None listed
Conditions
Interventions
Group 1 Type of group
From day 1 to day 5, one tablet of 300 mg of faropenem daloxato will be given orally twice a day and a placebo capsule three times a day. From day 6 to 10 you will be given a placebo pill of faropenem daloxato twice a day and a placebo capsule three times a day.
Group name:Group 2 Type of group
From day 1 to day 10, these patients will be given a placebo pill of faropenem daloxato orally twice a day and a penicillin V capsule three times a day.
Sponsors
BAYER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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 ( 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Measure:Microbiological eradication at 4-8 days after the end of treatment Timepoints:at 4-8 days after the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Maintenance of the negative result for S. pyogenes in the culture of the pharyngeal sample. Measure:Bacteriological response at the follow-up visit (at 21-28 after treatment) Timepoints:at 21-28 after treatment ; Outcome name:Disappearance of acute signs and symptoms related to the infection; treatment with the study drug is continued. Measure:Clinical response during treatment (at 3-5 after the start of treatment) Timepoints:at 3-5 days after the start of treatment ; Outcome name:Disappearance of acute signs and symptoms related to infection or sufficient improvement so that additional or alternative antimicrobial therapy is not necessary. Measure:Clinical response at the check-up visit (4-8 days after treatment) Timepoints:4-8 days after treatment ; Outcome name:Continued absence of acute signs and symptoms related to the infection, so that no additional or alternative antimicrobial therapy is necessary. Measure:Clinical response at the follow-up visit (at 21-28 post-treatment days) Timepoints:at 21-28 post-treatment days ; Outcome name:Resolution or improvement of signs and symptoms sufficient so that an additional or alternative antimicrobial therapy is not necessary. Measure:Clinical response at the visit after the alternative treatment (2-4 days after the end of the alternative treatment) Timepoints:2-4 days after the end of the alternative treatment | — |
Outcome results
None listed