Exclusion Criteria
Item
Exclusion Criteria
boolean
C0680251 (UMLS CUI [1,1])
Fever > 100.3°F
Item
Fever > 100.3°F
boolean
C0015967 (UMLS CUI [1,1])
Symptoms of acute gastroenteritis >/= 72 hours duration
Item
Symptoms of acute gastroenteritis >/= 72 hours duration
boolean
C1457887 (UMLS CUI [1,1])
C0267446 (UMLS CUI [1,2])
Known or suspected infection or co-infection with a non-bacterial pathogen, such as viral or parasitic gastroenteritis
Item
Known or suspected infection or co-infection with a non-bacterial pathogen, such as viral or parasitic gastroenteritis
boolean
C0205309 (UMLS CUI [1,1])
C0332147 (UMLS CUI [1,2])
C3714514 (UMLS CUI [1,3])
C0275524 (UMLS CUI [1,4])
C0450254 (UMLS CUI [1,5])
C0521009 (UMLS CUI [1,6])
C1518422 (UMLS CUI [1,7])
C0521026 (UMLS CUI [1,8])
C0521066 (UMLS CUI [1,9])
Bloody diarrhea
Item
Bloody diarrhea
boolean
C0151594 (UMLS CUI [1,1])
History of inflammatory bowel disease
Item
History of inflammatory bowel disease
boolean
C0262926 (UMLS CUI [1,1])
C0021390 (UMLS CUI [1,2])
Treatment with an antimicrobial agent within 30 days prior to screening
Item
Treatment with an antimicrobial agent within 30 days prior to screening
boolean
C0087111 (UMLS CUI [1,1])
C1136254 (UMLS CUI [1,2])
C4028326 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0220908 (UMLS CUI [1,5])
Treatment with > 2 doses of an anti-diarrheal medicine within 24 hours prior to study entry, or the anticipated need for such therapy (including, but not limited to, bismuth subsalicylate, loperamide, and attapulgite) during study treatment
Item
Treatment with > 2 doses of an anti-diarrheal medicine within 24 hours prior to study entry, or the anticipated need for such therapy (including, but not limited to, bismuth subsalicylate, loperamide, and attapulgite) during study treatment
boolean
C0087111 (UMLS CUI [1,1])
C0718565 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,4])
C1830593 (UMLS CUI [1,5])
C0053792 (UMLS CUI [1,6])
C0023992 (UMLS CUI [1,7])
C0052657 (UMLS CUI [1,8])
Concomitant need or use of any other oral, intramuscular or intravenous antibacterial with expected activities against enteric bacterial pathogens including a fluoroquinolone, macrolide, trimethoprim-sulfamethoxazole, doxycycline, or other potentially effective drug
Item
Concomitant need or use of any other oral, intramuscular or intravenous antibacterial with expected activities against enteric bacterial pathogens including a fluoroquinolone, macrolide, trimethoprim-sulfamethoxazole, doxycycline, or other potentially effective drug
boolean
C1707479 (UMLS CUI [1,1])
C0279516 (UMLS CUI [1,2])
C0442117 (UMLS CUI [1,3])
C0442027 (UMLS CUI [1,4])
C0348016 (UMLS CUI [1,5])
C4316902 (UMLS CUI [1,6])
C0450254 (UMLS CUI [1,7])
C0041044 (UMLS CUI [1,8])
C0013090 (UMLS CUI [1,9])
C0282563 (UMLS CUI [1,10])
C0949665 (UMLS CUI [1,11])
Participation in other clinical research studies utilizing an investigational agent within one month prior to screening or within five half-lives of the investigational agent, whichever is longer
Item
Participation in other clinical research studies utilizing an investigational agent within one month prior to screening or within five half-lives of the investigational agent, whichever is longer
boolean
C0679823 (UMLS CUI [1,1])
C0681814 (UMLS CUI [1,2])
C0013223 (UMLS CUI [1,3])
C4745138 (UMLS CUI [1,4])
C0332152 (UMLS CUI [1,5])
C0220908 (UMLS CUI [1,6])
C0678761 (UMLS CUI [1,7])
Period of stay in the travel destination of < 72 hours
Item
Period of stay in the travel destination of < 72 hours
boolean
C0023303 (UMLS CUI [1,1])
C0079220 (UMLS CUI [1,2])
Unstable or clinically significant medical conditions, such as uncontrolled diabetes, cancer, etc.)
