Status:
TERMINATED
High Amylose Maize Starch for Treatment of Cholera
Lead Sponsor:
PATH
Conditions:
Diarrhea
Eligibility:
MALE
18-65 years
Brief Summary
A randomized, double-blind trial in adult males with acute dehydrating diarrhea of cholera comparing the safety, tolerability and efficacy of HAMS HO-ORS, HAMS 2.5% Acetate HO-ORS, HAMS 6% Acetate HO-...
Detailed Description
* Burden: Watery diarrhea including cholera continues to be a major cause of childhood mortality in developing countries, with an estimated 1.5 million children dying each year. This figure has greatl...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- A participant is considered eligible for participation in the trial if the following inclusion criteria are satisfied on admission (Day 1, before randomization) to the hospital:
- Participant is a male between 18 and 65 years of age inclusive
- Severe watery diarrhea without fecal blood of less than 48 hours (with passage of 3 or more watery stools in the 24 hours before admission)
- Signs of severe dehydration as per ICDDR,B guidelines (modified WHO guideline)
- Dipstick test/Dark-field examination positive for Vibrio cholera
- Written informed consent is provided
- Participant is willing and able to comply with all trial requirements
- EXCLUSION CRITERIA:
- A participant who meets any of the following criteria on admission (before randomization) to the hospital will not qualify for the study
- Evidence or history of any clinically significant illness as per the Investigator's discretion.
- Known case of HIV or Hepatitis B
- History of cancer
- Known renal disease
- Frequent excessive alcohol use, binge drinking (e.g. men consume 5 or more drinks in about 2 hours) or use of illicit drugs within the past two years
- History of receiving antimicrobial or anti-diarrheal medication (loperamide, diphenoxylate, etc.) within seven days of admission
- Concomitant infection requiring antimicrobial therapy
- Donated blood or plasma or experienced clinically significant loss of blood within eight weeks prior to admission or who plan to donate blood within 1 month after study participation
- Clinically significant abnormal laboratory test results as determined by the investigator
- Treatment within 30 days prior to admission (or five half-lives of the compound, if longer) with any investigational agent or device
- History of seizure (including febrile seizure) or loss of consciousness;
- History of any GI Surgery related to Bowel resections and gastric anastomoses in past except Appendicitis
- For any reason, deemed by the investigator to be inappropriate for this study, including participants who are unable to communicate or to cooperate with the investigator or designee
- Prior enrolment in this trial
Exclusion
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01823952
Start Date
April 1 2013
End Date
February 1 2014
Last Update
April 4 2014
Active Locations (1)
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1
Dhaka Hospital - icddr,b (International Centre for Diarrhoeal Disease Research, Bangladesh)
Mohakhali, Dhaka Division, Bangladesh, 1212