Title
Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever
Randomized, Open-label, Superiority Trial of the Effectiveness of Gatifloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Enteric Fever.
Phase
Phase 4Lead Sponsor
University of OxfordStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Enteric Fever Typhoid FeverIntervention/Treatment
ceftriaxone gatifloxacin ...Study Participants
300The 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.
≥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.
≥2-<14 years - 60mg/kg/ once daily for 7 days 14 years and older - 2g once daily for 7 days
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.
