None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be Prulifloxacin 600 mg PO QD for 3 days on an empty stomach.
Group name:GROUP 2 Type of group
This group will be Prulifloxacin Placebo PO QD for 3 days on an empty stomach.
Sponsors
OPTIMER PHARMACEUTICALS, INC., BIO TRIALS PERU S.A.C.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female 18 years of age or older. 2. Is diagnosed with acute bacterial gastroenteritis. 3. Female subjects of childbearing potential must satisfy both of the following criteria: a) Nonpregnant status confirmed by the subject and not breast-feeding. b) If of childbearing age, subjects must use contraceptivas or abstinence. Subjects must agree to avoid conception during treatment and for 4 weeks following the end of study treatment. 4. Must be a traveler from an industrializad country. 5. Must have read and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Known or suspected infection or coinfection with a nonbacterial pathogen. 2. Symptoms of acute gastroenteritis of > 72 hours duration. 3. Fever. 4. Bloody diarrhea. 5. Concomitant need or use of any other oral or intravenous antibacterial with expected activities against enteric bacterial pathogens. 6. History of inflammatory bowel disease. 7. Unable or unwilling to comply with study protocol. 8. Participation in other clinical research studies utilizing an investigational agent within 1 month prior to screening or within five half-lives of the investigational agent, whichever is longer. 9. Unstable or clinically significant medical conditions. 10. Greater than two doses of an antidiarrheal medication within 24 hours prior to study entry or the anticipated need for such therapy during study treatment. 11. Inability to tolerate oral therapy. 12. Infection known or expected to be caused by a pathogen that is resistant to prulifioxacin. 13. History of allergy or serious adverse reaction to prulifloxacin or any other fluoroquinolone. 14. Have had feiled therapy with any quinolone for any reason within the past 3 raonths. 15. Concurrent treatment with Class la or Class III antiarrhythmic agents. 16. Calculated creatinine clearance <4 0 mL/min. 17. Seizure disorder. 18. Psychiatric condition requiring use of major tranquilizers. 19. Treated with an antimicrobial agent within the past 30 days. 20. Subject will be in the area for less than 60 hours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: The length of time between the first dose and the documentation of the last unformed stool will be calculated. Patients diary Measure:Time to last unformed stool (TLUS), Timepoints:Clinical evaluation: At the beginning of the study and when required. Patients diary: Days 1 to 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: where 1) Clinical success will be evaluated: No watery stools and no more than 2 soft stools in a 24-hour interval. 2) Clinical failure: Worsening or permanence of symptoms after at least 48 hours of treatment. 3) Unknown: The subject was not followed up. Microbiological eradication: Absence of the original pathogen in a stool culture during the TOC visit. Measure:Clinical cure index in the TOC visit. Microbiological eradication. Timepoints:Day 1 and end of treatment visit (TOC) on days 3, 4 or 5. ; Outcome name:Clinical evaluation: During which adverse events will be evaluated according to the Medical Dictionary of Regulatory Activities (MedDRA). The vital signs of the subjects will also be evaluated. Laboratory tests: Blood chemistry and serum chemistry panels, urinalysis. Measure:Safety of treatment: Adverse events. Laboratory exams. Evaluation of vital signs. Timepoints:Clinical evaluation of adverse events: Days and 8 and during follow-up (Days 33-37) Evaluation of vital signs: Days 1 to 8. Laboratory tests: Day 1 and during the visit 4 (days 6-8). | — |
Countries
Peru, United States
Outcome results
None listed