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Prulifloxacin · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Tablet |
| 2 | PLACEBO_COMPARATOR | Tablet |
| Name | Type | Description |
|---|---|---|
| prulifloxacin | DRUG | Tablet |
| Placebo | DRUG | Tablet |
Inclusion Criteria: * Diagnosis of acute bacterial gastroenteritis * Traveler from an industrialized country * Capable of giving Informed Consent Exclusion Criteria: * Fever (\>100.3 degrees) * Pregnant or Breast Feeding or Not using adequate birth control * Known or Suspected (co-)Infection with...
Prulifloxacin is being studied for acute bacterial gastroenteritis and acute gastroenteritis in adult travelers. It is an oral small molecule antibacterial agent in Phase 3 development for these infectious disease indications. It is not yet approved for these uses and remains investigational.
Prulifloxacin is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is the sponsor of the clinical program evaluating the drug in acute bacterial gastroenteritis and acute gastroenteritis in adult travelers.
Prulifloxacin is in Phase 3 clinical development. It is investigational and has not been approved for acute bacterial gastroenteritis or acute gastroenteritis in adult travelers. The Phase 3 program includes completed randomized, double-blind, placebo-controlled trials.
Prulifloxacin has been evaluated in two completed Phase 3 trials: NCT00448422, which studied prulifloxacin versus placebo in acute gastroenteritis in adult travelers in India, and NCT00392574, which compared prulifloxacin with placebo in traveler's diarrhea in the United States. Both trials enrolled adults aged 18 years and older.
Prulifloxacin is a small molecule antibacterial agent. It is being developed to treat acute bacterial gastroenteritis and acute gastroenteritis in adult travelers, conditions in which bacterial pathogens are a common cause. The drug is administered orally and is designed to act against the bacteria responsible for these gastrointestinal infections.