Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

Condition(s) targeted: Enteric Fever; Typhoid Fever

Intervention: Ceftriaxone (Drug); Gatifloxacin (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Oxford University Clinical Research Unit, Vietnam

Official(s) and/or principal investigator(s):
Buddha Basnyat, MD, Principal Investigator, Affiliation: Oxford University Clinical Research Unit, Nepal

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.

Official title: Randomized, Open-label, Superiority Trial of the Effectiveness of Gatifloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Enteric Fever.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Rate of treatment failure

Secondary outcome:

S.typhi or S.paratyphi carriage

Number of adverse events

Household transmission

Time to fever clearance

Rate of culture-positive and syndromic clinical relapses

Rate of relapses confirmed using additional diagnostic techniques

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.

Minimum age: 2 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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.

Civil Hospital, Kathmandu, Nepal

Patan Hospital, Kathmandu, Nepal

Oxford University Clinical Research Unit, Viet Nam

Oxford University Clinical Research Unit, Nepal

Trial Ethical Approval letters and Informed Consent Forms

Starting date: September 2011
Last updated: November 26, 2014