Investigation of the carriage of invasive Salmonellae in gall bladders in Kathmandu, Nepal
| ISRCTN | ISRCTN81497217 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81497217 |
| Secondary identifying numbers | CTU02AVJUN08 |
- Submission date
- 16/07/2008
- Registration date
- 17/07/2008
- Last edited
- 17/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Maskey Pukar
Scientific
Scientific
Patan Hospital
GPO Box 252
Kathmandu
-
Nepal
| Phone | +977 (0)1 985 107 9779 |
|---|---|
| docpukarmaskey@yahoo.com |
Study information
| Study design | A prospective descriptive study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cross-section survey |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/08/2008 |
| Completion date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 1000 |
| Key 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. |
| Key exclusion criteria | Does not comply with the above inclusion criteria. |
| Date of first enrolment | 01/08/2008 |
| Date of final enrolment | 31/07/2011 |
Locations
Countries of recruitment
- Nepal
Study participating centre
Patan Hospital
Kathmandu
-
Nepal
-
Nepal
Sponsor information
University of Oxford (UK)
University/education
University/education
Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
England
United Kingdom
| Website | http://www.ox.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 077078)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
