Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Buddha Basnyat


Contact details

Patan Hospital
+977 (0)1 44 34642/18774

Additional identifiers

EudraCT number number

Protocol/serial number

061330; OXTREC 002-06

Study information

Scientific title



Study hypothesis

There has been a steady change in Kathmandu in the sensitivity of Salmonella typhi (the bacteria that causes typhoid fever) to all antibiotics. In Kathmandu in 2005 less than 5% of isolates are resistant to first line antibiotics including Chloramphenicol but they do show significantly poorer clinical response to the older fluoroquinolones (Ciprofloxacin and Ofloxacin) with high rates of Nalidixic acid resistance. There has been interest in Kathmandu and in the Indian Sub-Continent about returning to the use of the classical antibiotics for typhoid including Chloramphenicol. It is unclear in this environment, whether this is a reliable therapy for enteric fever or whether Gatifloxacin, a new generation and affordable floroquinolone, would be the better choice.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Typhoid fever


Gatifloxacin versus Chloramphenicol.

Added as of 20/09/2007:
This trial was stopped temporarily in September 2006 at the request of the Nepal Health Research Council and Department of Drug Administration after the reports of dysglycaemia associated with gatifloxacin.

The trial was resumed on Dec 2006 after the ethical committee and the Drug Administration authority were assured that dysglycaemia was not a problem in the young population who are most affected by enteric fever and all the patients in the trial were monitored closely for any dysglycaemia by fingerprick glucose testing.

Please note that due to the reasons stated above, the anticipated end date of this trial has changed. The previous end date of this trial was 30th April 2007.

Intervention type



Not Specified

Drug names

Gatifloxacin, Chloramphenicol

Primary outcome measure

Failure of treatment defined as the occurrence of any one of the following:
1. Persistent fever at day ten of treatment
2. Failure to clear completely the admission symptoms at day ten
3. Blood culture positive at day ten of treatment
4. Need for 'rescue' treatment with ceftriaxone
5. Culture confirmed relapse within 28 days of starting therapy
6. The development on treatment of any complication:
6.1 Clinically significant bleeding
6.2. Fall in the Glasgow Coma Score
6.3. Perforation of the gastrointestinal tract
6.4. Admission to hospital within 28 days of starting therapy

Secondary outcome measures

No secondary outcome measures

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)

This trial was stopped in September 2006 but has since restarted again (see interventions for more details of this - 20/09/07).
In the light of the reports on dysglycaemia in elderly patients in North American the Dept of Drug Administration (DDA) in Nepal have asked us to provide some additional information on Gatifloxacin. Whilst providing this additional information and following discussion with the DDA and the Nepal Health Research Council, we have suspended the study.

As the investigators, we have had no cause for concern during the study and have not identified any problems with glycaemic control on history taking, regular blood glucose monitoring and during the follow up of the study. We are in the process of providing the additional information requested and will let you know of the decision of the DDA as soon as we know of it.

We hope that we will be able to restart the study following their recommendation. At the time of suspension we have recruited 404 patients, 180 with confirmed enteric fever. As a randomised study we do not feel that the suspension has an impact on the study conduct whilst we wait for the decision.


Participant inclusion criteria

Any patient with suspected uncomplicated enteric fever who gives consent.

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. No consent
2. Pregnancy

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Patan Hospital

Sponsor information


University of Oxford (UK)

Sponsor details

University Offices
Wellington Square
United Kingdom
+44 (0)1865 270143

Sponsor type




Funder type


Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

1. 2011 results in

Publication citations

  1. Results

    Arjyal A, Basnyat B, Koirala S, Karkey A, Dongol S, Agrawaal KK, Shakya N, Shrestha K, Sharma M, Lama S, Shrestha K, Khatri NS, Shrestha U, Campbell JI, Baker S, Farrar J, Wolbers M, Dolecek C, Gatifloxacin versus chloramphenicol for uncomplicated enteric fever: an open-label, randomised, controlled trial., Lancet Infect Dis, 2011, 11, 6, 445-454, doi: 10.1016/S1473-3099(11)70089-5.

Additional files

Editorial Notes