Condition category
Infections and Infestations
Date applied
16/07/2008
Date assigned
17/07/2008
Last edited
17/07/2008
Prospective/Retrospective
Prospectively 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 Maskey Pukar

ORCID ID

Contact details

Patan Hospital
GPO Box 252
Kathmandu
-
Nepal
+977 (0)1 985 107 9779
docpukarmaskey@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CTU02AVJUN08

Study information

Scientific title

Acronym

Study hypothesis

To understand why some people become chronic carriers of Salmonella we need to investigate the variation within the infecting pathogen and the host.

Ethics approval

Ethics approval received from the Oxford Tropical Medicine Research Ethics Committee (OXTREC) (UK) on the 25th June 2008 (ref: 21/08). The Nepal Health Research Committee (NHRC) has given verbal approval and the written approval will follow.

Study design

A prospective descriptive study

Primary study design

Interventional

Secondary study design

Cross-section survey

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

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

Condition

Enteric fever/tropical diseases

Intervention

1. Prior to admission to the study:
Full history and clinical examination. In particular the following data will be documented: clinical manifestations according to a standard case record form (CRF).

2. On admission to the study:
2.1. Name and address of the patient will be recorded on a detachable cover sheet of the CRF
2.2. Blood for on-going host genetic studies of enteric fever from the patient
2.3. Storage of serum for antibody analysis
2.4. Storage of blood for expression microarray profiling to identify biomarkers of carriage
2.5. Storage of bile and gallbladder
2.6. Culture of bile and gall stones (if present)
2.7. Stool culture

3. Follow up visit from health-workers after 3 months:
3.1. Stool culture
3.2. GPS mapping of patients house
3.3. The gallbladders and bile will be stored in appropriate media and temperatures for:
3.3.1. Polymerase chain reaction (PCR) of Salmonella deoxyribonucleic acid (DNA) in all samples that are culture negative
3.3.2. Bacterial ribonucleic acid (RNA) extraction for expression profiling of the organism
3.3.3. Routine histology of the organ
3.3.4. Immunohistochemistry of the tissue
3.3.5. Electron microscopy of the tissue
3.4. Blood and serum will be stored in appropriate media and temperatures for:
3.4.1. Storage of blood for expression microarray profiling to identify biomarkers of carriage
3.4.2. Blood for on-going host genetic studies of enteric fever from the patient
3.4.3. Storage of serum for antibody analysis
3.5. Storage of bacterial isolates; all strains isolated from the bile will be stored at -700°C for bacteriological assessment
3.6. Spatial clustering of typhoid fever cases

Patients will be visited twice daily at home by a member of the study team. At the first visit the staff member will record the patient's house in a global positioning system (GPS).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. The titre of Vi antibodies in patients from whom Salmonella is isolated
2. Specific histological characteristics favouring carriage of Salmonella
3. Traits of the bacterium favouring their chronic carriage

Secondary outcome measures

1. Investigation of the host genetic variation
2. The human expression profile involved with Salmonella carriage

Overall trial start date

01/08/2008

Overall trial end date

31/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

All patients referred for Cholecystectomy at Patan Hospital (no age limit, either sex) that complete the consent form and agree to be admitted to the study will be included in the study.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

1000

Participant exclusion criteria

Does not comply with the above inclusion criteria.

Recruitment start date

01/08/2008

Recruitment end date

31/07/2011

Locations

Countries of recruitment

Nepal

Trial participating centre

Patan Hospital
Kathmandu
-
Nepal

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
United Kingdom

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 077078)

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

Publication citations

Additional files

Editorial Notes