Status:
COMPLETED
Protective Immunity to Human Cholera in Bangladesh
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Cholera
Eligibility:
All Genders
18-45 years
Brief Summary
The purpose of this study is to better understand how the body fights and protects against cholera. Two hundered fifty people presenting to the International Centre for Diarrhoeal Diseases Research, B...
Detailed Description
Diarrheal diseases are some of the most common causes of morbidity and mortality in the world today. Unfortunately, effective vaccines for most of the infectious causes of diarrhea are not yet availab...
Eligibility Criteria
Inclusion
- For the esophagogastroduodenoscopy (EGD) substudy of 50 study participants
- Admission to the International Centre for Diarrhoeal Diseases Research, Bangladesh (ICDDR,B) with acute cholera
- Male or nonpregnant female \[pregnancy will be excluded by urine human chorionic gonadotropin (HCG) testing\]
- Age 18 to 45 years, inclusive
- Residence in Dhaka city
- Provision of informed consent for enrollment in study
- Expressed interest and availability to fulfill the study requirements
Exclusion
- For the esophagogastroduodenoscopy (EGD) substudy of 50 study participants
- Participation in any other investigational drug, device or vaccine trial at present or within the past 30 days
- Known allergy to midazolam or topical anesthetics
- Presence of comorbid conditions, including:
- heart disease
- pulmonary disease
- liver disease
- kidney disease
- bleeding disorder
- neurologic disorder
- an additional intestinal disorder
- pregnancy
- anemia (hemoglobin \< 12 g/dl for males or \< 11 g/dl for female)
- hypotension (systolic blood pressure less than or equal to 85 mm Hg or diastolic blood pressure less than or equal to 55 mm Hg, measured in the supine position once just prior to procedure)
- hypertension (systolic blood pressure greater than or equal to 150 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg, measured in the supine position once just prior to procedure)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00349999
Start Date
June 1 2008
End Date
December 1 2012
Last Update
September 9 2013
Active Locations (1)
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1
Dhaka Hospital - International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh, 1000