A Phase 4 interventional study of Ceftriaxone and Gatifloxacin in Enteric Fever and Typhoid Fever, sponsored by Oxford University Clinical Research Unit, Vietnam. Completed at 2 sites in Nepal. Open to participants aged 2 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-10-04.
Sponsored by Oxford University Clinical Research Unit, Vietnam · Phase 4, Interventional, and Treatment
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.
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.
74 studies on the registry are indexed under Typhoid Fever; 10 are open to participants now.
This study's enrollment of 300 is above the median of 149 across 64 interventional studies indexed under Typhoid Fever.
Browse Typhoid Fever studies →Oxford University Clinical Research Unit, Vietnam is the lead sponsor of 36 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Gatifloxacin 10mg/kg/day for 7 days
Drug: Gatifloxacin
* ≥2-\<14 years - 60mg/kg/ once daily for 7 days * 14 years and older - 2g once daily for 7 days
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 10 mg/kg/day for 7 days. Tablets for oral administration.
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
Time frame: upon occurance, within 28 days
S.typhi or S.paratyphi carriage
Stool culture positive for S.typhi or S.paratyphi carriage
Time frame: 1 month, 3 months and 6 months
Number of adverse events
Treatment tolerance as defined by the number of adverse events, serious adverse events and disease complications
Time frame: within 6 months
Household transmission
Total number of febrile episodes, hospital visits and hospital admissions within household members
Time frame: within 6 months
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.
Time frame: upon occurance, within 7 days
Rate of culture-positive and syndromic clinical relapses
Time frame: within 28 days of starting therapy
Rate of relapses confirmed using additional diagnostic techniques
Additional techniques will include culture-PCR and gene expression profiling.
Time frame: within 28 days of starting therapy
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Oxford University Clinical Research Unit, Vietnam