Clinical trial NCT01421693: Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever
Official title: Randomized, Open-label, Superiority Trial of the Effectiveness of Gatifloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Enteric Fever.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Enteric Fever
Typhoid Fever
Keywords: Gatifloxacin
Ceftriaxone
Enteric fever
Typhoid fever
Lead sponsor: Oxford University Clinical Research Unit, Vietnam
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: Patan Academy of Health Sciences, Nepal
name: Patan Hospital, Nepal
name: Civil Hospital, Nepal
First posted: 2011-08-23
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Rate of treatment failure
timeFrame: upon occurance, within 28 days
Secondary outcomes:
measure: S.typhi or S.paratyphi carriage
timeFrame: 1 month, 3 months and 6 months
measure: Number of adverse events
timeFrame: within 6 months
measure: Household transmission
timeFrame: within 6 months
measure: Time to fever clearance
timeFrame: upon occurance, within 7 days
measure: Rate of culture-positive and syndromic clinical relapses
timeFrame: within 28 days of starting therapy
measure: Rate of relapses confirmed using additional diagnostic techniques
timeFrame: within 28 days of starting therapy
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Civil Hospital
city: Kathmandu
country: Nepal
facility: Patan Hospital
Study officials:
affiliation: University of Oxford
name: Buddha Basnyat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arjyal A, Basnyat B, Nhan HT, Koirala S, Giri A, Joshi N, Shakya M, Pathak KR, Mahat SP, Prajapati SP, Adhikari N, Thapa R, Merson L, Gajurel D, Lamsal K, Lamsal D, Yadav BK, Shah G, Shrestha P, Dongol S, Karkey A, Thompson CN, Thieu NTV, Thanh DP, Baker S, Thwaites GE, Wolbers M, Dolecek C. Gatifloxacin versus ceftriaxone for uncomplicated enteric fever in Nepal: an open-label, two-centre, randomised controlled trial. Lancet Infect Dis. 2016 May;16(5):535-545. doi: 10.1016/S1473-3099(15)00530-7. Epub 2016 Jan 20.