Status:
COMPLETED
Investigating Enteric Fever - Salmonella Typhi and Paratyphi Challenge Study
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
University of Liverpool
Brigham and Women's Hospital
Conditions:
Typhoid Fever
Paratyphoid Fever
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Enteric fever, an infection characterised by diarrhoea and rash, is most often caused by a bacteria called Salmonella enterica. After ingesting contaminated food or drink, the Salmonellae travel first...
Detailed Description
There are two main groups in this study. Firstly a group of 40 to 60 volunteers recruited from the community and not previously exposed to typhoidal Salmonella (part A); secondly a group of 20 to 60 v...
Eligibility Criteria
Inclusion
- In good health as determined by medical history, physical examination and clinical judgment of the investigators.
- Agree (in the Investigator's opinion) to comply with all study requirements, including capacity to adhere to good personal hygiene and infection control precautions.
- Agree to allow his or her General Practitioner (and/or Consultant if appropriate), to be notified of participation in the study.
- Agree to allow Public Health England to be informed of their participation in the study .
- Agree to give his or her close household contacts written information informing them of the participants' involvement in the study and offering them voluntary screening for S. Typhi or S. Paratyphi carriage.
- Agree to have 24-hour contact with study staff during the four weeks post challenge and are able to ensure that they are contactable by mobile phone for the duration of the challenge period until antibiotic completion.
- Have internet access to allow completion of the e-diary and real-time safety monitoring.
- Agree to avoid antipyretic/anti-inflammatory treatment until advised by a study doctor or until at least 14 days after challenge.
- Willing to undergo endoscopy and biopsy.
Exclusion
- History of significant organ/system disease that could interfere with study conduct or completion.
- Have any known or suspected impairment of immune function, alteration of immune function, or prior immune exposure that may alter immune function.
- Moderate or severe depression or anxiety as classified by the Hospital Anxiety and Depression Score at screening or challenge that is deemed clinically significant by the study investigators.
- Weight 50kg or less.
- Presence of implants or prosthesis.
- Have previously received any typhoid vaccine
- Any contraindication to elective upper GI endoscopy.
- More than one non-study related upper GI endoscopy within the last year.
- Anyone taking long-term medication that may affect symptom reporting or interpretation of the study results.
- Contra-indication to taking ciprofloxacin, azithromycin, trimethoprim/ sulfamethoxazole and/or beta lactam antibiotics.
- Female participants who are pregnant or lactating.
- Female participants who are unwilling to ensure that they or their partner use effective contraception one month prior to challenge and continue to do so until two negative stool samples, a minimum of three weeks after completion of antibiotic treatment, have been obtained.
- Full-time, part-time or voluntary occupations involving clinical or social work with direct contact with young children (defined as those attending pre-school groups or nursery or aged under 2 years); clinical or social work with direct contact with highly susceptible patients or persons in whom typhoid or paratyphoid infection would have particularly serious consequences e.g. the elderly or infirm.
- Full time, part time or voluntary occupations involving commercial food handling.
- Close household contact with young children (defined as those attending pre-school groups, nursery or those aged less than 2 years), individual(s) who is (are) immunocompromised, scheduled elective surgery or other procedures requiring general anaesthesia during the study period.
- Participants who have participated in another research study involving an investigational product that might affect risk of typhoid or paratyphoid infection or compromise the integrity of the study within the 30 days prior to enrolment .
- Detection of any significantly abnormal results from screening investigations.
- Inability to comply with any of the study requirements.
- Any other social, psychological or health issues which, in the opinion of the study investigator, may put the participants or their contacts at risk because of participation in the study, adversely affect the interpretation of the primary endpoint data, or impair the participant's ability to participate in the study.
- Having been resident in an enteric fever endemic country for six months or more.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2022
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT02192008
Start Date
December 1 2014
End Date
May 26 2022
Last Update
June 2 2022
Active Locations (1)
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1
Oxford Vaccine Group
Oxford, Oxfordshire, United Kingdom, OX3 7LE