NCT01421693

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2011

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2011

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

October 4, 2016

Status Verified

October 1, 2016

Enrollment Period

2.8 years

First QC Date

August 22, 2011

Last Update Submit

October 2, 2016

Conditions

Enteric FeverTyphoid Fever

Keywords

GatifloxacinCeftriaxoneEnteric feverTyphoid fever

Outcome Measures

Primary Outcomes (1)

  • 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

    upon occurance, within 28 days

Secondary Outcomes (6)

  • S.typhi or S.paratyphi carriage

    1 month, 3 months and 6 months

  • Number of adverse events

    within 6 months

  • Household transmission

    within 6 months

  • Time to fever clearance

    upon occurance, within 7 days

  • Rate of culture-positive and syndromic clinical relapses

    within 28 days of starting therapy

  • +1 more secondary outcomes

Study Arms (2)

Gatifloxacin

ACTIVE COMPARATOR

Gatifloxacin 10mg/kg/day for 7 days

Drug: Gatifloxacin

Ceftriaxone

ACTIVE COMPARATOR

* ≥2-\<14 years - 60mg/kg/ once daily for 7 days * 14 years and older - 2g once daily for 7 days

Drug: Ceftriaxone

Interventions

CeftriaxoneDRUG

* ≥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.

Ceftriaxone
GatifloxacinDRUG

Gatifloxacin 10 mg/kg/day for 7 days. Tablets for oral administration.

Gatifloxacin

Eligibility Criteria

Age2 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Suspected or culture proven enteric fever
  • \>= 2 \<= 45 years of age
  • Fever \>= 38°C for \>= 4 days
  • Informed consent to participate in the study

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Civil Hospital

Kathmandu, Nepal

Location

Patan Hospital

Kathmandu, Nepal

Location

Related Publications (1)

  • 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.

    PMID: 26809813DERIVED

Related Links

MeSH Terms

Conditions

Typhoid Fever

Interventions

CeftriaxoneGatifloxacin

Condition Hierarchy (Ancestors)

Salmonella InfectionsEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

CefotaximeCephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsFluoroquinolones4-QuinolonesQuinolonesQuinolines

Study Officials

  • Buddha Basnyat, MD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2011

First Posted

August 23, 2011

Study Start

September 1, 2011

Primary Completion

July 1, 2014

Study Completion

January 1, 2015

Last Updated

October 4, 2016

Record last verified: 2016-10

Locations

NE(2)