinati
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients give fully informed consent 2. Aged above 2 years and weigh more than 10 kg, either sex 3. Patients with fever for more than 3 days 4. Patients have no signs of severe typhoid fever, are not obtunded or shocked, are not visibly jaundiced and have no signs of gastrointestinal bleeding or any other evidence of severity 5. No previous history of hypersensitivity to either of the trial drugs 6. No known previous treatment with a fluoroquinolone antibiotic or third generation cephalosporin or macrolide within one week of hospital admission (patients who have received chloramphenicol, ampicillin, or co-trimoxazole will be included as long as they have not shown evidence of clinical response) 7. Patients are not pregnant or breast-feeding
Exclusion criteria
Exclusion criteria: Does not comply with the above inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall failure of the treatment. Overall failure of treatment is defined as the occurrence of any one of the following (acute treatment failure plus complication plus relapse): 1. Persistent fever at day 10 of treatment 2. Blood culture positive at day 10 of treatment 3. Need for 'rescue' treatment with ceftriaxone 4. Culture confirmed relapse within 28 days of starting therapy 5. The development of any typhoid fever related complications during treatment: 5.1. Clinically significant bleeding 5.2. Fall in the Glasgow Coma Score 5.3. Perforation of the gastrointestinal tract 5.4. Admission to hospital within 28 days of starting therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fever clearance time (FCT) 2. Syndromic clinical relapse occurring within 28 days of starting therapy that is thought to be due to typhoid or paratyphoid fever (fever, abdominal pain, change in bowel habit, headache, etc), blood cultures negative and no other cause identified 3. Stool carriage of Salmonella typhi or S. paratyphi at 1, 3, or 6 months | — |
Countries
Nepal
Outcome results
None listed