Prospective, double-blind, double-masked, randomized, comparative, parallel group, multicenter and multinational phase III trial to evaluate the efficacy and safety of faropenem dainxate 300 mg orally twice daily for 5 days against penicillin V 1,000,000 Ul orally three times a day for 10 days in the treatment of acute pharyngitis or streptococcal tonsillitis in adult patients.
- Conditions
- -J029 Acute pharyngitis, unspecified-J039 Acute tonsillitis, unspecifiedAcute pharyngitis, unspecifiedAcute tonsillitis, unspecifiedJ029J039
- Registration Number
- PER-020-01
- Lead Sponsor
- BAYER S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Male patient or woman with 18 or more years of age.
• Patients with a clinical diagnosis of suspected strep throat or streptococcal tonsillitis.
• Patients with a positive result in the rapid antigen detection test (RADT) for Group A p-hemolytic streptococci performed on a pharyngeal sample.
• Patients to whom a deep pharyngeal sample appropriate for the culture has been extracted before the start of treatment.
• Written informed consent signed by the patient or their legal representative before entering the study.
• Women of childbearing age, including women in the postmenopausal period for less than 1 year and / or without surgical sterilization, should use reliable contraceptive methods during exposure to the study drug. Since the interaction studies between faropenem daloxate and oral contraceptives have not been completed, a barrier method of contraception should be used during the time of administration of the study drug.
• Patients who are known carriers of S. pyogenes.
• Patients treated for pharyngitis or streptococcal tonsillitis within 30 days before inclusion in the study.
• Patients with periamigdalar abscess or other locally invasive diseases (such as otitis or meningitis)
• Pregnant or lactating patients, who use inadequate contraceptive methods or in which the pregnancy can not be ruled out.
• Patients who can not tolerate oral medication.
• Signs and symptoms or tests that suggest the existence of a viral infection of the upper respiratory tract (eg cough, acute rhinorrhea, conjunctivitis, positive results in the reaction of heterophile antibodies).
• History of rheumatic fever or glomerulonephritis.
• Patients with known neutropenia (<1,000 / mm3),
• Patients with known AIDS (guideline, if data are available: CD4 count <5on / mm3) or under highly active antiretroviral therapy (HAART). An HIV test is not required.
• Patients with known significant hepatic impairment (baseline serum transaminases> twice the upper normal limit or bilirubin> 1.5 times the upper normal limit).
• Patients with known renal insufficiency (serum creatinine> 2.0 mg / dl, 177 umol / l)
• Patients who have been diagnosed with a disease of rapid fatal outcome, with death expected in 2 months
• Patients requiring other systemic antibiotics during the study.
• Patients who have received a systemic antibacterial agent during the 3 days prior to inclusion
• Patients with a history of allergy to beta-lactams (penicillins, cephalosporins, penemes, etc.), or related compounds.
• Patients who have already participated in this trial or in any study on faropenem daloxato.
• Patients who have taken any investigational drug in the last 30 days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Culture of the pharyngeal sample with negative result for S. pyogenes. Culture carried out from a sample extracted in the visits of check of cure.<br>Measure:Microbiological eradication at 4-8 days after the end of treatment<br>Timepoints:at 4-8 days after the end of treatment<br>
- Secondary Outcome Measures
Name Time Method