Condition category
Digestive System
Date applied
15/01/2008
Date assigned
18/01/2008
Last edited
13/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vinh Ha

ORCID ID

Contact details

Oxford University Clinical Research Unit
Hospital for Tropical Diseases
Ho Chi Minh City
5
Viet Nam
+84 8 9237954
vinhh@oucru.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

061330

Study information

Scientific title

A randomised controlled trial of gatifloxacin versus ciprofloxacin for the treatment of bacillary dysentery in children

Acronym

EG

Study hypothesis

In 2004, The World Health Organization (WHO) organised a meeting of experts around the world and recommended that ciprofloxacin or other fluoroquinolones should be used to treat shigellosis in children as well as adults. However after being used for some years to treat shigellosis, the clinical response to ciprofloxacin treatment has decreased, strains of Shigella dysenteriae type 1 resistant to ciprofloxacin were also detected. This is why searching for alternative regimens is obviously needed. This study will compare the currently recommended WHO regimen with a newer, affordable and potentially more active fluoroquinolone, i.e., gatifloxacin.

Ethics approval

Ethics approval received from Oxford Tropical Research Ethics Committee on the 20th June 2006 (ref: OXTREC 010-06).

Study design

Open-label randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Shigella dysentery

Intervention

Patients are randomised to:
1. Ciprofloxacin 15 mg/kg body weight taken orally every 12 hours for a total of 6 doses in 3 days, or
2. Gatifloxacin 10 mg/kg body weight taken orally every 24 hours for a total of 3 doses in 3 days

Follow-up will occur for 7 - 10 days after discharge from the hospital.

Intervention type

Drug

Phase

Not Specified

Drug names

Ciprofloxacin, gatifloxacin

Primary outcome measures

Failure of treatment:
1. Persistent fever at Day 5
2. Failure to clear completely the admission symptoms at Day 5
3. Stool culture positive at Day 3 of treatment
4. Need for ‘rescue’ treatment with ceftriaxone
5. The development on treatment of any complication

Secondary outcome measures

1. Fever clearance time: from the start of treatment until axillary temperature falls to 37.5°C and remains at or below this value for greater than 48 hours
2. Bloody diarrhoea clearance time: the time to the last stool containing visible blood passed
3. Diarrhoea clearance time: the time to the first formed stool
4. Bacterial clearance time: time to the last positive stools culture for Shigella

Overall trial start date

01/06/2006

Overall trial end date

30/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 0 - 14, either sex
2. Symptomatic uncomplicated dysentery
3. Gives consent

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

366

Participant exclusion criteria

No consent given.

Recruitment start date

01/06/2006

Recruitment end date

30/03/2009

Locations

Countries of recruitment

Viet Nam

Trial participating centre

Oxford University Clinical Research Unit
Ho Chi Minh City
5
Viet Nam

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 270143
research.services@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.ox.ac.uk

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 061330)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/20003464
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21829747

Publication citations

  1. Results

    Vinh H, Nhu NT, Nga TV, Duy PT, Campbell JI, Hoang NV, Boni MF, My PV, Parry C, Nga TT, Van Minh P, Thuy CT, Diep TS, Phuong le T, Chinh MT, Loan HT, Tham NT, Lanh MN, Mong BL, Anh VT, Bay PV, Chau NV, Farrar J, Baker S, A changing picture of shigellosis in southern Vietnam: shifting species dominance, antimicrobial susceptibility and clinical presentation., BMC Infect. Dis., 2009, 9, 204, doi: 10.1186/1471-2334-9-204.

  2. Results

    Vinh H, Anh VT, Anh ND, Campbell JI, Hoang NV, Nga TV, Nhu NT, Minh PV, Thuy CT, Duy PT, Phuong le T, Loan HT, Chinh MT, Thao NT, Tham NT, Mong BL, Bay PV, Day JN, Dolecek C, Lan NP, Diep TS, Farrar JJ, Chau NV, Wolbers M, Baker S, A multi-center randomized trial to assess the efficacy of gatifloxacin versus ciprofloxacin for the treatment of shigellosis in Vietnamese children., PLoS Negl Trop Dis, 2011, 5, 8, e1264, doi: 10.1371/journal.pntd.0001264.

Additional files

Editorial Notes