Item
Unstable or clinically significant medical conditions, such as uncontrolled diabetes, cancer, etc.)
boolean
C0443343 (UMLS CUI [1,1])
C4745084 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C0205318 (UMLS CUI [1,4])
C0011849 (UMLS CUI [1,5])
C0006826 (UMLS CUI [1,6])
Kidney disease
Item
Kidney disease
boolean
C0022658 (UMLS CUI [1,1])
Seizure disorder
Item
Seizure disorder
boolean
C0036572 (UMLS CUI [1,1])
Psychiatric condition requiring use of major tranquilizers, such as phenothiazines, butyrophenones, etc.
Item
Psychiatric condition requiring use of major tranquilizers, such as phenothiazines, butyrophenones, etc.
boolean
C0033931 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0040614 (UMLS CUI [1,3])
C0031436 (UMLS CUI [1,4])
C0006525 (UMLS CUI [1,5])
Concurrent treatment with Class 1a (e.g.: disopyramide, procainamide, quinidine) or Class III (e.g.: amiodarone, bretylium, ibutilide, sotalol) antiarrhythmic agents (medications that affect heartbeat)
Item
Concurrent treatment with Class 1a (e.g.: disopyramide, procainamide, quinidine) or Class III (e.g.: amiodarone, bretylium, ibutilide, sotalol) antiarrhythmic agents (medications that affect heartbeat)
boolean
C0205420 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0304503 (UMLS CUI [1,3])
C0012702 (UMLS CUI [1,4])
C0033216 (UMLS CUI [1,5])
C0034414 (UMLS CUI [1,6])
C0360703 (UMLS CUI [1,7])
C0002598 (UMLS CUI [1,8])
C0054040 (UMLS CUI [1,9])
C0082966 (UMLS CUI [1,10])
C0037707 (UMLS CUI [1,11])
Infection known or expected to be caused by a pathogen that is resistant to prulifloxacin
Item
Infection known or expected to be caused by a pathogen that is resistant to prulifloxacin
boolean
C3714514 (UMLS CUI [1,1])
C1314792 (UMLS CUI [1,2])
C0205309 (UMLS CUI [1,3])
C1517001 (UMLS CUI [1,4])
C0332325 (UMLS CUI [1,5])
C0527129 (UMLS CUI [1,6])
History of allergy or serious adverse reaction to prulifloxacin or any other fluoroquinolone, such as ciprofloxacin
Item
History of allergy or serious adverse reaction to prulifloxacin or any other fluoroquinolone, such as ciprofloxacin
boolean
C0262926 (UMLS CUI [1,1])
C4684772 (UMLS CUI [1,2])
C0013182 (UMLS CUI [1,3])
C0527129 (UMLS CUI [1,4])
C0949665 (UMLS CUI [1,5])
C0008809 (UMLS CUI [1,6])
Failed therapy with a fluoroquinolone for any reason within the past three months
Item
Failed therapy with a fluoroquinolone for any reason within the past three months
boolean
C0231175 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0949665 (UMLS CUI [1,3])
C4086725 (UMLS CUI [1,4])
Unable to tolerate oral therapy
Item
Unable to tolerate oral therapy
boolean
C1299582 (UMLS CUI [1,1])
C0013220 (UMLS CUI [1,2])
C0559681 (UMLS CUI [1,3])
Unable or unwilling to comply with the study protocol, including swallowing tablets, having blood drawn, and providing stool samples as scheduled
Item
Unable or unwilling to comply with the study protocol, including swallowing tablets, having blood drawn, and providing stool samples as scheduled
boolean
C0558080 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0725694 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0993159 (UMLS CUI [1,5])
C1277698 (UMLS CUI [1,6])
C1550661 (UMLS CUI [1,7])
C0205539 (UMLS CUI [1,8])