Safety and Efficacy of Prulifloxacin Versus Placebo in Traveler´s Diarrhea

Not Applicable

• Conditions: -A09 Diarrhoea and gastroenteritis of presumed infectious origin; Diarrhoea and gastroenteritis of presumed infectious origin; A09

• Registration Number: PER-026-06
• Lead Sponsor: OPTIMER PHARMACEUTICALS, INC., BIO TRIALS PERU S.A.C.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified