An observational study in Cholera and Diarrhea, sponsored by Brigham and Women's Hospital. Completed at 1 site in Haiti. Open to participants aged 12 Months and older. Per ClinicalTrials.gov, last updated 2019-07-10.
Sponsored by Brigham and Women's Hospital · Observational
The investigators aim to evaluated a public health program in Haiti that introduced an oral cholera vaccine as part of comprehensive control efforts for a major cholera epidemic. Although the vaccine (Shanchol(R)) had been demonstrated to be very safe, and effective at preventing cholera in many settings, it had not extensively been used to control an outbreak, and it had not been extensively studied in populations that were previously naive to cholera (i.e. countries that had never had cholera before). This cholera epidemic was the first ever report of cholera in Haiti.
After the cholera vaccination campaign was complete, the investigators aimed to evaluate the field efficacy of the vaccination campaign by evaluating the number of cases of cholera, and determining if cholera patients had been vaccinated. The investigators compared the rate of vaccination in cholera cases to controls from the community that had not had cholera in a case-control study.
The investigators also performed a second study - a bias-indicator study - that enrolled patients with non-cholera diarrhea, and community controls. The role of the bias-indicator study was to evaluate for potential sources of bias, since the investigators could expect that cholera vaccination should have no effect on non-cholera diarrhea.
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This study will be conducted in the catchment area of the vaccine campaign, in the rural regions of Bocozel and Grande Saline, located in the Artibonite Department of Haiti. Bocozel has a catchment population of approximately 56,000 people and Grande Saline has a catchment population of approximately 21,000 people. These two neighboring sections are one of two Haitian locations in which the two-dose Shanchol oral cholera vaccine will be implemented as part of the vaccination campaign in 2012. Key stakeholder meetings conducted by PIH staff among diverse groups of community members in Bocozel suggest broad acceptance of the vaccine. Based on these meetings and reported oral cholera vaccine uptake in other countries, we estimate that vaccine uptake will be 80% or higher in Bocozel.
Inclusion criteria for cholera cases:
Exclusion criteria for cholera cases:
Inclusion criteria for non-cholera diarrhea cases:
Exclusion criteria for non-cholera diarrhea cases:
Inclusion criteria for all controls:
Exclusion criteria for cholera controls and secondary controls:
\- Community members that did not have diarrhea between date of study commencement, and time of presentation of the case
\- Cases of acute watery diarrhea that present for healthcare at the study sites, but that test negative for cholera
\- Community members that did not have diarrhea between date of study commencement, and time of presentation of the case
\- Those with cholera-related diarrhea who present to healthcare at the study sites.
cholera-related diarrhea
Diarrhea will be determined by clinical symptoms of acute watery diarrhea (3 stools in the past 24 hours). 'Cholera' designation will be determined by rapid test and confirmed by bacteriologic culture.
Time frame: We will report diarrhea rates at 12 months after the cholera vaccination campaign
cholera-related diarrhea
Diarrhea will be determined by clinical symptoms of acute watery diarrhea (3 stools in the past 24 hours). 'Cholera' designation will be determined by rapid test and confirmed by bacteriologic culture.
Time frame: We will report diarrhea rates at 24 after the cholera vaccination campaign
cholera-related diarrhea
Diarrhea will be determined by clinical symptoms of acute watery diarrhea (3 stools in the past 24 hours). 'Cholera' designation will be determined by rapid test and confirmed by bacteriologic culture.
Time frame: We will report diarrhea rates at 60 months after the cholera vaccination campaign
non-cholera diarrhea
Diarrhea will be determined by clinical criteria for acute watery diarrhea (3 stools in the past 24 hours). 'Non-cholera' designation will be determined by rapid test for cholera and bacteriologic culture (negative rapid test, culture negative = 'non-cholera')
Time frame: We will report diarrhea rates at 12 months after the cholera vaccination campaign
non-cholera diarrhea
Diarrhea will be determined by clinical criteria for acute watery diarrhea (3 stools in the past 24 hours). 'Non-cholera' designation will be determined by rapid test for cholera and bacteriologic culture (negative rapid test, culture negative = 'non-cholera')
Time frame: We will report diarrhea rates at 24 months after the cholera vaccination campaign
non-cholera diarrhea
Diarrhea will be determined by clinical criteria for acute watery diarrhea (3 stools in the past 24 hours). 'Non-cholera' designation will be determined by rapid test for cholera and bacteriologic culture (negative rapid test, culture negative = 'non-cholera')
Time frame: We will report diarrhea rates at 60 months after the cholera vaccination campaign
The record gives a start of Oct 2012, a primary completion of Mar 2014 and a completion of Mar 2017. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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